0695 GEN IC CDER SSA 2017 Ext

U.S. Food and Drug Administration
Data To Support Drug Product Communications
OMB Control No. 0910-0695

SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) research. As the
regulatory agency responsible for the safety and effectiveness of medical products including
biologics, drugs, foods, cosmetics, medical products, radiological products, and animal drugs, we
have established the information collection as a tool to assess the need for communications on
specific topics and to assist in the development and modification of communication messages.
Specifically, section 1003(d)(2)(D) of the Federal Food Drug and Cosmetic Act (the FD&C Act)
(21 U.S.C. Section 393(d)(2)(D)) authorizes FDA to conduct educational and public information
programs (21 U.S.C. Section 393(d)(2)(D). Accordingly, we are requesting approval for this
generic information collection.
FDA creates and uses a variety of media, including print (e.g., brochures, posters, fact sheets,
information kits), broadcast (e.g., Public Service Announcements, video news releases), and
electronic formats (e.g., Internet, listservs, CD-roms) to communicate with the public and health
professionals about the risks and benefits of regulated products. To ensure that such health
communication messages have the highest potential to be received, understood, and accepted by
those for whom they are intended, FDA will conduct research and studies relating to the control
and prevention of disease as authorized by Section 301 of the Public Health Service Act (42
U.S.C 241(a)). This type of research involves 1) assessing audience knowledge, attitudes,
behaviors and other characteristics for the planning/development of health messages,
communication strategies, and public information programs; 2) testing these health messages,
strategies, and program components while they are in developmental form to assess audience
comprehension, reactions, and perceptions; and 3) evaluating the final communication products
to determine the effectiveness of the messages and distribution methods.
Testing messages is a staple of best practices in communications research. Obtaining feedback
from intended audiences during the development of messages and materials is crucial for the
success of every communication program.1 The purpose of early testing is to improve materials
and strategies while revisions are still affordable and possible. Testing can also avoid potentially
expensive and dangerous unintended outcomes caused by audiences’ interpreting messages in a
way that was not intended by the drafters. By maximizing the effectiveness of messages and
strategies for reaching targeted audiences, the frequency with which communication messages
need to be modified should be greatly reduced.

1

National Cancer Institute (NCI). Making Health Communications Work: A planner’s guide, Pink Book. Pub. No.
T068. Washington, DC: U.S. Department of Health and Human Services (HHS), August 2004.

FDA must conduct testing to maximize the usefulness of its risk communications. Message
testing aligns with the major objective set forth by the Department of Health and Human
Services (DHHS) to increase the proportion of health communication activities that include
research and evaluation.2 Testing also aligns with FDA’s objectives. On September 22, 2006,
the Institute of Medicine (IOM) released the report The Future of Drug Safety: Promoting and
Protecting the Health of the Public. IOM’s report highlighted the importance of communication,
referencing FDA’s mission of “helping the public get the accurate, science-based information
[needed].” to use FDA-regulated products to improve health. More recently, FDA’s
Commissioner and Deputy Commissioner asserted that “one of the greatest challenges facing any
public health agency is that of risk communication.”3 To that end, FDA has developed a
strategic plan for risk communication. A major initiative of the strategic plan is the goal of
strengthening the science that supports effective risk communication. By identifying gaps in key
areas of public health knowledge, evaluating the effectiveness of communication messages, and
integrating knowledge gained through research/evaluation into practice, FDA will help ensure
that the public has the information they need about FDA-regulated products.
As described in our Supporting Statement, Part B, FDA will submit individual requests for
approval under this generic clearance into OMB’s ROCIS tracking system. Before being
submitted to OMB, individual collections will undergo rigorous review by FDA’s Research
Involving Human Subjects Committee (RIHSC), senior leadership within the Center from which
the proposal arose, and Paperwork Reduction Act Specialists. OMB will, in turn, provide
feedback on the individual collections within ten working days, whenever possible, as is
currently the case with other generic clearances.
2. Purpose and Use of the Information
The information collected will serve two major purposes. First, formative research will provide
qualitative information about target audiences – their needs, decision-making processes, and
misperceptions – that is critical to initial communications planning and development. Different
formative research will have different foci, depending on the audience addressed and the
questions needing to be answered to develop effective communications. For example, FDA must
explore consumers’ beliefs and perceptions about using drugs to formulate the basic objectives
of its risk communication campaigns. To effectively inform consumers about the risks and
benefits of use of drugs, FDA must understand critical influences on people’s decision-making
process when choosing to use, not use, or stop using drugs. Qualitative information on decisionmaking processes will also give FDA a better understanding of the needs of its different target
audiences.

