Public Health Information Network (PHIN) Messaging Guide for Syndromic Surveillance, 25695-25696 [2011-10949]
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Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Notices
well as updates from approximately half
of the NORA Sector Councils on their
progress, priorities, and implementation
plans to date, including the NORA
Manufacturing, Public Safety, Services,
and Wholesale and Retail Trade Sector
Councils. Updates will also be given on
the Mid-Decade Review of NORA, the
NORA Symposium 2011, and at least
one NIOSH Program that is working on
several NORA priorities, e.g., the NIOSH
Economics Program. After each update,
there will be time to discuss partnership
opportunities.
Status: The meeting is open to the
public, limited only by the capacities of
the conference call and conference room
facilities. There is limited space
available in the meeting room (capacity
34). Therefore, information to allow
participation in the meeting through the
Internet (to see the slides) and a
teleconference call (capacity 50) will be
provided to registered participants.
Participants are encouraged to consider
attending by this method. Each
participant is requested to register for
the free meeting by sending an e-mail to
noracoordinator@cdc.gov containing the
participant’s name, organization name,
contact telephone number on the day of
the meeting, and preference for
participation by Web meeting
(requirements include: Computer,
Internet connection, and telephone,
preferably with ‘mute’ capability) or in
person. An e-mail confirming
registration will include the details
needed to participate in the Web
meeting. Non-U.S. citizens are
encouraged to participate in the Web
meeting. Non-U.S. citizens who do not
register to attend in person on or before
June 6, 2011, will not be granted access
to the meeting site and will not be able
to attend the meeting in-person due to
mandatory security clearance
procedures at the Patriots Plaza facility.
Background: NORA is a partnership
program to stimulate innovative
research in occupational safety and
health leading to improved workplace
practices. Unveiled in 1996, NORA has
become a research framework for the
nation. Diverse parties collaborate to
identify the most critical issues in
workplace safety and health. Partners
then work together to develop goals and
objectives for addressing those needs
and to move the research results into
practice. The NIOSH role is facilitator of
the process. For more information about
NORA, see https://www.cdc.gov/niosh/
nora/about.html.
Since 2006, NORA has been
structured according to industrial
sectors. Ten major sector groups have
been defined using the North American
Industrial Classification System
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(NAICS). After receiving public input
through the Web and town hall
meetings, ten NORA Sector Councils
have been working to define sectorspecific strategic plans for conducting
research and moving the results into
widespread practice. During 2008–10,
most of these Councils posted draft
strategic plans for public comment and
eight have posted finalized National
Sector Agendas after considering
comments on the drafts. For the
National Sector Agendas, see https://
www.cdc.gov/niosh/nora/.
FOR FURTHER INFORMATION CONTACT:
Sidney C. Soderholm, PhD, NORA
Coordinator, e-mail
noracoordinator@cdc.gov, telephone
(202) 245–0665.
Dated: April 27, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–10950 Filed 5–4–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2011–0004]
Public Health Information Network
(PHIN) Messaging Guide for Syndromic
Surveillance
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS) is requesting
public comment on the draft PHIN
Messaging Guide for Syndromic
Surveillance. The document translates
the business requirement
recommendations from the International
Society for Disease Surveillance to
technical specifications to support
meaningful use of electronic health
records for syndromic surveillance.
Comments will be used to inform and
finalize the Messaging Guide.
DATES: Written comments must be
received on or before June 20, 2011. See
Addresses for instructions to submit
comment.
ADDRESSES: You may submit written
comments to the following address:
Public Health Informatics and
Technology Program Office, Centers for
Disease Control and Prevention, 1600
Clifton Road, NE., Mailstop E–76,
SUMMARY:
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25695
Atlanta, Georgia 30329. Attn: PHIN
Syndromic Surveillance Messaging
Guide Comments (Docket No. CDC–
2011–0004),
You may also submit written
comments electronically to https://
www.regulations.gov. Comments must
be identified by Docket No. CDC–2011–
0004. Please follow directions at https://
wwww.regulations.gov to submit
comments.
All relevant comments received will
be posted publicly without change,
including any personal or proprietary
information provided. An electronic
version of the draft is available to
download at https://www.regulations.gov
and https://www.cdc.gov/phin/library/
2011/guides/Syndromic_
Surveillance_Implementation_
Guide_Release_1_4.pdf.
