81 FR 79035 - Health IT Standards Committee Advisory Meeting; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 81, Issue 218 (November 10, 2016)
Federal Register Volume 81, Issue 218 (November 10, 2016)
| Page Range | 79035-79036 | |
| FR Document | 2016-27172 |
[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)] [Notices] [Pages 79035-79036] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27172] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health IT Standards Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting ----------------------------------------------------------------------- This notice announces updated dates for meetings of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). These meetings are open to the public. Name of Committee: Health IT Standards Committee. General Function of the Committee: To provide recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. 2016 Meeting Dates and TimesDecember 6, 2016 from 9:30 a.m. to 1:30 p.m./Eastern Time (replacing the formerly announced November 2 and December 7 meetings) [cir] This will be a virtual Joint Health IT Policy and Health IT Standards Committee meeting For meeting locations, web conference information, and the most up- to-date information, please visit the calendar on the ONC Web site, http://www.healthit.gov/FACAS/calendar. Contact Person: Michelle Consolazio, email: [email protected]. Please email Michelle Consolazio for the most current information about meetings. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Agenda: The committee will hear reports from its workgroups/task forces and updates from ONC and other federal agencies. ONC intends to make background material available to the public no later than 24 hours prior to the meeting start time. If ONC is unable to post the background material on its Web site prior to the meeting, it will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on ONC's Web site after the meeting, at http://www.healthit.gov/facas/health-it-standards-committee. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions may be made to the contact person prior to the meeting date. Oral comments from the public will be scheduled prior to the lunch break and at the conclusion of each 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. Persons attending ONC's advisory committee meetings are advised that the agency is not responsible for providing wireless access or access to electrical outlets. ONC welcomes the attendance of the public at its advisory committee meetings. Seating is limited at the location, and ONC will make every effort to accommodate persons with [[Page 79036]] physical disabilities or special needs. If you require special accommodations due to a disability, please contact Michelle Consolazio at least seven (7) days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App. 2). Dated: October 31, 2016. Michelle Consolazio, FACA Program Director, Office of Policy, Office of the National Coordinator for Health Information Technology. [FR Doc. 2016-27172 Filed 11-9-16; 8:45 am] BILLING CODE 4150-45-P
![Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Notices 79035
Hampshire Ave., Bldg. 71, Rm. 7301, Reduce the Risk of Transmission of with the implementation of the Federal
Silver Spring, MD 20993–0002, 240– Trypanosoma cruzi Infection in Whole Health IT Strategic Plan, and in
402–7911. Blood and Blood Components Intended accordance with policies developed by
SUPPLEMENTARY INFORMATION: for Transfusion; Draft Guidance for the Health IT Policy Committee.
Industry.’’ It does not establish any 2016 Meeting Dates and Times
I. Background rights for any person and is not binding
FDA is announcing the availability of on FDA or the public. You can use an • December 6, 2016 from 9:30 a.m. to
a draft document entitled ‘‘Amendment alternative approach if it satisfies the 1:30 p.m./Eastern Time (replacing
to Guidance for Industry: Use of requirements of the applicable statutes the formerly announced November
Serological Tests to Reduce the Risk of and regulations. 2 and December 7 meetings)
Transmission of Trypanosoma cruzi Æ This will be a virtual Joint Health
Infection in Whole Blood and Blood II. Paperwork Reduction Act of 1995 IT Policy and Health IT Standards
Components Intended for Transfusion; This draft guidance refers to Committee meeting
Draft Guidance for Industry.’’ The draft previously approved collections of For meeting locations, web conference
guidance, when finalized, is intended to information found in FDA regulations. information, and the most up-to-date
amend the 2010 Chagas Guidance (75 These collections of information are information, please visit the calendar on
FR 75810, December 6, 2010) by subject to review by the Office of the ONC Web site, http://
expanding the scope of the guidance to Management and Budget (OMB) under www.healthit.gov/FACAS/calendar.
include the collection of blood and the Paperwork Reduction Act of 1995 Contact Person: Michelle Consolazio,
blood components for use in (44 U.S.C. 3501–3520). The collections email: michelle.consolazio@hhs.gov.
manufacturing a product, including of information in 21 CFR 601.12 have Please email Michelle Consolazio for the
donations intended as a component of, been approved under OMB control most current information about
or used to manufacture, a medical number 0910–0338; and the collections meetings. A notice in the Federal
device; removing the recommendation of information in 21 CFR 610.40 and Register about last minute modifications
to ask donors about a history of Chagas 630.40 have been approved under OMB that impact a previously announced
disease; and providing a control numbers 0910–0116 and 0910– advisory committee meeting cannot
recommendation for a reentry algorithm 0795. always be published quickly enough to
for donors deferred on the basis of provide timely notice.