2

U.S. Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health. 2nd
ed. Washington, DC: U.S. Government Printing Office, November 2000.
3
Hamburg, M.A., & Sharfstein, J.M. The FDA as a Public Health Agency. New England Journal of Medicine, 360
(24), 2493-2495, June 11, 2009.

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FDA must also understand the general beliefs of physicians and healthcare adjuncts. Prescribers
and technicians, including nurses, play a key role in the use of drugs. FDA must determine their
informational needs and the most effective communication channels and formats for reaching
and educating them about new warnings and guidelines. This information will allow FDA to
engage healthcare professionals as partners in safe and effective use of drugs.
Second, initial testing will give FDA some information about the potential effectiveness of
messages and materials in reaching and successfully communicating with their intended
audiences. Testing messages with a sample of the target audience will allow FDA to refine
messages while they are still in the developmental stage. Respondents may be asked to give
their reaction to the messages in individual or group settings. Initial testing may provide
information on any of the following factors.
Attention - The extent to which factors such as language, placement, typography, and
graphic images attract and hold the audience's attention.
Comprehension – The extent to which communication messages clearly convey risks,
both in terms of the needs of low-literacy audiences and with respect to plain language
principles and design.
Personal Relevance and Self-efficacy – Perceptions that communication messages apply
to target audience members personally, that the information is considered important, and
that target audience members feel they are capable of acting on the message.
Credibility – Perceptions that communication messages are credible and are being issued
by a trustworthy and knowledgeable source.
Acceptability – Detection of negative reactions and the extent to which target audience
members find communication messages to be offensive, unacceptable, or culturally
insensitive.
Behavioral Intent – The extent to which respondents think they will take action (for
example, maintain radioactive technology according to specifications) as a result of
seeing the communication messages.
Respondents' input and reactions to each of these areas provide insight into how target audiences
may react and how the messages should be formulated or revised to communicate most
effectively. Other information gathered on respondents’ gender, age, socioeconomic level,
race/ethnicity, and personal/family use of drugs provides a basis for evaluating whether the
messages may be perceived differently by various segments of the audience. For example,
selected age groups may find a particular message or graphic image more compelling than other
age groups.

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Systematic communications testing has been widely adopted by health education program
planners as an integral step in the development and targeted dissemination of messages and
materials. Through communications testing FDA is able to better understand characteristics of
the target audience–its attitudes, beliefs, and behaviors–and use these in the development of
effective risk communications; design messages and select formats that have increased potential
to influence the target audience’s attitudes and behavior in a favorable way; help determine
promotion and distribution channels to reach the target audience with appropriate messages; and
expend limited program resource dollars wisely and effectively.
The targeted population to respond to the particular questions, and the specific questions, will
change depending on the particular topic in question.
3. Use of Information Technology and Burden Reduction
The information will be collected through one-on-one telephone or in-person interviews, focus
groups, or self-administered surveys, depending upon the target audience being questioned,
expectations about whether the information will be evaluated in an individual or group context,
and the need to present visual stimuli (e.g., graphic displays of negative health outcomes). As
computer technology has continued to improve and become more widespread, opportunities to
test messages on the Internet using either Web-based surveys or on-line focus groups have
increased. Using computer-assisted information technology to transmit data collection
instruments and/or collect responses will continue to reduce the burden on respondents. For
example, respondents can access and respond to data collection requests at a time and place that
is convenient to them, eliminating the need to travel for in-person or group interviews.
Wherever possible, FDA will make use of Web-based data collection methods.
Improved technology in the collection and processing of data will be used to reduce respondent
burden and make processing maximally efficient. Possible information technologies for testing
include the following.
Computer-Assisted Telephone Interviewing (CATI)
Surveys conducted by telephone are well suited to the use of computer-assisted telephone
interviewing technology. CATI’s technological capabilities include automated dialing,
scheduling unanswered calls or interrupted interviews for efficient callbacks, random selection of
respondents, automated skip patterns, instantaneous out-of-range checks, insertion of information
from one question to guide a subsequent question, and the automated generation of databases for
subsequent analysis. When telephone interviews are used, CATI will be employed whenever
possible.
Computer-Assisted Personal Interviewing (CAPI)
CAPI technology allows interviewers to ask questions of a respondent using a computer
to enter data. Some primary advantages of CAPI include:
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The elimination of routing and looping problems within a paper-and-pencil questionnaire.
Respondents and interviewers cannot accidentally skip questions.
Interview questions are customized to account for personal information provided by the
respondent (e.g., respondent’s age, information from previous questions).
CAPI software can automatically perform mathematical calculations and tabulations.
CAPI software checks for inadmissible or inconsistent responses.
CAPI allows interviewers to administer surveys to geographically isolated groups,
respondents without telephones or Internet access, or other difficult-to-reach populations.
CAPI eliminates errors that arise from separate data entry.
Audio and Computer-Assisted Self-Interviewing (ACASI)

