National Vaccine Advisory Committee Meetings, 34141-34142 [2010-14472]
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Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Notices
Web site for the FACA database is
https://fido.gov/facadatabase/.
Dated: June 10, 2010.
Donald B. Moulds,
Acting Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2010–14447 Filed 6–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology; HIT
Policy Committee’s Workgroup
Meetings; Notice of Meetings
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AGENCY: Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meetings.
This notice announces forthcoming
subcommittee meetings of a Federal
advisory committee of the Office of the
National Coordinator for Health
Information Technology (ONC). The
meetings will be open to the public via
dial-in access only.
Name of Committees: HIT Policy
Committee’s Workgroups: Meaningful
Use, Privacy & Security Policy,
Adoption/Certification, Enrollment,
Privacy & Security Tiger Team, and
Nationwide Health Information
Infrastructure (NHIN) workgroups.
General Function of the Committee: to
provide recommendations to the
National Coordinator on a policy
framework for the development and
adoption of a nationwide health
information technology infrastructure
that permits the electronic exchange and
use of health information as is
consistent with the Federal Health IT
Strategic Plan and that includes
recommendations on the areas in which
standards, implementation
specifications, and certification criteria
are needed.
Date and Time: The HIT Policy
Committee Workgroups will hold the
following additional public meetings
during June 2010: June 22nd Privacy &
Security Tiger Team, 10 a.m. to
1 p.m./ET; June 25th Enrollment
Workgroup, 9 a.m. to 10 a.m./ET; June
28th Enrollment Workgroup, 10 a.m. to
1 p.m./ET and Privacy & Security Tiger
Team, 2 p.m. to 4 p.m./ET. In addition,
the June 28th Privacy & Security Policy
Workgroup, 2 p.m. to 4 p.m./ET, has
been cancelled.
Location: All workgroup meetings
will be available via webcast; for
instructions on how to listen via
telephone or Web visit https://
healthit.hhs.gov. Please check the ONC
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Web site for additional information as it
becomes available.
Contact Person: Judy Sparrow, Office
of the National Coordinator, HHS, 330 C
Street, SW., Washington, DC 20201,
202–205–4528, Fax: 202–690–6079,
e-mail: judy.sparrow@hhs.gov Please
call the contact person for up-to-date
information on these meetings. A notice
in the Federal Register about last
minute modifications that affect a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice.
Agenda: The workgroups will be
discussing issues related to their
specific subject matter, e.g., meaningful
use, the NHIN, privacy and security, or
enrollment. If background materials are
associated with the workgroup
meetings, they will be posted on ONC’s
Web site prior to the meeting at
https://healthit.hhs.gov.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the workgroups. Written
submissions may be made to the contact
person on or before two days prior to
the workgroups’ meeting date. Oral
comments from the public will be
scheduled at the conclusion of each
workgroup meeting. Time allotted for
each presentation will be limited to
three minutes. If the number of speakers
requesting to comment is greater than
can be reasonably accommodated
during the scheduled open public
session, ONC will take written
comments after the meeting until close
of business on that day.
If you require special
accommodations due to a disability,
please contact Judy Sparrow at least
seven (7) days in advance of the
meeting.
ONC is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. No. 92–463, 5 U.S.C., App. 2).
Dated: June 8, 2010.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2010–14397 Filed 6–15–10; 8:45 am]
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34141
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Vaccine Advisory Committee
Meetings
AGENCY: Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice of meetings.
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the National Vaccine Advisory
Committee (NVAC) will hold two
teleconference meetings. The meetings
are open to the public. Pre-registration
is not required, however, individuals
who wish to participate in the public
comment sessions should either e-mail
nvpo@hhs.gov or call 202–690–5566 to
register.
DATES: The meeting dates are:
1. July 27, 2010, 1 p.m.–2 p.m. EDT.
2. August 25, 2010, 1 p.m.–2 p.m.
EDT.
ADDRESSES: The meetings will occur by
teleconference. To attend, please call
1–888–677–1385, passcode ‘‘NVAC.’’
