Request for Nominations of Candidates To Serve on the Advisory Committee on Immunization Practices (ACIP), 4302-4303 [2016-01443]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
4302
Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices
major health agencies within HHS—
CDC, Centers for Medicare & Medicaid
Services, FDA, Health Resources and
Services Administration, Indian Health
Service, National Institutes of Health,
National Library of Medicine, Office of
the National Coordinator for Health
Information Technology, Office of
Public Health and Science, and
Substance Abuse and Mental Health
Services Administration—as well as the
DoD and VA.
When developing Common Formats,
AHRQ first reviews existing patient
safety practices and event reporting
systems. In collaboration with the
PSWG and Federal subject matter
experts, AHRQ drafts and releases beta
versions of the Common Formats for
public review and comment. The PSWG
assists AHRQ with assuring the
consistency of definitions/formats with
those of relevant government agencies
as refinement of the Common Formats
continues.
Since the initial release of the
Common Formats in August 2008,
AHRQ has regularly revised the formats
based upon public comment. AHRQ
solicits feedback on beta (and
subsequent) versions of Common
Formats from private sector
organizations and individuals. Based
upon the feedback received, AHRQ
further revises the Common Formats. To
the extent practicable, the Common
Formats are also aligned with World
Health Organization (WHO) concepts,
frameworks, and definitions.
Participation by the private sector in
the development and subsequent
revision of the Common Formats is
achieved through working with the
NQF. The Agency engages the NQF, a
non-profit organization focused on
health care quality, to solicit comments
and advice regarding proposed versions
of the Common Formats. AHRQ began
this process with the NQF in 2008,
receiving feedback on AHRQ’s 0.1 Beta
release of the Common Formats for
Event Reporting—Hospital. After
receiving public comment, the NQF
solicits the review and advice of its
Common Formats Expert Panel and
subsequently provides feedback to
AHRQ. The Agency then revises and
refines the Common Formats and issues
them as a production version. AHRQ
has continued to employ this process for
all subsequent versions of the Common
Formats.
The technical specifications promote
standardization of collected patient
safety event information by specifying
rules for data collection and submission,
as well as by providing guidance for
how and when to create data elements,
their valid values, conditional and go-to
VerDate Sep<11>2014
21:57 Jan 25, 2016
Jkt 238001
logic, and reports. These specifications
will ensure that data collected by PSOs
and other entities have comparable
clinical meaning.
The technical specifications also
provide direction to software
developers, so that the Common
Formats can be implemented
electronically, and to PSOs, so that the
Common Formats can be submitted
electronically to the Patient Safety
Organization Privacy Protection Center
(PSOPPC) for data de-identification and
transmission to the NPSD.
Common Formats technical
specifications consist of the following:
• Data dictionary—defines data
elements and their attributes (data
element name, answer values, field
length, guide for use, etc.) included in
Common Formats;
• Clinical document architecture
(CDA) implementation guide—provides
instructions for developing a file to
transmit the Common Formats Patient
Safety data from the PSO to the PSOPPC
using the Common Formats;
• Validation rules and errors
document—specifies and defines the
validation rules that will be applied to
the Common Formats data elements
submitted to the PSOPPC;
• Common Formats flow charts—
diagrams the valid paths to complete
generic and event specific formats (a
complete event report);
• Local specifications—provides
specifications for processing, linking
and reporting on events and details
specifications for reports; and
• Metadata registry—includes
descriptive facts about information
contained in the data dictionary to
illustrate how such data corresponds
with similar data elements used by
other Federal agencies and standards
development organizations [e.g., HL—7,
International Standards Organization
(ISO)].
Agenda, Registration, and Other
Information about the Meeting
The 2016 meeting will be an
interactive forum designed to allow
meeting participants not only to provide
input but also to respond to the input
provided by others. The meeting agenda
will include: an update of Federal
efforts related to the Common Formats,
including development of formats for
new settings; Common Formats software
products demonstrations; a discussion
of data integrity related to submission of
patient safety adverse events; and a
question and answer session.