ACASI software technology offers many advantages of CAPI technology, but removes
the need to have a person administer an interview; instead, survey questions are pre-recorded and
played back through the sound system of a computer, which the respondent can listen to
privately by using headphones. Respondents select an answer by pressing a key that corresponds
to one choice shown on the screen, after which answers are fed directly into a computer database.
ACASI surveys can also be administered over a telephone by entering the response on the
telephone keypad. ACASI technology is particularly useful in administering surveys to lowliteracy populations or when addressing sensitive topics that respondents may not feel
comfortable discussing in the presence of someone else.
Web-based Surveys
Web-based surveys, including those using experimental designs, are an especially
convenient option for eliciting feedback on visual stimuli. With Web-based surveys, respondents
complete an on-line survey and then submit the data electronically over the Internet. Closedended questions (e.g., multiple-choice items, Likert scales) will be employed whenever possible.
With 92% of 18 to 29 year olds indicating in April of 2009 that they use the Internet, 4 Webbased surveys offer an especially useful way to solicit responses from young adults and
adolescents and to assess the relative efficacy of alternative message presentations.
Videoconferencing
Videoconferencing uses video and satellite technology to allow a group of focus group
participants located in multiple geographic locations to interact with one another both visually
and aurally. A facilitator and a technical team located in a hub site maintain the video and audio
connections among participating sites.

4

Usage Over Time. Pew Internet & American Life Project, July 15, 2009, http://www.pewinternet.org/TrendData/Usage-Over-Time.aspx, accessed on October 6, 2009

