Request for Approval

Request for Approval under the “Generic Clearance for the Collection of Routine Customer Feedback” (OMB Control Number: 0920-1050)

Instruction: This form should be completed by the primary contact person from the Program sponsoring the collection.

DETERMINE IF YOUR COLLECTION IS APPROPRIATE FOR THIS GENERIC CLEARANCE MECHANISM:

Instruction: Before completing and submitting this form, determine first if the proposed collection is consistent with the scope of the Collection of Routine Customer Feedback generic clearance mechanism. To determine the appropriateness of using the Collection of Routine Customer Feedback generic clearance mechanism, complete the checklist below.

If you select “yes” to all criteria in Column A, the Collection of Routine Customer Feedback generic clearance mechanism can be used. If you select “yes” to any criterion in Column B, the Collection of Routine Customer Feedback generic clearance mechanism cannot be used.

Column A	Column B
The information gathered will only be used internally to CDC. [X ] Yes [ ] No	Information gathered will be publicly released or published. [ ] Yes [X ] No
Data is qualitative in nature and not generalizable to people from whom data was not collected. [ X] Yes [ ] No	Employs quantitative study design (e.g. those that rely on probability design or experimental methods) [ ] Yes [X ] No
There are no sensitive questions within this collection (e.g. sexual orientation, gender identity). [X ] Yes [ ] No	Sensitive questions will be asked (e.g. sexual orientation, gender identity). [ ] Yes [X ] No
Collection does not raise issues of concern to any other Federal agencies. [ X ] Yes [ ] No	Other Federal agencies may have equities or concerns regarding this collection. [ ] Yes [X ] No
Data collection is focused on determining ways to improve delivery of services to customers of a current CDC program. [X ] Yes [ ] No	Data will be used to inform programmatic or budgetary decisions, for the purpose of program evaluation, for surveillance, for program needs assessment, or for research. [ ] Yes [ X ] No
The collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the future. [X ] Yes [ ] No

Did you select “Yes” to all criteria in Column A?

If yes, the Collection of Routine Customer Feedback generic clearance mechanism may be appropriate for your investigation. You may proceed with this form.

Did you select “Yes” to any criterion in Column B?

If yes, the Collection of Routine Customer Feedback generic clearance mechanism is NOT appropriate for your investigation. Stop completing this form now.

Note: Use OMB format when asking race/ethnicity as well as gender questions.

TITLE OF INFORMATION COLLECTION: Stakeholder Engagement and Feedback -Management of Acute and Chronic Pain

PURPOSE: In 2016, CDC developed and published the CDC Guideline for Prescribing Opioids for Chronic Pain to provide recommendations for the prescribing of opioid pain medication for patients 18 years and older in primary care settings. Improving the way opioids are prescribed through clinical practice guidelines can ensure patients have access to safer, more effective chronic pain treatment while reducing the number of people who misuse or overdose from these drugs. The purpose of this project is to inform CDC’s understanding of stakeholders’ values and preferences related to pain and pain management and will complement CDC’s ongoing work assessing the need for updating or expanding the CDC Guideline for Prescribing Opioids for Chronic Pain. This project is non-research; results are non-generalizable and will be used internally to improve service delivery around the CDC Guideline for Prescribing Opioids for Chronic Pain.

Specifically, CDC will gather perspectives on pain and pain management, including but not limited to the benefits and harms of opioid use, from patients with acute or chronic pain, patients’ family members and/or caregivers, and health care providers who care for patients with pain or conditions that can complicate pain management (e.g., opioid use disorder or overdose). Project activities include up to 12 stakeholder sessions (up to 3 groups of up to 20 participants in each of the 4 geographic sites), and up to 120 individual conversations (up to 30 conversations in each of the 4 geographic sites). Those four geographic sites include (Birmingham, Alabama; Boise, Idaho; Jeffersonville, Indiana; and Pittsburgh, Pennsylvania.

During the stakeholder sessions and individual conversations, CDC will invite input specifically on topics focused on using or prescribing opioid pain medications, non-opioid medications, or non-pharmacological treatments (e.g., exercise therapy or cognitive behavioral therapy). These topics are:

• Experiences managing pain, which might include benefits, risks, and/or harms of the pain management options listed above.

• Experiences choosing among the pain management options listed above, including considering factors such as each option’s accessibility, cost, benefits, and/or risks.

• Experiences getting information needed to make pain management decisions.

