Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention to Participate, 40662-40663 [2020-14585]
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
References
The following references are on
display with 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; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. 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. Andrews, J.C. (2011). ‘‘Warnings and
Disclosures.’’ In Communicating Risks
and Benefits: An Evidence-Based User’s
Guide. Fischhoff, B., N.T. Brewer, and
J.S. Downs, (Eds). FDA: Silver Spring,
MD, pp. 149–161.
2. Russo France, K. and P. Fitzgerald Bone
(2005). ‘‘Policy Makers’ Paradigms and
Evidence from Consumer Interpretations
of Dietary Supplement Labels.’’ Journal
of Consumer Affairs, 39(1), 27–51.
3. Mason, M.J. and D.L. Scammon (2011).
‘‘Unintended Consequences of Health
Supplement Information Regulations:
The Importance of Recognizing
Consumer Motivations.’’ Journal of
Consumer Affairs, 45(2), 201–223.
4. Betts, K.R., K.J. Aikin, V. Boudewyns, M.
Johnson, et al. (2017). ‘‘Physician
Response to Contextualized PriceComparison Claims in Prescription Drug
Advertising.’’ Journal of Communication
in Healthcare, 10(3), 195–204.
5. Betts, K.R., V. Boudewyns, K.J. Aikin, C.
Squire, et al. (2018). ‘‘Serious and
Actionable Risks, Plus Disclosure:
Investigating an Alternative Approach
for Presenting Risk Information in
Prescription Drug Television
Advertisements.’’ Research in Social and
Administrative Pharmacy, 14(10), 951–
963.
6. Sullivan, H.W., A.C. O’Donoghue, K.T.
David, and N.J. Patel (2018). ‘‘Disclosing
Accelerated Approval on
Direct-To-Consumer Prescription Drug
websites.’’ Pharmacoepidemiology and
Drug Safety, 27(11), 1277–1280.
Dated: June 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14514 Filed 7–6–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Prescription Drug User Fee Act;
Stakeholder Consultation Meetings on
the Prescription Drug User Fee Act
Reauthorization; Request for
Notification of Stakeholder Intention to
Participate
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders—including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts—notify FDA of their
intent to participate in periodic
consultation meetings on the
reauthorization of the Prescription Drug
User Fee Act (PDUFA). The statutory
authority for PDUFA expires in
September 2022. At that time, new
legislation will be required for FDA to
continue collecting user fees for the
prescription drug program. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act) requires that FDA consult with a
range of stakeholders in developing
recommendations for the next PDUFA
program. The FD&C Act also requires
that FDA hold discussions (at least
every month) with patient and
consumer advocacy groups during
FDA’s negotiations with the regulated
industry. The purpose of this request for
notification is to ensure continuity and
progress in these monthly discussions
by establishing consistent stakeholder
representation.
SUMMARY:
Submit notification of intention
to participate in these series of meetings
by August 17, 2020. Stakeholder
meetings will be held monthly. It is
anticipated that they will commence in
September 2020. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The meetings will take
place virtually and will be held by
webcast only. Submit notification of
intention to participate in monthly
stakeholder meetings by email to
PDUFAReauthorization@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 301–
DATES:
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SUPPLEMENTARY INFORMATION:
I. Background
[Docket No. FDA–2020–N–1538]
AGENCY:
796–5003, Graham.Thompson@
fda.hhs.gov.
FDA is requesting that public
stakeholders—including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts—notify the Agency of
their intent to participate in periodic
stakeholder consultation meetings on
the reauthorization of PDUFA. PDUFA
authorizes FDA to collect user fees from
the regulated industry for the process
for the review of human drugs. The
authorization for the current program
(PDUFA VI) expires in September 2022.
Without new legislation, FDA will no
longer be able to collect user fees for
future fiscal years to fund the human
drug review process.
Section 736B(f)(1) of the FD&C Act
(21 U.S.C. 379h–2(f)(1)) requires that
FDA consult with a range of
stakeholders, including representatives
from patient and consumer groups,
healthcare professionals, and scientific
and academic experts, in developing
recommendations for the next PDUFA
program. FDA will initiate the
reauthorization process by holding a
public meeting on July 23, 2020, where
stakeholders and other members of the
public will be given an opportunity to
present their views on the
reauthorization. The FD&C Act further
requires that FDA continue meeting
with these stakeholders at least once
every month during negotiations with
the regulated industry to continue
discussions of stakeholder views on the
reauthorization. It is anticipated that
these monthly stakeholder consultation
meetings will commence in September
2020.
FDA is issuing this Federal Register
notice to request that stakeholder
representatives from patient and
consumer groups, healthcare
professional associations, as well as
scientific and academic experts, notify
FDA of their intent to participate in the
periodic stakeholder consultation
meetings on PDUFA reauthorization.