Written comments, identified by
Docket No. CDC–2011–0004, will be
available for public inspection Monday
through Friday, except for legal
holidays, from 9 a.m. until 5 p.m.,
Eastern Daylight Time, at 1600 Clifton
Road, NE., Atlanta, Georgia 30333.
Please call ahead to (404) 639–6100 and
ask for a representative from the Public
Health Informatics and Technology
Program Office to schedule your visit.
Comments may also be viewed at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Nikolay Lipskiy, Centers for Disease
Control and Prevention, Public Health
Informatics and Technology Program
Office; l600 Clifton Road, NE., Mailstop
E–76, Atlanta, Georgia 30329, phone
404–498–6100.
SUPPLEMENTARY INFORMATION: The
International Society for Disease
Surveillance (ISDS), with the support of
CDC, convened a Meaningful Use
Workgroup to define current syndromic
surveillance business standards and
data requirements. The goal of the ISDS
workgroup is to ensure that public
health authorities, health care
professionals, Electronic Health Record
(EHR) technology developers, and the
HHS Office of the National Coordinator
for Health Information Technology have
business standards that will best
support meaningful use of EHRs for
syndromic surveillance. The Final
Recommendation from ISDS (available
at https://www.syndromic.org/uploads/
files/ISDSRecommendation_FINAL.pdf)
was published in early January 2011. As
the ISDS workgroup developed
recommendations, the CDC Public
Health Informatics and Technology
Program Office, worked to translate the
business requirement recommendations
to technical specifications. This notice
announces a draft PHIN Messaging
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[FR Doc. 2011–10949 Filed 5–4–11; 8:45 am]
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Spencer Salis, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Building 51, rm. 5216,
Silver Spring, MD 20993–0002, 301–
796–3327.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4163–18–P
I. Background
Guide for Syndromic Surveillance
available for public comment at https://
www.regulations.gov and https://
www.cdc.gov/phin/library/2011/guides/
Syndromic_Surveillance_
Implementation_Guide_Release_1_4.pdf
Dated: April 27, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0322]
Guidance for Industry on Dosage
Delivery Devices for Orally Ingested
OTC Liquid Drug Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Dosage Delivery Devices for
Orally Ingested OTC Liquid Drug
Products.’’ This document is intended to
provide guidance to firms that are
manufacturing, marketing, or
distributing orally ingested over-thecounter (OTC) liquid drug products
packaged with dosage delivery devices
(e.g., calibrated cups, droppers,
syringes, or spoons). FDA is issuing this
guidance because of ongoing concerns
about potentially serious accidental
drug overdoses that can result from the
use of dosage delivery devices with
markings that are inconsistent or
incompatible with the labeled dosage
directions for orally ingested OTC liquid
drug products.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
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FDA is announcing the availability of
a guidance for industry entitled ‘‘Dosage
Delivery Devices for Orally Ingested
OTC Liquid Drug Products.’’ The
Agency has determined that many orally
ingested OTC liquid drug products in
the marketplace are packaged with
dosage delivery devices that bear
markings that are inconsistent with the
labeled dosage directions, contain
superfluous markings, or are missing
necessary markings. FDA is issuing this
guidance because of ongoing concerns
about potentially serious accidental
drug overdoses that can result from the
use of dosage delivery devices with
markings that are inconsistent or
incompatible with the labeled dosage
directions for orally ingested OTC drug
products. FDA recommends that dosage
delivery devices be included for all
orally ingested OTC drug products that
are liquid formulations, that they should
bear markings that are consistent with
the labeled dosage directions, and that
they should be labeled in a manner that
attempts to ensure that they are used
only with the products with which they
are included.
In the Federal Register of November
5, 2009 (74 FR 57319), FDA announced
the availability of a draft guidance for
industry entitled ‘‘Dosage Delivery
Devices for Over-the-Counter Liquid
Drug Products.’’ The notice gave
interested persons an opportunity to
comment by February 2, 2010. We
received a number of comments from
individuals, firms, and consumer
groups. We have carefully considered
the comments and, where appropriate,
have made corrections, added
information, or clarified the information
in the guidance in response to the
comments or on our own initiative.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on dosage delivery
devices for orally ingested OTC liquid
drug products. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
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used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–10965 Filed 5–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
that the following committee will
convene its sixty-seventh meeting.
