ATSDR 0923-0047 GenIC Rwequest

Request for Approval under the “Generic Clearance for the Collection of
Routine Customer Feedback” (OMB Control Number: 0923-0047)
TITLE OF INFORMATION COLLECTION:
Distribution of Traceable Opioid Material§ Kits across U.S. Laboratories
PURPOSE:
The Centers for Disease Control and Prevention (CDC) developed the Traceable Opioid Material§
Kits, which provide over 150 opioid samples, including over 100 fentanyl types. These kits will
dramatically increase the laboratories’ ability to confirm which opioids are on the streets and
causing deaths. The kits are free to laboratories in the public, private, clinical, law enforcement,
research, and public health domains.
When CDC first made the kits publicly available online on 2/1/2019 (Attachment 1), the kits were
distributed on a first come/first served basis, but the demand for the kits was greater than
anticipated, and requests vastly exceeded supply. Currently, the limited information that CDC
receives when laboratories request kits does not allow CDC to prioritize by geography, capacity
or expertise, which labs receive kits nor to allocate kits to best address the opioid epidemic. Thus,
CDC proposes additional questions to requesting laboratories (Attachment 2). The questions will
allow CDC to: (1) distribute the test kits across U.S. laboratories; (2) decide on the number of kits
to send to a selected laboratory; (3) provide information in GAO audits; and (4) modify future kits
in volume and content.
Responses to these additional questions are currently collected by CDC under a Public Health
Emergency Paperwork Reduction Act (PHE PRA) Waiver (Attachment 3), and are necessary to
allow CDC to distribute the kits for maximize impact. The purpose of this GenIC request is to
obtain PRA clearance to continue this collection for future test kit distribution and after the PHE
PRA Waiver expires. The Research Determination Form for this project is also included
(Attachment 4).
DESCRIPTION OF RESPONDENTS:
Respondents will include public, private, clinical, law enforcement, research, and public health
laboratories that will request Traceable Opioid Material§ Kits.
TYPE OF COLLECTION: (Check one)
[ ] Customer Comment Card/Complaint Form
[ ] Usability Testing (e.g., Website or Software)
[ ] Focus Group

[ ] Customer Satisfaction Survey
[ ] Small Discussion Group
[x] Other: Service Delivery

_________________________________
§

TRACEABLE OPIOID MATERIAL, TOM KITS, and the TOM KITS logo are marks of the
U.S. Department of Health and Human Services.

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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.
6. 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.
Digitally signed by Stephanie I.

Stephanie I. Davis -S Davis -S

Date: 2019.04.29 09:02:14 -04'00'
Name:________________________________________________
Stephanie Davis, NCEH/ATSDR OMB PRA Coordinator

To assist review, please provide answers to the following question:
Personally Identifiable Information:
1. Is personally identifiable information (PII) collected? [x] Yes [ ] 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 [ ] No
Gifts or Payments:
Is an incentive (e.g., money or reimbursement of expenses, token of appreciation) provided to
participants? [ ] Yes [x] No

BURDEN HOURS

No. of
Respondents

Category of Respondent
Private Sector Laboratory
State or Local Laboratory
Federal Government Laboratory
Totals

1000
500
500
2000

Participation
Time Per
Response (in
hours)
6/60
6/60
6/60
6/60

Burden (in
hours)
100
50
50
200

FEDERAL COST: The estimated annual cost to the Federal government is _$20,000_which
was calculated as 20% of the FTE salary maintaining, reviewing, and summarizing the Service
Delivery question contents and answers.
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

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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?
[x] Yes[ ] No
If the answer is yes, please provide a description of both below (or attach the sampling plan)? If
the answer is no, please provide a description of how you plan to identify your potential group of
respondents and how you will select them?
Any laboratory requesting Traceable Opioid Material§ Kits will be the respondents for the
application questions. Of these, only laboratories with scheduled registration through the U.S.
Drug Enforcement Administration (DEA) will be able to receive the kits; there are roughly 1,550
of these registered laboratories. The CDC works closely with its federal partners at the DEA so
that they can announce newly available products using their registered laboratories mailing list.
Administration of the Instrument
1. How will you collect the information? (Check all that apply)
[x] Web-based or other forms of Social Media
[ ] Telephone
[ ] In-person
[ ] Mail
[ ] Other, Explain
2. Will interviewers or facilitators be used? [ ] Yes [x] No
Please make sure that all instruments, instructions, and scripts are submitted with the
request.
List of Attachments
Attachment 1 – Traceable Opioid Material§ Kits Fact Sheet
Attachment 2 – Traceable Opioid Material§ Kits Questions
Attachment 3 – PHE PRA Waiver Memo 20190329
Attachment 4 –RDF – CDC NCEH DLS Traceable Opioid Material§ Kits crrctd

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Instructions for completing Request for Approval under the “Generic
Clearance for the Collection of Routine Customer Feedback”
TITLE OF INFORMATION COLLECTION: Provide the name of the collection that is the
subject of the request. (e.g. Comment card for soliciting feedback on xxxx)
PURPOSE: Provide a brief description of the purpose of this collection and how it will be used.
If this is part of a larger study or effort, please include this in your explanation.
DESCRIPTION OF RESPONDENTS: Provide a brief description of the targeted group or
groups for this collection of information. These groups must have experience with the program.
TYPE OF COLLECTION: Check one box. If you are requesting approval of other
instruments under the generic, you must complete a form for each instrument.
CERTIFICATION: Please read the certification carefully. If you incorrectly certify, the
collection will be returned as improperly submitted or it will be disapproved.
Personally Identifiable Information: Provide answers to the questions.
Gifts or Payments: If you answer yes to the question, please describe the incentive and provide
a justification for the amount.
BURDEN HOURS:
Category of Respondents: Identify who you expect the respondents to be in terms of the
following categories: (1) Individuals or Households;(2) Private Sector; (3) State, local, or tribal
governments; or (4) Federal Government. Only one type of respondent can be selected.
No. of Respondents: Provide an estimate of the Number of respondents.
Participation Time: Provide an estimate of the amount of time required for a respondent to
participate (e.g. fill out a survey or participate in a focus group)
Burden: Provide the Annual burden hours: Multiply the Number of responses and the
participation time and divide by 60.
FEDERAL COST: Provide an estimate of the annual cost to the Federal government.
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. Please provide a description of how you plan to
identify your potential group of respondents and how you will select them. If the answer is yes,
to the first question, you may provide the sampling plan in an attachment.
Administration of the Instrument: Identify how the information will be collected. More than
one box may be checked. Indicate whether there will be interviewers (e.g. for surveys) or
facilitators (e.g., for focus groups) used.
Please make sure that all instruments, instructions, and scripts are submitted with the
request.

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