AHRQ requests that interested
persons send an email to the PSOPPC at
support@psoppc.org for registration
information. Before the meeting, a
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
detailed agenda and logistical
information will be provided to
registrants. Prior to the meeting, AHRQ
invites review of the technical
specifications for Common Formats
which can be accessed through AHRQ’s
PSO Web site at https://www.psoppc.
org/psoppc_web/publicpages/common
FormatsOverview.
Sharon B. Arnold,
AHRQ Deputy Director.
[FR Doc. 2016–01353 Filed 1–25–16; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Request for Nominations of
Candidates To Serve on the Advisory
Committee on Immunization Practices
(ACIP)
The Centers for Disease Control and
Prevention (CDC) is soliciting
nominations for membership on ACIP.
The ACIP consists of 15 experts in fields
associated with immunization, who are
selected by the Secretary of the U.S.
Department of Health and Human
Services (HHS) to provide advice and
guidance to the Secretary, the Assistant
Secretary for Health, and the CDC on the
control of vaccine-preventable diseases.
The role of the ACIP is to provide
advice that will lead to a reduction in
the incidence of vaccine preventable
diseases in the United States, and an
increase in the safe use of vaccines and
related biological products. The
committee also establishes, reviews, and
as appropriate, revises the list of
vaccines for administration to children
eligible to receive vaccines through the
Vaccines for Children (VFC) Program.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the committee’s
objectives. Nominees will be selected
based on expertise in the field of
immunization practices; multidisciplinary expertise in public health;
expertise in the use of vaccines and
immunologic agents in both clinical and
preventive medicine; knowledge of
vaccine development, evaluation, and
vaccine delivery; or knowledge about
consumer perspectives and/or social
and community aspects of
immunization programs. Federal
employees will not be considered for
membership. Members may be invited
to serve for four-year terms.
The next cycle of selection of
candidates will begin in the fall of 2016,
E:\FR\FM\26JAN1.SGM
26JAN1
Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices
for selection of potential nominees to
replace members whose terms will end
on June 30, 2017. Selection of members
is based on candidates’ qualifications to
contribute to the accomplishment of
ACIP objectives (https://www.cdc.gov/
vaccines/acip/). The U.S.
Department of Health and Human
Services policy stipulates that
committee membership be balanced in
terms of professional training and
background, points of view represented,
and the committee’s function.
Consideration is given to a broad
representation of geographic areas
within the U.S., with equitable
representation of the sexes, ethnic and
racial minorities, and persons with
disabilities. Nominees must be U.S.
citizens, and cannot be full-time
employees of the U.S. Government.
Candidates should submit the following
items:
D Current curriculum vitae, including
complete contact information
(telephone numbers, mailing address,
email address)
D At least one letter of
recommendation from person(s) not
employed by HHS *
The deadline for receipt of all
application materials (for consideration
for term beginning July 1, 2017) is
November 4, 2016. All files must be
submitted electronically as email
attachments to: Ms. Stephanie Thomas,
ACIP Secretariat, Email: SThomas5@
cdc.gov.
Nominations may be submitted by the
candidate him- or herself, or by the
person/organization recommending the
candidate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
* Candidates may submit letter(s) from
current HHS employees if they wish, but at
least one letter must be submitted by a
person not employed by HHS (e.g., CDC,
NIH, FDA, etc.).
[Docket No. FDA–2015–D–4852]
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2016–01443 Filed 1–25–16; 8:45 am]
BILLING CODE 4163–18–P
VerDate Sep<11>2014
21:57 Jan 25, 2016
Jkt 238001
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Health Statistics
(BSC, NCHS)
Notice of Cancellation: This notice
was published in the Federal Register
on December 23, 2015, Volume 80,
Number 246, pages 79899–79900. The
meeting previously scheduled to
convene on January 21–22, 2016, has
been cancelled.
