National Institute of Dental & Craniofacial Research; Notice of Closed Meeting, 18407 [2015-07738]
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Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Food and Drug Administration
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
[Docket No. FDA–2014–N–0554]
tkelley on DSK4VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, National
Institute of Dental and Craniofacial
Research.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), title 5 U.S.C., as amended for
the review, discussion, and evaluation
of individual intramural programs and
projects conducted by the National
Institute of Dental & Craniofacial
Research, including consideration of
personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, National Institute of Dental and
Craniofacial Research.
Date: May 28–29, 2015.
Time: May 28, 2015, 12:00 p.m. to 5:40
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, Room 117, NIH Campus,
Bethesda, MD 20892.
Time: May 29, 2015, 8:00 a.m. to
Adjournment.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 30, Room 117, NIH Campus,
Bethesda, MD 20892
Contact Person: Alicia J. Dombroski, Ph.D.,
Director, Division of Extramural Activities,
Natl Inst of Dental and Craniofacial Research,
National Institutes of Health, Bethesda, MD
20892, (301) 594–4805.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcr.nih.gov/about/
CouncilCommittees.asp, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: March 31, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–07738 Filed 4–3–15; 8:45 am]
BILLING CODE 4140–01–P
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18:14 Apr 03, 2015
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Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Comparative Price
Information in Direct-to-Consumer and
Professional Prescription Drug
Advertisements
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.
DATES: Fax written comments on the
collection of information by May 6,
2015.
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, ‘‘Comparative Price Information in
Direct-to-Consumer and Professional
Prescription Drug Advertisements.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, 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:
Comparative Price Information in
Direct-to-Consumer and Professional
Prescription Drug Advertisements—
(0910–NEW)
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
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18407
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
By their very nature, medical and
health decisions are comparative (e.g.,
treat versus not treat). For consumers,
these decisions may include the use of
prescription drug products versus over
the counter products versus herbal
supplements, as well as one
prescription brand versus another
prescription brand. Similarly,
advertising is often comparative. In
prescription drug advertising, sponsors
are permitted to include truthful, nonmisleading information about the price
of their products in promotion. This
may extend to price comparison
information, wherein sponsors may
include information about the price of a
competing product in order to make
advantageous claims. Currently, when
price comparisons are made, the
advertisement (ad) should also include
context that the two drugs may not be
comparable in terms of efficacy and
safety and that the acquisition costs
presented do not necessarily reflect the
actual prices paid by consumers,
pharmacies, or third party payers.
Despite the inclusion of this additional
information, there is concern that
adding contextual information about
efficacy or safety is not sufficient to
correct the impression that the products
are interchangeable and that price is the
main factor to consider. The Office of
Prescription Drug Promotion plans to
investigate, through empirical research,
the impact of price comparison
information and additional contextual
information on prescription drug
product perceptions. This will be
investigated in direct-to-consumer
(DTC) and healthcare-directed
professional advertising for prescription
drugs.
Design Overview and Procedure
The design consists of two pretests
and a main study. We will conduct two
sequential pretest waves prior to main
data collection. The purpose the pretests
are to: (1) Ensure the stimuli are
understandable and viewable; (2)
identify and address any challenges to
embedding the stimuli within the online
survey; and (3) ensure the study
questions are appropriate and meet the
study’s goals. Participants in the
pretests will be randomly assigned to
one of two versions of an ad. One
version will present information about
the price of the product relative to a
competitor for the same indication
(Price Comparison). Another version
will present this information with
additional contextual information that
the two drugs may not be comparable in
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]]>Agencies
[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Page 18407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07738]
[[Page 18407]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
Board of Scientific Counselors, National Institute of Dental and
Craniofacial Research.
The meeting will be closed to the public as indicated below in
accordance with the provisions set forth in section 552b(c)(6), title 5
U.S.C., as amended for the review, discussion, and evaluation of
individual intramural programs and projects conducted by the National
Institute of Dental & Craniofacial Research, including consideration of
personnel qualifications and performance, and the competence of
individual investigators, the disclosure of which would constitute a
clearly unwarranted invasion of personal privacy.
Name of Committee: Board of Scientific Counselors, National
Institute of Dental and Craniofacial Research.
Date: May 28-29, 2015.
Time: May 28, 2015, 12:00 p.m. to 5:40 p.m.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institutes of Health, Building 30, Room 117, NIH
Campus, Bethesda, MD 20892.
Time: May 29, 2015, 8:00 a.m. to Adjournment.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Institutes of Health, Building 30, Room 117, NIH
Campus, Bethesda, MD 20892
Contact Person: Alicia J. Dombroski, Ph.D., Director, Division
of Extramural Activities, Natl Inst of Dental and Craniofacial
Research, National Institutes of Health, Bethesda, MD 20892, (301)
594-4805.
Information is also available on the Institute's/Center's home
page: https://www.nidcr.nih.gov/about/CouncilCommittees.asp, where an
agenda and any additional information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral
Diseases and Disorders Research, National Institutes of Health, HHS)
Dated: March 31, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-07738 Filed 4-3-15; 8:45 am]
BILLING CODE 4140-01-P
