Notice of Closed Meeting, 39441 [2018-17043]
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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0558]
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–17042 Filed 8–8–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
ACTION:
sradovich on DSK3GMQ082PROD with NOTICES
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting.
The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title
5 U.S.C., and the Determination of the
Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463.
Name of Committee: Safety and
Occupational Health Study Section
(SOHSS), National Institute for
Occupational Safety and Health
(NIOSH).
Dates: October 16–October 18, 2018.
Time: 8:00 a.m.–5:00 p.m., EDT.
Place: Embassy Suites, 1900 Diagonal
Road, Alexandria, VA 22314.
Agenda: The meeting will convene to
address matters related to the conduct of
Study Section business and for the
study section to consider safety and
occupational health-related grant
applications.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Review Officer,
NIOSH, 1095 Willowdale Road,
Morgantown, WV 26506, (304) 285–
5976; nturner@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
VerDate Sep<11>2014
18:11 Aug 08, 2018
Jkt 244001
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 September
10, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Disclosures in Professional and
Consumer Prescription Drug
Promotion.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Notice of Closed Meeting
BILLING CODE 4163–18–P
Food and Drug Administration,
HHS.
Centers for Disease Control and
Prevention
[FR Doc. 2018–17043 Filed 8–8–18; 8:45 am]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Disclosures in
Professional and Consumer
Prescription Drug Promotion
Disclosures in Professional and
Consumer Prescription Drug Promotion
39441
FDA to conduct research relating to
drugs and other FDA regulated products
in carrying out the provisions of the
FD&C Act.
FDA regulates prescription drug
advertising and promotional labeling
directed to healthcare professionals
(HCPs) and consumers (section 502(a)
and (n), respectively, of the FD&C Act
(21 U.S.C. 352(a) and (n))). In the course
of promoting their products,
pharmaceutical sponsors (sponsors) may
present a variety of information
including the indication, details about
the administration of the product,
efficacy information, and clinical trial
data. To present often complicated
information concisely, sponsors may not
include relevant information in the
body of the text or visual display of the
claim. Additionally, sponsors may not
always present limitations to the claim
in the main body of the text or display.
In these cases, sponsors typically
include disclosures of information
somewhere in the promotional piece.
There is limited published research
on disclosures in prescription drug
promotion, either directed to consumers
or to HCPs. The use of disclosures is one
method of communicating information
to HCPs and consumers about scientific
and clinical data, the limitations of that
data, and practical utility of that
information. These disclosures may
influence HCP and consumer
comprehension and decision making,
and may affect how and what treatment
HCPs prescribe for their patients.
Previous research on the effectiveness of
disclosures has been conducted
primarily in the dietary supplement
arena (Refs. 1–4). Thus, the proposed
research will examine the effectiveness
of clear and conspicuous disclosures in
prescription drug promotion directed to
both populations. The purpose of our
study is to determine how useful
disclosures regarding prescription drug
information are when presented
prominently and adjacent to claims.1
Specifically, are HCPs and consumers
able to use disclosures to effectively
frame information in efficacy claims in
prescription drug promotion?
To address this research question, we
have designed a set of studies that cover
both consumers and HCPs, as well as
three presentations addressing different
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
1 The Federal Trade Commission (FTC), which
regulates the advertising of non-prescription drug
products as well as other non-FDA regulated
products (e.g., package goods, cars, etc.) issued a
specific position on disclosures (Ref. 5) for the
advertising it regulates. Specifically, FTC explains
that disclosures must be ‘‘clear and conspicuous’’;
in other words, in understandable language, located
near the claim to be further clarified, and not
hidden or minimized by small font or other
distractions.
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Page 39441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17043]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Closed Meeting
In accordance with Section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the following meeting.
The meeting will be closed to the public in accordance with
provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C.,
and the Determination of the Director, Management Analysis and Services
Office, CDC, pursuant to Public Law 92-463.
Name of Committee: Safety and Occupational Health Study Section
(SOHSS), National Institute for Occupational Safety and Health (NIOSH).
Dates: October 16-October 18, 2018.
Time: 8:00 a.m.-5:00 p.m., EDT.
Place: Embassy Suites, 1900 Diagonal Road, Alexandria, VA 22314.
Agenda: The meeting will convene to address matters related to the
conduct of Study Section business and for the study section to consider
safety and occupational health-related grant applications.
For Further Information Contact: Nina Turner, Ph.D., Scientific
Review Officer, NIOSH, 1095 Willowdale Road, Morgantown, WV 26506,
(304) 285-5976; [email protected].
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2018-17043 Filed 8-8-18; 8:45 am]
BILLING CODE 4163-18-P