screening test results for antibodies to T. III. Electronic Access Agenda: The committee will hear
cruzi or on the basis of answering ‘‘yes’’ Persons with access to the Internet reports from its workgroups/task forces
to the Chagas screening question. may obtain the draft guidance at either and updates from ONC and other federal
In the Federal Register of May 22, http://www.fda.gov/BiologicsBlood agencies. ONC intends to make
2015 (80 FR 29842), FDA published the Vaccines/Guidance background material available to the
final rule entitled ‘‘Requirements for ComplianceRegulatoryInformation/ public no later than 24 hours prior to
Blood and Blood Components Intended Guidances/default.htm or http:// the meeting start time. If ONC is unable
for Transfusion or for Further www.regulations.gov. to post the background material on its
Manufacturing Use.’’ The final rule Web site prior to the meeting, it will be
Dated: November 3, 2016.
became effective May 23, 2016. The made publicly available at the location
Leslie Kux, of the advisory committee meeting, and
draft guidance is intended to notify
blood establishments that collect blood Associate Commissioner for Policy. the background material will be posted
and blood components that T. cruzi is [FR Doc. 2016–27107 Filed 11–9–16; 8:45 am] on ONC’s Web site after the meeting, at
defined as a relevant transfusion- BILLING CODE 4164–01–P http://www.healthit.gov/facas/health-it-
transmitted infection in 21 CFR standards-committee.
630.3(h)(1), subject to the testing Procedure: Interested persons may
requirements in 21 CFR 610.40, the DEPARTMENT OF HEALTH AND present data, information, or views,
donor deferral practices in 21 CFR HUMAN SERVICES orally or in writing, on issues pending
610.41, and the donor notification before the Committee. Written
requirements in 21 CFR 630.40 under Health IT Standards Committee submissions may be made to the contact
the final rule. In addition, the draft Advisory Meeting; Notice of Meeting person prior to the meeting date. Oral
guidance is intended to notify blood AGENCY: Office of the National comments from the public will be
establishments that collect blood and Coordinator for Health Information scheduled prior to the lunch break and
blood components that FDA has Technology, HHS. at the conclusion of each meeting. Time
licensed a supplemental test for ACTION: Notice of meeting allotted for each presentation will be
antibodies to T. cruzi and further testing limited to three minutes. If the number
of donations found repeatedly reactive This notice announces updated dates of speakers requesting to comment is
to a screening test for T. cruzi is for meetings of a public advisory greater than can be reasonably
therefore required under 21 CFR committee of the Office of the National accommodated during the scheduled
610.40(e). The draft guidance does not Coordinator for Health Information open public session, ONC will take
apply to the collection of Source Technology (ONC). These meetings are written comments after the meeting.
Plasma. All other recommendations in open to the public. Persons attending ONC’s advisory
Name of Committee: Health IT committee meetings are advised that the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the 2010 Chagas Guidance would
remain unchanged. Standards Committee. agency is not responsible for providing
This draft guidance is being issued General Function of the Committee: wireless access or access to electrical
consistent with FDA’s good guidance To provide recommendations to the outlets.
practices regulation (21 CFR 10.115). National Coordinator on standards, ONC welcomes the attendance of the
The draft guidance, when finalized, will implementation specifications, and public at its advisory committee
represent the current thinking of FDA certification criteria for the electronic meetings. Seating is limited at the
on ‘‘Amendment to Guidance for exchange and use of health information location, and ONC will make every
Industry: Use of Serological Tests to for purposes of adoption, consistent effort to accommodate persons with
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![79036 Federal Register / Vol. 81, No. 218 / Thursday, November 10, 2016 / Notices
physical disabilities or special needs. If Register about last minute modifications DEPARTMENT OF HEALTH AND
you require special accommodations that impact a previously announced HUMAN SERVICES
due to a disability, please contact advisory committee meeting cannot
Michelle Consolazio at least seven (7) always be published quickly enough to National Institutes of Health
days in advance of the meeting. provide timely notice.
Notice of this meeting is given under National Institute of Environmental
Agenda: The committee will hear Health Sciences; Notice of Closed
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2). reports from its task forces and updates Meetings
from ONC and other federal agencies.
Dated: October 31, 2016. ONC intends to make background Pursuant to section 10(d) of the
Michelle Consolazio, material available to the public no later Federal Advisory Committee Act, as
FACA Program Director, Office of Policy, amended (5 U.S.C. App.), notice is
than 24 hours prior to the meeting start
Office of the National Coordinator for Health hereby given of the following meetings.
time. If ONC is unable to post the The meetings will be closed to the
Information Technology.
background material on its Web site public in accordance with the
[FR Doc. 2016–27172 Filed 11–9–16; 8:45 am]
prior to the meeting, it will be made provisions set forth in sections
BILLING CODE 4150–45–P
publicly available at the location of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
advisory committee meeting, and the as amended. The grant applications and
DEPARTMENT OF HEALTH AND background material will be posted on the discussions could disclose
HUMAN SERVICES ONC’s Web site after the meeting, at confidential trade secrets or commercial
http://www.healthit.gov/FACAS/health- property such as patentable material,
Health IT Policy Committee Advisory it-policy-committee. and personal information concerning
Meeting; Notice of Meeting Procedure: Interested persons may individuals associated with the grant
present data, information, or views, applications, the disclosure of which
AGENCY: Office of the National
orally or in writing, on issues pending would constitute a clearly unwarranted
Coordinator for Health Information
before the Committee. Written invasion of personal privacy.
