Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program, 76628-76629 [2013-29822]
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ehiers on DSK2VPTVN1PROD with NOTICES
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Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices
Contact Person: Michelle Consolazio,
Office of the National Coordinator, HHS,
355 E Street SW., Washington, DC
20024, 781–710–0786, Fax: 202–690–
6079, email:
michelle.consolazio@hhs.gov. Please
email Michelle Consolazio for up-todate information on this meeting. 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 and updates
from ONC and other Federal agencies.
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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
https://www.healthit.gov/FACAS/healthit-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
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special accommodations are required,
please contact Michelle Consolazio at
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meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. No. 92–463, 5 U.S.C., App. 2).
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Dated: December 6, 2013.
Michelle Consolazio,
FACA Program Director, Office of Policy and
Planning, Office of the National Coordinator
for Health Information Technology.
[FR Doc. 2013–30102 Filed 12–17–13; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1204]
Draft Risk Profile on Pathogens and
Filth in Spices: Availability; Extension
of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; Extension of comment
period.
The Food and Drug
Administration (FDA or we) is
extending the comment period for the
notice entitled ‘‘Draft Risk Profile on
Pathogens and Filth in Spices:
Availability’’ that appeared in the
Federal Register of November 4, 2013
(78 FR 66010). In the notice, FDA
requested comments that can help
improve the data and information used;
the analytical analyses employed; and
the clarity and transparency of the draft
risk profile. We are taking this action in
response to a request for an extension to
allow interested persons additional time
to submit comments, scientific data, and
information.
DATES: We are extending the comment
period for the draft risk profile. Submit
either electronic or written comments
by March 3, 2014.
ADDRESSES: Submit electronic
comments and scientific data and
information to https://
www.regulations.gov. Submit written
comments and scientific data and
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jane
Van Doren, Center for Food Safety and
Applied Nutrition (HFS–06), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2927.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
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II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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, and
will be posted to the docket at https://
www.regulations.gov.
Dated: December 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–30055 Filed 12–17–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0308]
Centers for Medicare and Medicaid
Services
[CMS–3180–N3]
Pilot Program for Parallel Review of
Medical Products; Extension of the
Duration of the Program
Food and Drug
Administration, Centers for Medicare
and Medicaid Services, HHS.
ACTION: Notice.
AGENCIES:
The Food and Drug
Administration (FDA) and the Centers
for Medicare and Medicaid Services
(CMS) (the Agencies) are announcing
the extension of the ‘‘Pilot Program for
Parallel Review of Medical Products.’’
SUMMARY:
In the Federal Register of November
4, 2013 (78 FR 66010), we published a
notice entitled ‘‘Draft Risk Profile on
Pathogens and Filth in Spices:
Availability.’’ The notice provided a 60-
PO 00000
day comment period for comments that
can help improve (1) the data and
information used; (2) the analytical
analyses employed; and (3) the clarity
and transparency of the draft risk
profile.
We have received one request for an
extension of the comment period for the
notice. The request conveyed concern
that the current 60-day comment period
is not adequate to develop a response to
the notice.
We have considered the request and
are extending the comment period for
the notice for 60 days, until March 3,
2014. We believe that a 60-day
extension allows adequate time for
interested persons to submit comments,
scientific data, and information without
significantly delaying the risk profile.
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Federal Register / Vol. 78, No. 243 / Wednesday, December 18, 2013 / Notices
The Agencies have decided to continue
the program as currently designed for an
additional period of 2 years from the
date of publication of this notice.
DATES: This notice is effective December
18, 2013.
FOR FURTHER INFORMATION CONTACT: John
Burke, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5460, Silver Spring,
MD 20993–0002, 301–796–5738,
John.Burke@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of October 11, 2011 (76
FR 62808), the Agencies announced the
procedures and guiding principles for
the Parallel Review Pilot Program and
solicited nominations for the pilot. To
date, there has been significant interest
in the pilot and the Agencies are
currently working through the parallel
review process with the approved pilot
program participants. We believe that
interest in the pilot has also facilitated
mutually informative discussions
between additional sponsors and the
Agencies.
In the October 11, 2011 (76 FR 62808),
Parallel Review Pilot Program notice,
the Agencies stated their intent to
accept requests for a 2-year period,
followed by an announcement in the
Federal Register as to the future of the
pilot. The Agencies have decided to
continue the program as currently
designed for an additional 2 years from
the date of publication of this notice.
Once a representative group of
participants have completed the pilot
process the Agencies will formally
evaluate the program for best practices
and will announce any future revisions
and/or enhancements in a future
Federal Register notice.
