Memo_0925-0538_Change Request_3-13-13

Date: March 13, 2013 (Revised based on Teleconference with OMB)

November 27, 2012 (originally written)

TO: Office of Management and Budget (OMB)

Through: Seleda Perryman, Report Clearance Officer, NIH

Vivian Horovitch-Kelley, NCI OMB Project Clearance Liaison, NCI

FROM: Bradford Hesse, Project Officer,

Health Information National Trends Survey 4 (HINTS 4),

Division of Cancer Control and Population Sciences,

National Cancer Institute/NIH

SUBJECT: Health Information National Trends Survey 4 (HINTS 4),

OMB No. 0925-0538, exp. 10/31/14

A conference call between the HINTS program staff and OMB occurred on 1/9/2013 in which the changes below were presented. The program staff submitted additional information on 1/23/2013 about the collection of tobacco information that is part of the FDA Cycle (see Attachments 1 and 2). Based on an email from OMB (via NIH) on 2/14/2014, OMB said it was okay to move forward with this change request.

In a separate request to OMB, the HINTS program staff has also submitted a request to conduct cognitive interviewing for the FDA Cycle of the HINTS Survey 4 (OMB No. 0925-0589).

This memo is a formal request for changes to the information collection for the HINTS 4. The changes include:

1. Inform OMB about a partnership between NCI and FDA;

2. Request a change in the burden estimate tables;

3. Request to add survey items not included in previous HINTS submissions;

4. Inform OMB of a revision in the study’s data collection timeline; and

For reference, OMB clearances for HINTS 4 data collection are illustrated in Table 1 below.

Table 1: Data Collection Already Conducted for HINTS 4

Cycle 1 data collection	Clearance granted 10/17/11 Cycle 1, as well as for 2, 3, and 4 based on the agreement that HINTS staff would contact OMB to determine whether a change request or a revision should be submitted. Cycle 2 Clearance granted 6/21/12 in a Change request.	OMB No. 0925-0538, exp. 10/31/14
Cycle 2 data collection
Cycle 3 data collection
Cycle 4 data collection

In addition, HINTS 4 has received clearances under a generic sub-study to conduct several rounds of cognitive testing. The OMB clearances for this testing are illustrated in Table 2.

Table 2: Pretesting Already Conducted for HINTS 4

Focus Groups for the development of cover letters	OMB No. 0925-0589-06, exp. 5/31/11
Cognitive testing of Cycle 1 instrument	OMB No. 0925-0589-09, exp. 5/31/11
Pilot Test	OMB No. 0925-0589-10, exp. 5/31/11
Cognitive testing of Cycle 2 instrument	OMB No. 0925-0589-03, exp. 4/30/14

1. Purpose and Research Goals of the HINTS Partnership with FDA

The HINTS program has a longstanding relationship with partners at FDA who use risk communication data to inform practice in the area of tobacco prevention, food and device recall, and supplement labeling. In order to fulfill its mission of protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation, FDA relies on HINTS for communication surveillance in order to pursue data-driven regulations and health communication endeavors.

Because of its primary focus on health communication access, usage, and cognitions, HINTS is uniquely positioned to examine communication-related constructs that are relevant to FDA’s health communication endeavors. FDA would like to initiate a specific data collection to delve more deeply into these issues. The protocol for HINTS 4 follows a postal administration using print instruments, which means that survey items can maximize opportunities to display images relevant to the mission and practice of FDA (e.g., labels, advertising, claims) and measure knowledge, attitudes, beliefs, and intentions resultant of exposure to those images.

Because communication inequalities and tobacco use are socially patterned by SES gradients, the HINTS FDA cycle will oversample high poverty census tracts. This should allow for significantly larger numbers of low SES participants (including those with low health literacy) and larger numbers of current and former smokers than the standard HINTS 4 sampling strategy, allowing FDA to collect data from its most vulnerable constituents.

Below is a description of the specific FDA partners and their research goals for the additional round of HINTS 4 data collection. These research goals, while similar to those of the rest of HINTS 4, are specific to tobacco use while still maintaining the health communications / information focus of HINTS.

FDA Center for Tobacco Products (Cathy Backinger, Ph.D.)

• HINTS will collect data relevant to the Family Smoking Prevention and Tobacco Control Act. Data will be used to inform FDA’s tobacco prevention campaigns and tobacco control outreach and education.

• Constructs of Interest:

  • Tobacco use phenotypes and standard demographics

  • HINTS communication core items (e.g., Internet and technology use, social networks, traditional media use, health information seeking, health information exposure, trust, etc.—these are included in each HINTS cycle)

  • Tobacco product advertising

  • Graphic warning labels

  • Product pack color gradations and resultant beliefs about harm

  • Menthol

  • Risk perceptions about new tobacco products (snus, e-cigarettes, dissolvables, little cigars)

  • Tobacco product claims and labels (organic, natural)

  • Product constituents

  • Attitudes and beliefs about product regulation and its impact on perceived product safety

  • Attitudes toward source attribution for tobacco control messaging

FDA Office of the Commissioner (Miriam Campbell, Ph.D.)

• Extension of prior partnership and co-funding of HINTS 4 Cycle 1, where the FDA OC fielded ~40 HINTS items related to medical devices. HINTS FDA data will be used to inform FDA’s outreach efforts during food, product, and device recalls.