Prior to summarizing and analyzing the input gathered through the individual conversations and stakeholder sessions, all personally-identifiable information that might have been provided will be removed.

DESCRIPTION OF RESPONDENTS: Respondents will include volunteers who self-identify as one or more of the following stakeholder groups: patients with acute or chronic pain, patients’ family members and/or caregivers, and health care providers who care for patients with pain or conditions that can complicate pain management (e.g., opioid use disorder or overdose). These are the groups primarily impacted by CDC’s prescribing guideline.

TYPE OF COLLECTION: (Check one)

Instruction: Please sparingly use the Other category

[ ] Customer Comment Card/Complaint Form [ ] Customer Satisfaction Survey

[ ] Usability Testing (e.g., Website or Software [ X] Small Discussion Group

[ ] Focus Group [X ] Other: Individual Conversations __

CERTIFICATION:

I certify the following to be true:

1. The collection is voluntary.

2. The collection is low-burden for respondents and low-cost for the Federal Government.

3. The collection is non-controversial and does not raise issues of concern to other federal agencies.

4. The results are not intended to be disseminated to the public.

5. Information gathered will not be used for the purpose of substantially informing influential policy decisions.

Name:_______________ Karen Angel_________________________________

To assist review, please provide answers to the following question:

Personally Identifiable Information:

1. Is personally identifiable information (PII) collected? [ ] Yes [X ] No

2. If Yes, is the information that will be collected included in records that are subject to the Privacy Act of 1974? [ ] Yes [ X] No

3. If Applicable, has a System or Records Notice been published? [ ] Yes [X ] No

Privacy Act does not apply for this information collection request (Attachment 3). Persons from the general public who are interested in participating in either an individual conversation (Attachment 1) or a stakeholder session (Attachment 2) will be directed to email CDC (a specific email address will be posted in the Federal Register Notice). From among those people who express interest by the deadline posted in the Federal Register Notice, CDC will select names at random. All data will be reported in aggregate unlinked form. All procedures have been developed, in accordance with federal, state, and local guidelines, to ensure that the rights and privacy of respondents will be protected and maintained.

Gifts or Payments:

Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to participants? [ ] Yes [ X ] No

If Yes: Please describe the incentive. If amounts are outside of customary incentives, please also provide a justification.

BURDEN HOURS

Category of Respondent	No. of Respondents	Participation Time (Hours)	Total Burden (Hours)
Patients with acute or chronic pain, Patients’ family members and/or caregivers and Healthcare providers - Individual conversations (Att. 1)	120	1.5	180
Patients with acute or chronic pain, Patients’ family members and/or caregivers and Healthcare providers - Stakeholder sessions (Att. 2)	240	2	480
Totals			660

FEDERAL COST: The estimated annual cost to the Federal government is 2,120.

If you are conducting a focus group, survey, or plan to employ statistical methods, please provide answers to the following questions:

The selection of your targeted respondents

1. Do you have a customer list or something similar that defines the universe of potential respondents and do you have a sampling plan for selecting from this universe? [ ] Yes [X ] No

If Yes: Please provide a description of both below (or attach the sampling plan)

If No: Please provide a description of how you plan to identify your potential group of respondents and how you will select them or ask them to self-select/volunteer

Persons from the general public who are interested in participating in either a stakeholder session or an individual conversation will be directed to email CDC (specific email address will be posted in the Federal Register Notice) expressing their interest and providing additional information (e.g., contact information, preferred geographic site, preferred engagement type, self-identified stakeholder group). From among those people who express interest by the deadline posted in the Federal Register Notice, CDC will select names at random from within three self-identified stakeholder groups: patients with acute or chronic pain who have experienced benefits or harms of opioid pain medication use, patients’ family members and/or caregivers, and health care providers who care for patients with pain or conditions that can complicate pain management. Participants will need to live in or travel to one of the four geographic sites (Birmingham, Alabama; Boise, Idaho; Jeffersonville, Indiana; and Pittsburgh, Pennsylvania) in order to participate. The participants in the stakeholder sessions will be different from the participants in the individual conversations (i.e., one person cannot participate in both).

Administration of the Instrument

1. How will you collect the information? (Check all that apply)

[ ] Web-based or other forms of Social Media

[ ] Telephone

[X ] In-person

[ ] Mail

[ ] Other, Explain

2. Will interviewers or facilitators be used? [X] Yes [ ] No

Please make sure that all instruments, instructions, and scripts are submitted with the request.

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