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Internet conferencing
Internet conferencing is especially useful for discussions with specific individuals or
international participants. This format functions as a sort of “chat room” in which a moderator
intercepts and distributes e-mail transmissions from participants who have logged onto a
specially designated Web site.
Teleconferencing
Teleconferencing uses telephone technology to facilitate an exchange among participants
located in multiple geographic locations. Participants dial into a specially designated phone
number or “bridge line” that is moderated by a focus group facilitator.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. As each new communication message or
strategy is developed, FDA reviews existing literature and databases, including testing reports on
existing messages and materials to avoid duplication. FDA also consults with outside experts to
evaluate available information on similar messages with comparable audiences. In addition,
FDA will be working with DHHS, NIH, AHRQ, CMS, as well as other government agencies that
are responsible for communicating about use of drugs with population segments or the general
public. However, because risk communications on the use of drugs will be diverse and vary by
target audience, new data collection instruments generally will be prepared for each project.
5. Impact on Small Businesses or Other Small Entities
These proposed data collection activities will focus primarily on subjects in their roles as
individuals during their own time. In some instances we might want to question hospital or other
healthcare facilities staff. In most cases, we believe that such facilities are very unlikely to
include small businesses, and we will strive to avoid including small businesses unless they are a
targeted audience. If we believe that employees of small businesses should be examined, we will
ensure understanding that the information collection is completely voluntary. We anticipate the
burden on small businesses or other small entities as no more than one-half hour per respondent.
6. Consequence of Collecting the Information Less Frequently
FDA plans to use a variety of media, messages, and materials to inform and educate the public.
Sound research and evaluation are needed as integral parts of communication design. Effective
research tools help us better direct limited resources. We intend to test as frequently as is
appropriate to ensure that communications are appropriately designed.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
Because FDA’s communications testing activities will be primarily qualitative in nature, the
results are not generalizable to the population at large or the particular target audience under
study. However, the nature of communications testing is such that generalizability is not a
critical feature; the emphasis is on obtaining timely, useful information that can be fed back into
the development of new messages or materials or the revision of existing ones. There are no
special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the
Federal Register of June 19, 2017 (82 FR 27840). One comment was received requesting that
FDA publish an annual list of its planned drug product communication studies and strive to
reflect an overall work plan. The comment also noted the rather broad topic areas included in the
information collection and suggested that perhaps additional notice regarding individual studies
would allow for more meaningful feedback on whether that particular study would be necessary.
As noted in our 30 day notice of December 13, 2017 (82 FR 58622), FDA appreciates this
comment. In determining which drug product communications it will undertake, we first
consider those we believe will best address current or immediate public health issues. We also
note that, in accordance with the PRA, any proposed study under this information collection
request must first be submitted to and approved by OMB to determine whether it falls within the
scope of the collection. While we will make every effort to communicate to our stakeholders
anticipated studies so that ongoing or related research can be coordinated, we have made no
adjustments to the information collection.
9. Explanation of Any Payment or Gift to Respondents
It is standard practice in commercial market research to offer recruited respondents some form of
remuneration for the time they spend engaged in a personal interview activity. Instances for
offering a small incentive will be determined on a case-by-case basis (depending on the
particular information collection design). Small amounts of money (where appropriate, $20 or
less) may be offered as an incentive for participation in in-person interviews. As standard
practice in commercial market research, and as has been approved by OMB in the past, focus
group participants may be offered an incentive at a regionally appropriate market rate (usually
$50 to $75) as remuneration. FDA will provide a rationale in the justification memo for any
studies that propose to offer rates beyond this range. For example, incentives for Web-based or
telephone focus groups may be offered at a lower rate. Incentives for difficult-to-recruit
populations may be offered at a higher rate, with the upper bound at $300 for certain medical
specialists. Circumstances, however, do not always require that remuneration be given; many
audiences including the public, patients, survivors, and some health professionals may participate
at their own expense because of their interest or involvement in the topic, or as a professional
courtesy.

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10. Assurance of Confidentiality Provided to Respondents
Information provided by respondents will be kept private and anonymous, except as otherwise
required by law. This will be communicated to respondents by means of introductory letters,
explanatory texts on the cover pages of questionnaires, scripts read prior to focus groups or
telephone interviews, and consent forms. Respondents also will be advised of the following: the
nature of the activity; the purpose and use of the data collected; FDA sponsorship (when
appropriate5); and the fact that participation is voluntary at all times. Because responses are
voluntary, respondents will be assured that there will be no penalties if they decide not to
respond, either to the information collection as a whole or to any particular questions.
Only personnel from a contractor conducting the information collection will have access to
individual-level survey, interview, or focus group data. All project staff from a contractor
conducting the information collection must take required measures to ensure the privacy and
anonymity of data. Personally identifiable data shall be limited to information that may be
required in the process of respondent enrollment. Personally identifiable information will be
accessible to only those contractors who need them and will not be linked to interview data. All
personally identifiable data will be destroyed following interview data collection. Neither FDA
employees nor any federal employee of any other Agency will have access to this information.
All electronic and hard-copy data will be maintained securely throughout the information
collection and data processing phases. While under review, electronic data will be stored in
locked files on secured computers; hard-copy data will be maintained in secure building facilities
in locked filing cabinets. As a further guarantee of privacy and anonymity, all presentation of
data in reports will be in aggregate form, with no links to individuals preserved. Reports will be
used only for research purposes and for the development of communication messages.
Communications testing efforts described in this proposal are typically considered exempt from
the “Regulations for the Protection of Human Subjects” in accordance with paragraph (b)(3) of
45 CFR Sec. 46.101. Before data are collected, FDA researchers must obtain either an
exemption or a full approval for all research from FDA’s IRB, the Research Involving Human
Subjects Committee.
Minors (or children) are persons who have not attained the legal age for consent to treatments or
procedures involved in the research are covered under the applicable law of the jurisdiction in
which the research will be conducted. Where FDA’s IRB determines that minors are capable of
giving an assent, the IRB shall determine whether adequate provisions are made for soliciting
assent. Generally, assent requires securing the signature of a minor to the research in a separate
assent form, in addition to the consent form the parent or legal guardian signs. An assent
document should contain an explanation of the study, a description of what is required of the
subject (e.g., what they will experience (whether they will be in the hospital, whether the child's

