[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6562-6565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02236]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5973]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Health Care Providers' Understanding of Opioid 
Analgesic Abuse Deterrent Formulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on research entitled ``Health Care Providers' 
Understanding of Opioid Analgesic Abuse Deterrent Formulations.'' This 
research consists of a survey examining the health care providers' 
current perceptions, understanding, and behaviors related to opioid 
analgesic abuse deterrent formulations (ADFs) and a study exploring the 
effectiveness of different terminology and descriptions for these 
products.

DATES: Submit either electronic or written comments on the collection 
of information by April 6, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://

[[Page 6563]]

www.regulations.gov will be posted to the docket unchanged. Because 
your comment will be made public, you are solely responsible for 
ensuring that your comment does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your comments, 
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-5973 for ``Agency Information on Collection Activities; 
Proposed Collection; Comment Request; Health Care Providers' 
Understanding of Opioid Analgesic Abuse Deterrent Formulations.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.
    For copies of the questionnaire contact: Office of Communications 
(OCOMM) Research Team, CDEROCOMMResearch@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Health Care Providers' Understanding of Opioid Analgesic Abuse 
Deterrent Formulations

OMB Control Number 0910-NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to 
conduct research relating to drugs and other FDA-regulated products in 
carrying out the provisions of the FD&C Act.
    Prescription opioids play a significant role in the opioid misuse 
and abuse epidemic in the United States. Opioid analgesics with 
properties designed to deter abuse, commonly known as ADFs, may play a 
role in helping to curb this epidemic. Currently available ADFs have 
been demonstrated to deter some forms of abuse (injection, snorting, 
or, in some cases, chewing and swallowing). FDA's own research and 
other evidence suggests considerable variability in health care 
providers' (HCPs) knowledge of and attitudes toward prescription opioid 
products and practices (Ref. 1), including understanding of ADFs. ADF 
prescription practices may present opportunities for HCPs to reduce 
opioid abuse. Conducting a comprehensive evaluation of opioid 
prescribers' knowledge, attitudes, perceptions, experiences, and 
behaviors related to ADFs will help to inform FDA's approaches to ADFs.
    Given the significance and far-reaching nature of the opioid 
crisis, along with FDA concerns about potential misunderstanding among 
HCPs about ADF terminology and capabilities, FDA determined that 
systematic research was necessary to provide the detailed and 
comprehensive

[[Page 6564]]