FOR FURTHER INFORMATION CONTACT:
Daniel Salmon, National Vaccine
Program Office, Department of Health
and Human Services, Room 715–H,
Hubert H. Humphrey Building, 200
Independence Avenue, SW.,
Washington, DC 20201. Phone: (202)
690–5566; Fax: (202) 260–1165; e-mail:
nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to Section 2101 of the Public Health
Service Act (42 U.S.C. Section 300aa-1),
the Secretary of Health and Human
Services was mandated to establish the
National Vaccine Program to achieve
optimal prevention of human infectious
diseases through immunization and to
achieve optimal prevention against
adverse reactions to vaccines. The
National Vaccine Advisory Committee
was established to provide advice and
make recommendations to the Director
of the National Vaccine Program, on
matters related to the Program’s
responsibilities. The Assistant Secretary
for Health serves as Director of the
National Vaccine Program.
These are special meetings of the
NVAC. Discussions will focus on the
work of the Vaccine Safety Risk
Assessment Working Group (VSRAWG)
and the reports that it generates. The
reports will summarize the work to-date
of the H1N1 VSRAWG reviewing H1N1
safety monitoring data. These NVAC
meetings may also include topics
beyond the VSRAWG such as the
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34142
Federal Register / Vol. 75, No. 115 / Wednesday, June 16, 2010 / Notices
National Vaccine Plan and updates from
other Working Groups. If there is a
change in meeting dates this
information will be posted on the NVAC
Web site (https://www.hhs.gov/nvpo/
nvac/) as soon as the pertinent
information becomes available.
For these special meetings, members
of the public are invited to attend by
teleconference via a toll-free call-in
phone number. The call-in number will
be operator assisted to provide members
of the public the opportunity to provide
comments to the Committee. Public
participation and ability to comment
will be limited to space and time
available. Public comment will be
limited to no more than three minutes
per speaker. Pre-registration is required
for public comment only. Individuals
who plan to attend and need special
assistance, such as accommodation for
hearing impairment or other reasonable
accommodations, should notify the
designated contact person at least one
week prior to the meeting.
Any members of the public who wish
to have printed material distributed to
NVAC should submit materials to the
Executive Secretary, NVAC, through the
contact person listed above prior to
close of business one week before each
meeting (conference call). A draft
agenda and any additional materials
will be posted on the NVAC Web site
(https://www.hhs.gov/nvpo/nvac/) prior
to the meeting.
Dated: June 1, 2010.
Bruce Gellin,
Deputy Assistant Secretary for Health,
Director, National Vaccine Program Office,
Executive Secretary, NVAC.
[FR Doc. 2010–14472 Filed 6–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0266]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Study of Clinical
Efficacy Information in Professional
Labeling and Direct-to-Consumer Print
Advertisements for Prescription Drugs
AGENCY:
Food and Drug Administration,
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HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
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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
the Study of Clinical Efficacy
Information in Professional Labeling
and Direct-to-Consumer (DTC) Print
Advertisements for Prescription Drugs.
This study is designed to investigate
efficacy and effectiveness information of
prescription drugs as conveyed to
healthcare providers through approved
labeling and to consumers through print
advertisements.
DATES: Submit either electronic or
written comments on the collection of
information by August 16, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
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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.
Study of Clinical Efficacy Information
in Professional Labeling and Direct-toConsumer (DTC) Print Advertisements
for Prescription Drugs—New
FDA regulations require that an
advertisement that makes claims about
a prescription drug include a ‘‘fair
balance’’ of information about the
benefits and risks of the advertised
product, in terms of both content and
presentation (§ 202.1(e)(5(ii) (21 CFR
202.1(e)(5)(ii)). In past research, FDA
has focused primarily on the risk
component of the risk-benefit ratio. In
the interest of thoroughly exploring the
issue of fair balance, however, the
presentation of effectiveness, or benefit,
information is equally important.
The act requires that manufacturers,
packers, and distributors (sponsors) who
advertise prescription human and
animal drugs, including biological
products for humans, disclose in
advertisements certain information
about the advertised product’s uses and
risks.1 By its nature, the presentation of
this risk information is likely to evoke
active tradeoffs by consumers, i.e.,
comparisons with the perceived risks of
not taking treatment, and comparisons
with the perceived benefits of taking a
treatment.2 Because FDA has an interest
in fostering safe and proper use of
prescription drugs, an activity that
engages both risks and benefits, an
indepth understanding of consumers’
processing of this information is central
to this regulatory task.