• Constructs of Interest:

  • Food, product, and device recall

  • Information seeking and trust in recall information

FDA Center for Food Science and Nutrition (Jordan Lin, Ph.D.)

• New partnership based on mutual areas of interest, building off of prior HINTS questions related to food and menu labeling.

• Constructs of Interest

  • Understanding of vitamin and supplement labels claiming “anticarcinogenic” effects

  • Nutritional supplements and cancer; cancer causes and risk perceptions

2. Requested Change in Annualized Burden

The methodology to be used for the FDA cycle of HINTS will be the same as is being used for all the other cycles: a 30-minute paper survey sent by mail in both English and Spanish with one member of the household asked to complete the instrument. The mailing would occur between Cycle 3 and Cycle 4, approximately in September 20, 2013 (refer to Table 5). In order to add an additional round of data collection to HINTS 4, NCI would like to request a change in the burden estimate tables. The additional round of data collection would increase the respondent hour burden from 7,033 hours to 8,783 hours. The revised respondent burden is show in Table 3 below, with the new data collection cycle highlighted.

Table 3: Revised estimate of respondent hour burden

Data Collection Cycle	Type of respondent	Number of respondents	Frequency of response	Average time per response Minutes/Hour	Annual hour burden
Cycle 1	Mail survey	3,533	1	30/60	1,767
Cycle 2	Mail survey	3,533	1	30/60	1,767
Cycle 3	Mail survey	3,500	1	30/60	1,750
FDA Cycle	Mail survey	3,500	1	30/60	1,750
Cycle 4	Mail survey	3,500	1	30/60	1,750
Total		17,566			8,783

The revised annualized cost to respondents is show in the Table 4 below. The total cost would increase from $151,005 to $189,822.

Table 4: Revised annualized cost to respondents

Data Collection Cycle	Number of respondents	Frequency of response	Average time per response	Hourly Wage Rate	Respondent cost
Cycle 1	3,533	1	30/60	$21.61	$38,184.87
Cycle 2	3,533	1	30/60	$21.61	$38,184.87
Cycle 3	3,500	1	30/60	$21.61	$37,817.50
FDA Cycle	3,500	1	30/60	$21.61	$37,817.50
Cycle 4	3,500	1	30/60	$21.61	$37,817.50
Total					$189,822.24

3. Requested additional data collection instrument

The content of the proposed survey instrument to be used during the FDA cycle of HINTS can be reviewed in Attachment 3. Items that are considered “core content” of HINTS (items that are at the heart of the HINTS research agenda such as health communications) will remain in the FDA instrument, as will the demographic questions. The other sections reflect new content provided by FDA for this special HINTS cycle. These items were not included in the over-inclusive item pool that was submitted with the initial HINTS OMB package. These items are also not to be considered final, as we plan to conduct cognitive testing on them prior to fielding to ensure they are understandable and answerable by respondents and that they capture the information being sought by investigators. As with all other HINTS cycles, there will be an English instrument and a Spanish instrument, although the translation of these new items has not yet taken place.

All other study materials (cover letters, etc) will remain the same as all the other cycles of HINTS.

4. Revision to HINTS 4 timeline

NCI would like to request a change in the previously submitted data collection timeline for two reasons:

• Budget constraints at NCI: For budgetary reasons, Cycle 2 of HINTS was fielded later than originally anticipated. This results in a needed change in the overall schedule in order to space out the data collections.

• The addition of the FDA cycle: We would like to field the FDA cycle between cycles 3 and 4. All cycles need to be scheduled in such a way that contractor resources (such as labor) are available to all cycles of data collection.

Table 5 shows the package submission and data collection schedule for HINTS as agreed upon at the November 2010 conference call (see Attachment 4 for notes from meeting). Changes are show in strikeout and highlighted.

Table 5: Revised HINTS Timeline

July 2012 October 2012	Cycle 2 - Data Collection starts
October 2012 December 2012	Substudy #5 OMB package	Submit a generic sub-study to conduct cognitive testing on Cycle 3 instrument
January 2013 Feb/Mar 2013	Substudy #5 initiation	Conduct cognitive tests on Cycle 3 instrument
March 2013	Substudy #6 OMB package	Submit a generic sub-study to conduct cognitive testing on FDA cycle instrument
February 2013 May 2013	Cycle 3 - Submission Type determined by OMB	Submit Cycle 3 instrument for OMB clearance
May/Jun 2013	Substudy #6 initiation	Conduct cognitive tests on FDA cycle instrument
April 2013 July 2013	Cycle 3 - Data Collection starts
September 2013	FDA Cycle Submission Type determined by OMB	Submit FDA cycle instrument for OMB clearance
July 2013 September 2013	Substudy #6 7 OMB package	Submit a generic sub-study to conduct cognitive testing on Cycle 4 instrument
October 2013 December 2013	Substudy #6 7 initiation	Conduct cognitive tests on Cycle 4 instrument
December 2013	FDA cycle data collection starts
November 2013 March 2014	Cycle 4 - Submission Type determined by OMB	Submit Cycle 4 instrument for OMB clearance
January 2014 May 2014	Cycle 4 data collection starts

Attachments

Attachment 1: Additional information re: proposed FDA Cycle Instrument and Tobacco items

Attachment 2: Grid outlining the different tobacco information collections

Attachment 3: Proposed FDA Instrument Content

Attachment 4: Meeting Minutes for November 29, 2010 Conference Call with OMB

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