evidence on which to base the Agency's ADF-related policy, regulatory, 
and communication decisions, including potential alternative language 
that may be necessary to describe and explain these products. This work 
aligns with Priority 1 of the FDA's Strategic Policy Roadmap (https://www.fda.gov/about-fda/reports/healthy-innovation-safer-families-fdas-2018-strategic-policy-roadmap), and the Department of Health and Human 
Services (HHS) and the White House have similarly placed high 
priorities on addressing the epidemic of misuse and abuse of opioid 
drugs harming U.S. families.
    The study's purpose is to explore and assess the ADF-related 
knowledge, attitudes, and behaviors among opioid prescribers 
(physicians, nurse practitioners and physician assistants) and 
dispensers/pharmacists, including the related terms addiction and abuse 
deterrence, and to explore possible alternative language for describing 
these products. Phase 1 consists of focus groups (OMB approval under 
control number 0910-0695). The research described in this notice 
represents Phases 2 and 3 of the overall project.
    Phase 2 will consist of a survey based on the Phase 1 focus group 
findings related to: (1) Health care provider understanding of 
addiction, abuse, and abuse deterrent formulations; (2) attitudes 
toward, perceptions about, and experiences with abuse-deterrent opioid 
analgesics and abuse deterrence, including prescribing decisions and 
practices, potential barriers to using ADFs, the quality and 
understandability of the ADF nomenclature, and the underlying reasons 
for these perceptions; and (3) HCPs' ideas for minimizing confusion 
about ADFs, the kinds of ADF training needed, and suggested language/
terms they believe would best convey the concept of abuse deterrence to 
HCPs. The objective of the survey will be to determine the prevalence 
of HCP knowledge, attitudes, behaviors and perceptions identified 
through the qualitative discussion occurring in the Phase 1 focus 
groups and to uncover any subgroup differences among opioid prescribers 
and dispensers. We will conduct one pretest, averaging not longer than 
20 minutes, to pilot the main survey procedures among the target HCP 
populations. The main survey will also average 20 minutes.
    Phase 3 will build on findings from the Phase 1 focus groups and 
Phase 2 survey and will consist of an experimental study examining 
variations in descriptive terminology for abuse deterrent formulation 
products. We will conduct two pretests, each averaging not longer than 
20 minutes, to test the experimental manipulations and pilot the main 
study procedures. The main study procedure will also average 20 minutes 
in length. Participants will be randomly assigned to read one 
description of an abuse deterrent formulation prescription drug product 
and then complete a questionnaire that assesses their comprehension and 
perceptions of the information, including terminology. We will test up 
to four variations in wording, including the description of ADF 
included in FDA's guidance ``Abuse Deterrent Opioids--Evaluation and 
Labeling'' (Ref. 2).
    For all phases of this research, we will recruit adult health care 
professional volunteers 18 years of age or older. We will exclude 
individuals who work for HHS or work in the health care, marketing, or 
pharmaceutical industries. The sample will consist of 10 percent 
pharmacists, at least half of whom dispense ADF opioids. The other 90 
percent will be prescribers who, at the time they are recruited, spend 
at least 50 percent of their time seeing patients and who have 
prescribed opioids to at least five different patients in the last 30 
days, with at least half of the opioids they prescribe being for 
chronic non-cancer pain. The prescriber sample will be segmented to 
include 70 percent primary care providers (i.e., those practicing in 
family practice, or internal or general medicine) and 30 percent a mix 
of specialists practicing in a variety of fields such as rheumatology, 
neurology, anesthesiology, pain management, emergency medicine, 
surgery, orthopedics, and physical medicine and rehabilitation. In each 
of these groups, 60 to 70 percent will consist of physicians, 15 
percent nurse practitioners, and 15 percent physician assistants. A 
minimum of 30 percent must have experience prescribing an ADF opioid.
    We will use soft quotas to ensure that our sample includes a 
diversity of participants, including related to age, race/ethnicity, 
gender, years and location of practice, and opioid prescribing levels. 
We will also exclude pretest participants from the main studies, and 
participants will not be able to participate in more than one phase of 
the project. With the sample sizes described below, we will have 
sufficient power to detect primarily small-sized effects for Phases 2 
and 3.
    FDA estimates the burden of this collection of information as 
follows:

                                                    Table 1--Estimated Annual Reporting Burden 1 2 4
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                                                  Number of       Number of
                   Activity                      respondents    responses per   Total annual          Average burden per response           Total hours
                                                     \3\         respondent       responses
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                                                                         Phase 2
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Pretest screener.............................             470               1             470  0.17 (10 minutes)........................           79.90
Pretest......................................             235               1             235  0.33 (20 minutes)........................           77.55
Survey screener..............................           2,120               1           2,120  0.17 (10 minutes)........................          360.40
Survey.......................................           1,060               1           1,060  0.33 (20 minutes)........................          349.80
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                                                                         Phase 3
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Pretests screener............................             732               1             732  0.17 (10 minutes)........................          124.44
Pretests.....................................             366               1             366  0.33 (20 minutes)........................          120.78
Main study screener..........................           2,120               1           2,120  0.17 (10 minutes)........................          360.40
Main study...................................           1,060               1           1,060  0.33 (20 minutes)........................          349.80
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................        1,823.07
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Includes total burden for project phases 2 and 3.
\3\ Includes 10 percent overage.

[[Page 6565]]

 
\4\ With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached. Those
  participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With this in mind,
  we have included an additional 10 percent over our target number of valid completes to account for some overage.

II. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

    1. Hwang, C.S., L.W. Turner, S.P. Kruszewski, et al. ``Primary 
Care Physicians' Knowledge and Attitudes Regarding Prescription 
Opioid Abuse and Diversion.'' The Clinical Journal of Pain, 32(4), 
279-284, 2016.
    2. * FDA (2015). ``Abuse Deterrent Opioids--Evaluation and 
Labeling: Guidance for Industry.'' Available from https://www.fda.gov/downloads/Drugs/Guidances/UCM334743.pdf.

    Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02236 Filed 2-4-20; 8:45 am]
 BILLING CODE 4164-01-P