Research and guidance to sponsors on
how to present benefit and efficacy
information in prescription drug
advertisements is limited. For example,
‘‘benefit claims,’’ broadly defined,
appearing in advertisements are often
presented in general language that does
not inform patients of the likelihood of
efficacy and are often simply variants of
1 For prescription drugs and biologics, the act
requires advertisements to contain ‘‘information in
brief summary relating to side effects,
contraindications, and effectiveness’’ (21 CFR
202.1(e)(1)).
2 See Schwartz, L., S. Woloshin, W. Black, et al.,
‘‘The Role of Numeracy in Understanding the
Benefit of Screening Mammography,’’ Annals of
Internal Medicine, 127(11), 966–72, 1997.
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[Federal Register Volume 75, Number 115 (Wednesday, June 16, 2010)]
[Notices]
[Pages 34141-34142]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Vaccine Advisory Committee Meetings
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice of meetings.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the
Department of Health and Human Services (HHS) is hereby giving notice
that the National Vaccine Advisory Committee (NVAC) will hold two
teleconference meetings. The meetings are open to the public. Pre-
registration is not required, however, individuals who wish to
participate in the public comment sessions should either e-mail
nvpo@hhs.gov or call 202-690-5566 to register.
DATES: The meeting dates are:
1. July 27, 2010, 1 p.m.-2 p.m. EDT.
2. August 25, 2010, 1 p.m.-2 p.m. EDT.
ADDRESSES: The meetings will occur by teleconference. To attend, please
call 1-888-677-1385, passcode ``NVAC.''
FOR FURTHER INFORMATION CONTACT: Daniel Salmon, National Vaccine
Program Office, Department of Health and Human Services, Room 715-H,
Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington,
DC 20201. Phone: (202) 690-5566; Fax: (202) 260-1165; e-mail:
nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public
Health Service Act (42 U.S.C. Section 300aa-1), the Secretary of Health
and Human Services was mandated to establish the National Vaccine
Program to achieve optimal prevention of human infectious diseases
through immunization and to achieve optimal prevention against adverse
reactions to vaccines. The National Vaccine Advisory Committee was
established to provide advice and make recommendations to the Director
of the National Vaccine Program, on matters related to the Program's
responsibilities. The Assistant Secretary for Health serves as Director
of the National Vaccine Program.
These are special meetings of the NVAC. Discussions will focus on
the work of the Vaccine Safety Risk Assessment Working Group (VSRAWG)
and the reports that it generates. The reports will summarize the work
to-date of the H1N1 VSRAWG reviewing H1N1 safety monitoring data. These
NVAC meetings may also include topics beyond the VSRAWG such as the
[[Page 34142]]
National Vaccine Plan and updates from other Working Groups. If there
is a change in meeting dates this information will be posted on the
NVAC Web site (https://www.hhs.gov/nvpo/nvac/) as soon as the pertinent
information becomes available.
For these special meetings, members of the public are invited to
attend by teleconference via a toll-free call-in phone number. The
call-in number will be operator assisted to provide members of the
public the opportunity to provide comments to the Committee. Public
participation and ability to comment will be limited to space and time
available. Public comment will be limited to no more than three minutes
per speaker. Pre-registration is required for public comment only.
Individuals who plan to attend and need special assistance, such as
accommodation for hearing impairment or other reasonable
accommodations, should notify the designated contact person at least
one week prior to the meeting.
Any members of the public who wish to have printed material
distributed to NVAC should submit materials to the Executive Secretary,
NVAC, through the contact person listed above prior to close of
business one week before each meeting (conference call). A draft agenda
and any additional materials will be posted on the NVAC Web site
(https://www.hhs.gov/nvpo/nvac/) prior to the meeting.
Dated: June 1, 2010.
Bruce Gellin,
Deputy Assistant Secretary for Health, Director, National Vaccine
Program Office, Executive Secretary, NVAC.
[FR Doc. 2010-14472 Filed 6-15-10; 8:45 am]
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