FDA believes that consistent
stakeholder representation at these
meetings will be important to ensure
progress in these discussions. If you
wish to participate in the stakeholder
consultation meetings, please designate
one or more representatives from your
organization who will commit to
attending these meetings and preparing
for the discussions. Stakeholders who
identify themselves through this notice
will be included in all stakeholder
consultation discussions while FDA
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Federal Register / Vol. 85, No. 130 / Tuesday, July 7, 2020 / Notices
negotiates with the regulated industry. If
a stakeholder decides to participate in
these monthly meetings at a later time,
that stakeholder may join the remaining
monthly stakeholder consultation
meetings after notifying FDA of this
intention (see ADDRESSES). These
stakeholder discussions will satisfy the
consultation requirement in section
736B(f)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding PDUFA
reauthorization, please provide
notification by email to
PDUFAReauthorization@fda.hhs.gov by
August 17, 2020. Your email should
contain complete contact information,
including name, title, affiliation,
address, email address, phone number,
and notice of any special
accommodations required because of
disability. Stakeholders will receive
confirmation and additional information
about the first meeting after FDA
receives this notification.
Dated: July 1. 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14585 Filed 7–6–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5973]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Health Care
Providers’ Understanding of Opioid
Analgesic Abuse Deterrent
Formulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Fax written comments on the
collection of information by August 6,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
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OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is ‘‘Health
Care Providers’ Understanding of
Opioid Analgesic Abuse Deterrent
Formulations.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
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 FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 abuse
deterrent formulations (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
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40663
ADFs will help to inform FDA’s
approaches to ADFs.
Given the significance and farreaching 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
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/aboutfda/reports/healthy-innovation-saferfamilies-fdas-2018-strategic-policyroadmap), and the Department of Health
and Human Services (HHS) and the
Administration 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 consisted 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
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]]>Agencies
[Federal Register Volume 85, Number 130 (Tuesday, July 7, 2020)]
[Notices]
[Pages 40662-40663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14585]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1538]
Prescription Drug User Fee Act; Stakeholder Consultation Meetings
on the Prescription Drug User Fee Act Reauthorization; Request for
Notification of Stakeholder Intention to Participate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of participation.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing
this notice to request that public stakeholders--including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts--notify FDA of their intent to participate in periodic
consultation meetings on the reauthorization of the Prescription Drug
User Fee Act (PDUFA). The statutory authority for PDUFA expires in
September 2022. At that time, new legislation will be required for FDA
to continue collecting user fees for the prescription drug program. The
Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA
consult with a range of stakeholders in developing recommendations for
the next PDUFA program. The FD&C Act also requires that FDA hold
discussions (at least every month) with patient and consumer advocacy
groups during FDA's negotiations with the regulated industry. The
purpose of this request for notification is to ensure continuity and
progress in these monthly discussions by establishing consistent
stakeholder representation.
DATES: Submit notification of intention to participate in these series
of meetings by August 17, 2020. Stakeholder meetings will be held
monthly. It is anticipated that they will commence in September 2020.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The meetings will take place virtually and will be held by
webcast only. Submit notification of intention to participate in
monthly stakeholder meetings by email to
[email protected].
FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 301-
796-5003, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that public stakeholders--including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts--notify the Agency of their intent to participate in
periodic stakeholder consultation meetings on the reauthorization of
PDUFA. PDUFA authorizes FDA to collect user fees from the regulated
industry for the process for the review of human drugs. The
authorization for the current program (PDUFA VI) expires in September
2022. Without new legislation, FDA will no longer be able to collect
user fees for future fiscal years to fund the human drug review
process.
Section 736B(f)(1) of the FD&C Act (21 U.S.C. 379h-2(f)(1))
requires that FDA consult with a range of stakeholders, including
representatives from patient and consumer groups, healthcare
professionals, and scientific and academic experts, in developing
recommendations for the next PDUFA program. FDA will initiate the
reauthorization process by holding a public meeting on July 23, 2020,
where stakeholders and other members of the public will be given an
opportunity to present their views on the reauthorization. The FD&C Act
further requires that FDA continue meeting with these stakeholders at
least once every month during negotiations with the regulated industry
to continue discussions of stakeholder views on the reauthorization. It
is anticipated that these monthly stakeholder consultation meetings
will commence in September 2020.
FDA is issuing this Federal Register notice to request that
stakeholder representatives from patient and consumer groups,
healthcare professional associations, as well as scientific and
academic experts, notify FDA of their intent to participate in the
periodic stakeholder consultation meetings on PDUFA reauthorization.
FDA believes that consistent stakeholder representation at these
meetings will be important to ensure progress in these discussions. If
you wish to participate in the stakeholder consultation meetings,
please designate one or more representatives from your organization who
will commit to attending these meetings and preparing for the
discussions. Stakeholders who identify themselves through this notice
will be included in all stakeholder consultation discussions while FDA
[[Page 40663]]
negotiates with the regulated industry. If a stakeholder decides to
participate in these monthly meetings at a later time, that stakeholder
may join the remaining monthly stakeholder consultation meetings after
notifying FDA of this intention (see ADDRESSES). These stakeholder
discussions will satisfy the consultation requirement in section
736B(f)(3) of the FD&C Act.
II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding PDUFA reauthorization, please provide
notification by email to [email protected] by August 17,
2020. Your email should contain complete contact information, including
name, title, affiliation, address, email address, phone number, and
notice of any special accommodations required because of disability.
Stakeholders will receive confirmation and additional information about
the first meeting after FDA receives this notification.
Dated: July 1. 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14585 Filed 7-6-20; 8:45 am]
BILLING CODE 4164-01-P