Technology, HHS.
ACTION: Notice of meeting. submissions may be made to the contact Name of Committee: National Institute of
person prior to the meeting date. Oral Environmental Health Sciences Special,
This notice announces updated dates Emphasis Panel; E-Learning Review Meeting.
comments from the public will be
for meetings of a public advisory Date: November 29, 2016.
scheduled prior to the lunch break and Time: 11:30 a.m. to 4:00 p.m.
committee of the Office of the National at the conclusion of each meeting. Time Agenda: To review and evaluate grant
Coordinator for Health Information allotted for each presentation will be applications.
Technology (ONC). These meetings are limited to three minutes. If the number Place: NIEHS/National Institutes of Health,
open to the public. of speakers requesting to comment is Keystone Building, Room 2128, 530 Davis
Name of Committee: Health IT Policy Drive, Research Triangle Park, NC 27709
greater than can be reasonably
Committee. (Telephone Conference Call).
accommodated during the scheduled
General Function of the Committee: Contact Person: Janice B. Allen, Ph.D.,
To provide recommendations to the open public session, ONC will take Scientific Review Officer, Scientific Review
National Coordinator on a policy written comments after the meeting. Branch, Division of Extramural Research and
framework for the development and Persons attending ONC’s advisory Training, Nat. Institute of Environmental
Health Science, P.O. Box 12233, MD EC–30/
adoption of a nationwide health committee meetings are advised that the
Room 3170 B, Research Triangle Park, NC
information technology infrastructure agency is not responsible for providing 27709, 919/541–7556.
that permits the electronic exchange and wireless access or access to electrical Name of Committee: National Institute of
use of health information as is outlets. Environmental Health Sciences Special
consistent with the Federal Health IT ONC welcomes the attendance of the Emphasis Panel; R13 Conference Grant
Strategic Plan and that includes Applications Review Meeting Group 1.
public at its advisory committee
recommendations on the areas in which Date: November 30, 2016.
meetings. Seating is limited at the
standards, implementation Time: 11:30 a.m. to 4:00 p.m.
location, and ONC will make every Agenda: To review and evaluate grant
specifications, and certification criteria
are needed. effort to accommodate persons with applications.
physical disabilities or special needs. If Place: NIEHS/National Institutes of Health,
2016 Meeting Dates and Times you require special accommodations Keystone Building, Room 2128, 530 Davis
• November 3, 2016 from 9:30 a.m. to due to a disability, please contact Drive, Research Triangle Park, NC 27709
Michelle Consolazio at least seven (7) (Telephone Conference Call).
3:00 p.m./Eastern Time (Cancelled) Contact Person: Janice B. Allen, Ph.D.,
• December 6, 2016 from 9:30 a.m. to days in advance of the meeting. Scientific Review Officer, Scientific Review
1:30 p.m./Eastern Time Notice of this meeting is given under Branch, Division of Extramural Research and
Æ This will be a virtual Joint Health the Federal Advisory Committee Act Training, Nat. Institute of Environmental
IT Policy and Health IT Standards (Pub. L. 92–463, 5 U.S.C., App. 2). Health Science, P.O. Box 12233, MD EC–30/
Committee meeting Room 3170 B Research Triangle Park, NC
For meeting locations, web conference Dated: October 31, 2016. 27709, 919/541–7556.
information, and the most up-to-date Michelle Consolazio, (Catalogue of Federal Domestic Assistance
asabaliauskas on DSK3SPTVN1PROD with NOTICES
information, please visit the calendar on FACA Program Director, Office of Policy, Program Nos. 93.115, Biometry and Risk
the ONC Web site, http:// Office of the National Coordinator for Health Estimation—Health Risks from
Information Technology. Environmental Exposures; 93.142, NIEHS
www.healthit.gov/FACAS/calendar.
Hazardous Waste Worker Health and Safety
Contact Person: Michelle Consolazio, [FR Doc. 2016–27174 Filed 11–9–16; 8:45 am]
Training; 93.143, NIEHS Superfund
email: michelle.consolazio@hhs.gov. BILLING CODE 4150–45–P Hazardous Substances—Basic Research and
Please email Michelle Consolazio for the Education; 93.894, Resources and Manpower
most current information about Development in the Environmental Health
meetings. A notice in the Federal Sciences; 93.113, Biological Response to
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Document Created: 2016-11-10 01:43:53
Document Modified: 2016-11-10 01:43:53
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting | |
| FR Citation | 81 FR 79035 |
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