5
In some cases, FDA sponsorship will not be made known to respondents prior to data collection out of concern for
the potential introduction of bias to study results. In such cases, FDA sponsorship will be made known after the data
are collected.

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parents will be with him or her, etc.)), an explanation of any risks and pain associated with the
study, an explanation of any anticipated change in the child's appearance, and an explanation of
the benefits to the child or others.
11. Justification for Sensitive Questions
As discussed in Questions 2 and 10 above, some studies require the inclusion of people who
match selected characteristics of the target audience that FDA is trying to reach. This may
require asking a question about race/ethnicity, income, education and/or health status on the
initial screening questionnaire used for recruiting. Potential participants are informed that this is
being done to make sure that FDA speaks with the kinds of people for whom its messages are
intended. Again, respondents are assured that the information is voluntary and will be treated as
private and anonymous. All information on race/ethnicity will comply fully with the standards
of OMB Statistical Policy Directive No. 15, October 1997
(http://www.whitehouse.gov/omb/fedreg/1997standards.html).
Because FDA communications may be concerned with the prevention of premature mortality,
some projects may involve asking questions about (or discussing) how one perceives his/her own
personal risk for serious illness. The probability of sensitive questions occurring depends upon
the topic of the communication. This information is needed to gain a better understanding of the
target audience so that the messages, strategies, and materials designed will be appropriate and
sensitive. Questions of this nature, while not as personal as those about sexual behavior or
religious beliefs, still require some sensitivity in how they are worded and approached. In faceto-face data collections, questions of this kind are generally asked later in the interview or group
discussion, when respondents are more comfortable with the interview situation and are more at
ease with the interviewer/moderator. As noted in section 10. above, participants are informed
prior to actual participation about the nature of the activity and the voluntary nature of their
participation. The interviewer/moderator makes it clear that they do not have to respond to any
question that makes them uncomfortable.
Raw data from data collections that include sensitive information (for example, screening
questionnaires and audio tapes) are not retained once the data have been extracted and
aggregated. The information is never a part of a system of records containing permanent
identifiers that can be used for retrieval.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Burden Hours
Table 1 is based on the maximum number of data collections expected on an annual
basis. It is highly unlikely that respondents will be contacted more than once per year due to the
variable nature of the medical product issues and the need to address different respondent
groups. Proposed data collection methodologies are described in more detail in Section B.

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Table 1 – Estimated Annual Reporting Burden
Activity

Number of
Respondents

No. of
Total
Responses per Annual
Respondent Responses

Individual In-Depth Interviews

820

1

820

General Public Focus Group
Interviews
Self-Administered Surveys

375

1

375

9,600

1

9,600

Intercept Interviews: Telephone

15,900

1

15,900

Self-Administered Surveys

12,700

1

12,700

Gatekeeper Reviews

1,000

1

1,000

Omnibus Surveys

3,100

1

3,100

1

0
380

TOTAL (General Public)
Physician Focus Group
Interviews
TOTAL (Overall)

380

Average
burden

Total Hours

0.75
(45 min.)
1.50
(90 min.)
0.25
(15 min.)
0.08
(5 min.)
0.25
(15 min.)
0.50
(30 min.)
0.17
(10 min.)
1.50
(90 min.)