Name: National Advisory Committee on
Rural Health and Human Services.
Dates and Times: June 15, 2011, 9 a.m.–
4:45 p.m., June 16, 2011, 9 a.m.–4:45 p.m.,
June 17, 2011, 8:45 a.m.–10:30 a.m.
Place: Park Place Hotel, 300 East State
Street, Traverse City, MI 49684. (231) 946–
5000.
Status: The meeting will be open to the
public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations of health and human
services in rural areas.
Agenda: Wednesday morning, at 9 a.m.,
the meeting will be called to order by the
Chairperson of the Committee, the Honorable
Ronnie Musgrove. The first three
presentations will be overviews of rural
Michigan and the relevant health indicators.
The remainder of the day the Committee will
hear presentations on two of the chosen
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Agencies
[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25695-25696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10949]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2011-0004]
Public Health Information Network (PHIN) Messaging Guide for
Syndromic Surveillance
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), located
within the Department of Health and Human Services (HHS) is requesting
public comment on the draft PHIN Messaging Guide for Syndromic
Surveillance. The document translates the business requirement
recommendations from the International Society for Disease Surveillance
to technical specifications to support meaningful use of electronic
health records for syndromic surveillance. Comments will be used to
inform and finalize the Messaging Guide.
DATES: Written comments must be received on or before June 20, 2011.
See Addresses for instructions to submit comment.
ADDRESSES: You may submit written comments to the following address:
Public Health Informatics and Technology Program Office, Centers for
Disease Control and Prevention, 1600 Clifton Road, NE., Mailstop E-76,
Atlanta, Georgia 30329. Attn: PHIN Syndromic Surveillance Messaging
Guide Comments (Docket No. CDC-2011-0004),
You may also submit written comments electronically to https://www.regulations.gov. Comments must be identified by Docket No. CDC-
2011-0004. Please follow directions at https://wwww.regulations.gov to
submit comments.
All relevant comments received will be posted publicly without
change, including any personal or proprietary information provided. An
electronic version of the draft is available to download at https://www.regulations.gov and https://www.cdc.gov/phin/library/2011/guides/Syndromic_Surveillance_Implementation_Guide_Release_1_4.pdf.
Written comments, identified by Docket No. CDC-2011-0004, will be
available for public inspection Monday through Friday, except for legal
holidays, from 9 a.m. until 5 p.m., Eastern Daylight Time, at 1600
Clifton Road, NE., Atlanta, Georgia 30333. Please call ahead to (404)
639-6100 and ask for a representative from the Public Health
Informatics and Technology Program Office to schedule your visit.
Comments may also be viewed at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Nikolay Lipskiy, Centers for Disease
Control and Prevention, Public Health Informatics and Technology
Program Office; l600 Clifton Road, NE., Mailstop E-76, Atlanta, Georgia
30329, phone 404-498-6100.
SUPPLEMENTARY INFORMATION: The International Society for Disease
Surveillance (ISDS), with the support of CDC, convened a Meaningful Use
Workgroup to define current syndromic surveillance business standards
and data requirements. The goal of the ISDS workgroup is to ensure that
public health authorities, health care professionals, Electronic Health
Record (EHR) technology developers, and the HHS Office of the National
Coordinator for Health Information Technology have business standards
that will best support meaningful use of EHRs for syndromic
surveillance. The Final Recommendation from ISDS (available at https://www.syndromic.org/uploads/files/ISDSRecommendation_FINAL.pdf) was
published in early January 2011. As the ISDS workgroup developed
recommendations, the CDC Public Health Informatics and Technology
Program Office, worked to translate the business requirement
recommendations to technical specifications. This notice announces a
draft PHIN Messaging
[[Page 25696]]
Guide for Syndromic Surveillance available for public comment at https://www.regulations.gov and https://www.cdc.gov/phin/library/2011/guides/Syndromic_Surveillance_Implementation_Guide_Release_1_4.pdf
Dated: April 27, 2011.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2011-10949 Filed 5-4-11; 8:45 am]
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