Contact Person for More Information:
Virginia S. Cain, Ph.D., Director of
Extramural Research, NCHS/CDC, 3311
Toledo Road, Room 7208, Hyattsville,
Maryland 20782, Telephone (301) 458–
4395, Fax (301) 458–4020, Email:
vcain@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.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2016–01442 Filed 1–25–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Design Considerations and Premarket
Submission Recommendations for
Interoperable Medical Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Design
Considerations and Pre-market
Submission Recommendations for
Interoperable Medical Devices’’. FDA is
issuing this draft guidance to assist
industry and FDA staff in identifying
specific considerations related to the
ability of electronic medical devices to
safely and effectively exchange and use
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
4303
exchanged information. This document
highlights considerations that should be
included in the development and design
of interoperable medical devices and
provides recommendations for the
content of premarket submissions and
labeling for such devices. This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by March 28,
2016.
ADDRESSES: You may submit comments
as follows:
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://
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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’’.
E:\FR\FM\26JAN1.SGM
26JAN1
]]>Agencies
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4302-4303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01443]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Request for Nominations of Candidates To Serve on the Advisory
Committee on Immunization Practices (ACIP)
The Centers for Disease Control and Prevention (CDC) is soliciting
nominations for membership on ACIP. The ACIP consists of 15 experts in
fields associated with immunization, who are selected by the Secretary
of the U.S. Department of Health and Human Services (HHS) to provide
advice and guidance to the Secretary, the Assistant Secretary for
Health, and the CDC on the control of vaccine-preventable diseases. The
role of the ACIP is to provide advice that will lead to a reduction in
the incidence of vaccine preventable diseases in the United States, and
an increase in the safe use of vaccines and related biological
products. The committee also establishes, reviews, and as appropriate,
revises the list of vaccines for administration to children eligible to
receive vaccines through the Vaccines for Children (VFC) Program.
Nominations are being sought for individuals who have expertise and
qualifications necessary to contribute to the accomplishments of the
committee's objectives. Nominees will be selected based on expertise in
the field of immunization practices; multi-disciplinary expertise in
public health; expertise in the use of vaccines and immunologic agents
in both clinical and preventive medicine; knowledge of vaccine
development, evaluation, and vaccine delivery; or knowledge about
consumer perspectives and/or social and community aspects of
immunization programs. Federal employees will not be considered for
membership. Members may be invited to serve for four-year terms.
The next cycle of selection of candidates will begin in the fall of
2016,
[[Page 4303]]
for selection of potential nominees to replace members whose terms will
end on June 30, 2017. Selection of members is based on candidates'
qualifications to contribute to the accomplishment of ACIP objectives
(https://www.cdc.gov/vaccines/acip/). The U.S. Department of
Health and Human Services policy stipulates that committee membership
be balanced in terms of professional training and background, points of
view represented, and the committee's function. Consideration is given
to a broad representation of geographic areas within the U.S., with
equitable representation of the sexes, ethnic and racial minorities,
and persons with disabilities. Nominees must be U.S. citizens, and
cannot be full-time employees of the U.S. Government. Candidates should
submit the following items:
[ssquf] Current curriculum vitae, including complete contact
information (telephone numbers, mailing address, email address)
[ssquf] At least one letter of recommendation from person(s) not
employed by HHS *
The deadline for receipt of all application materials (for
consideration for term beginning July 1, 2017) is November 4, 2016. All
files must be submitted electronically as email attachments to: Ms.
Stephanie Thomas, ACIP Secretariat, Email: SThomas5@cdc.gov.
Nominations may be submitted by the candidate him- or herself, or
by the person/organization recommending the candidate.
* Candidates may submit letter(s) from current HHS employees if
they wish, but at least one letter must be submitted by a person not
employed by HHS (e.g., CDC, NIH, FDA, etc.).
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.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2016-01443 Filed 1-25-16; 8:45 am]
BILLING CODE 4163-18-P