43,875

615
563
2,400
1,270
3,175
500
527
9,050
570
9,620

12b. Annualized Cost Burden
The general public will complete the majority of data collections. The average salary for t
this group is $30.02.6 The estimated annualized annual cost for the general public in this
information collection for 4,098 hours of reporting time is $123,022. Other labor groups include
primary care physicians and medical specialists, whose average salary, respectively, is estimated
as $119.15 and $124.22. The estimated annualized annual cost for physicians in this information
collection for 572 hours of reporting time is $69,604. The estimated annualized annual cost for
4,757 hours of reporting time is $192,626. The number of respondents and length of response
was determined on the basis of FDA prior experience with communications testing and an
estimate of the communication needs of the Center for Devices and Radiological Health. The
actual numbers will vary depending upon the topic of interest.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.

6
U.S. Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_nat.htm, June 2010.
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14. Annualized Cost to the Federal Government
Costs will include contractor expenses for designing and conducting information collection
activities, specifically, drawing samples, training interviewers, collecting and analyzing
information, and reporting on findings. Because this request for generic clearance includes
various procedures for the collection of information, contractor expenses may vary from an
estimated $20,000 for a small focus group study to an estimated $150,000 for an in-depth
interview study. The maximum estimated annualized expense for contractor expenses in this
data collection is $2,180,000. In addition, government staff costs may be incurred for
monitoring by the government Project Officer, projected to be about 25% of an FTE’s time per
year (522 hours). Given an FDA personnel cost of $57.13 per hour, $29,708 would be spent
annually on government staff salaries. Thus, the total estimated annual cost to the government
for this collection of information is $2,209,708. This is equal to the total of contractor expenses
($2,180,000) plus FDA government staff salary cost ($29,708).
15. Explanation for Program Changes or Adjustments
There are no program changes to the information collection. However, we have made
adjustments to the burden hours and annual responses in keeping with the approval of a recent
change request and previous burden approval. Thus the information collection reflects an
increase to 43,875 annual responses and decrease to 9,620 total hours.
16. Plans for Tabulation and Publication and Project Time Schedule
The process for developing the analytical plan for communications testing is similar to that used
in any formal evaluation. The staff will review the material to be tested, discuss the objectives
with the individuals responsible for developing the materials, determine the analytic questions to
be addressed, and then prepare the procedures, instruments, and data analysis plan. The analyses
conducted for each project will be determined by the communication objectives, the messages
being tested, and the audience for the messages. Specifics of the analyses cannot be determined
until the messages to be tested are prepared.
Techniques include primarily qualitative analyses (for example, content analysis for in-depth
interviews), although some results, including those from central location intercept interviews or
Web-based surveys, are summarized quantitatively using descriptive statistics. In cases where
quantitative data is collected, descriptive statistics—including percentages, cross tabulations, and
averages—will be calculated and presented, along with demographic descriptions of study
respondents. Information collected from study participants will be subjected to subgroup
analyses to uncover potential differences among key groups (defined by gender, age,
race/ethnicity, etc.). Statistical analyses may be conducted using cross-tabulation procedures
with categorical variables (e.g., chi-square) and between-group procedures with continuous
variables (e.g., ANOVA and t tests). Parametric statistical tests will be used in the case of
sufficient sample sizes, normal distributions, and continuous or interval data; non-parametric
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procedures will be used otherwise. All of the analyses will be done in the context of
understanding the limitations of the data with respect to their not representing population
parameters.
While the primary purpose of this data collection is to provide information to the developers of
the messages for the purpose of improving them, FDA makes results available to a variety of
health program planners at Government agencies, voluntary organizations, health professional
organizations, and medical institutions. In addition, FDA may present the findings of its work at
professional association meetings, including those of the American Public Health Association.
Some results may be published in professional journals such as the Journal of Public Policy and
Marketing. In any findings presented at professional association meetings or in professional
journals, FDA will state the limitations of the data by recognizing the qualitative and nonrepresentative nature of the results.
The specific messages to be tested and the timing of these messages are not known at this time.
However, as indicated in section A.1., approximately 34 studies are planned. While the period
varies somewhat depending on the complexity of the testing and number of respondents required,
the typical communications testing project will require approximately 12 weeks once OMB
clearance is obtained. A schedule for a typical project is shown below:
Project Time Schedule:
Activity
Finalize materials
Finalize design
Collection of data
Analysis of data
Report results

Output
1 week after OMB approval
3 weeks after OMB approval
5 weeks after OMB approval
10 weeks after OMB approval
12 weeks after OMB approval

17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date will be displayed.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the Certification.

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