Dated: December 5, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: December 6, 2013.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2013–29822 Filed 12–17–13; 8:45 am]
BILLING CODE 4120–01–M; 4160–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ehiers on DSK2VPTVN1PROD with NOTICES
National Institutes of Health
The National Children’s Study,
Vanguard (Pilot) Study; Submission for
OMB Review; 30-Day Comment
Request
In compliance with the
requirement of Section 3506(c)(2)(A) of
SUMMARY:
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15:27 Dec 17, 2013
Jkt 232001
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on August 23,
2013, page 52548 and allowed 60-days
for public comment. Two public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The Eunice
Kennedy Shriver, National Institute of
Child Health and Human Development
(NICHD), National Institutes of Health,
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: Desk Officer for NIH.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dr. Sarah L. Glavin, Deputy
Director, Office of Science Policy,
Analysis and Communication, Eunice
Kennedy Shriver National Institute of
Child Health and Human Development,
National Institutes of Health, 31 Center
Drive, Room 2A18, Bethesda, Maryland
20892, or call a non-toll free number
(301) 496–7898 or Email your request,
including your address to glavins@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: The National
Children’s Study, Vanguard (Pilot)
Study, 0925–0593, Expiration 8/31/
2014—Revision, Eunice Kennedy
Shriver National Institute of Child
Health and Human Development
FOR FURTHER INFORMATION CONTACT:
PO 00000
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76629
(NICHD), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of this request
is to continue data collection activities
for the NCS Vanguard Study and receive
a renewal of the Vanguard Study
clearance. The NCS also proposes the
initiation of a new enrollment cohort,
the addition of new Study visits,
revisions to existing Study visits, and
the initiation of methodological
substudies. The NCS Vanguard Study is
a prospective, longitudinal pilot study
of child health and development that
will inform the design of the Main
Study of the National Children’s Study.
Background: The National Children’s
Study is a prospective, national
longitudinal study of the interaction
between environment, genetics on child
health, and development. The Study
defines ‘‘environment’’ broadly, taking a
number of natural and man-made
environmental, biological, genetic, and
psychosocial factors into account.
Findings from the Study will be made
available as the research progresses,
making potential benefits known to the
public as soon as possible. The National
Children’s Study (NCS) has several
components, including a pilot or
Vanguard Study, and a Main Study to
collect exposure and outcome data.
The NCS Vanguard Study continues
to follow the children and families
enrolled in the Vanguard Study,
conducting Study visits in participants’
homes and over the telephone. Data
Collection visits may include the
administration of questionnaires,
neurodevelopmental assessments,
physical measures, and the collection of
biospecimens and environmental
measures. The Vanguard Study has
yielded valuable data and field
experience related to participant
recruitment, the conduct of Study
assessments, and operational
requirements associated with NCS
infrastructure and field efforts. The
purpose of the proposed data collection
is to obtain further operational and
performance data on processes and
administration Study visit measures.
Research Questions: The primary
research goal is to systematically pilot
additional study visit measures and
collections for scientific robustness,
burden to participants and study
infrastructure, and cost for use in the
Vanguard (Pilot) Study and to inform
the Main Study. A secondary goal is to
increase enrollment in the Vanguard
Study through the identification of
subsequent pregnancies among enrolled
women.
Methods: The NCS Vanguard Study
data collection schedule currently
E:\FR\FM\18DEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 243 (Wednesday, December 18, 2013)]
[Notices]
[Pages 76628-76629]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29822]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0308]
Centers for Medicare and Medicaid Services
[CMS-3180-N3]
Pilot Program for Parallel Review of Medical Products; Extension
of the Duration of the Program
AGENCIES: Food and Drug Administration, Centers for Medicare and
Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and the Centers for
Medicare and Medicaid Services (CMS) (the Agencies) are announcing the
extension of the ``Pilot Program for Parallel Review of Medical
Products.''
[[Page 76629]]
The Agencies have decided to continue the program as currently designed
for an additional period of 2 years from the date of publication of
this notice.
DATES: This notice is effective December 18, 2013.
FOR FURTHER INFORMATION CONTACT: John Burke, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5460, Silver Spring, MD 20993-0002, 301-796-5738,
John.Burke@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 11, 2011
(76 FR 62808), the Agencies announced the procedures and guiding
principles for the Parallel Review Pilot Program and solicited
nominations for the pilot. To date, there has been significant interest
in the pilot and the Agencies are currently working through the
parallel review process with the approved pilot program participants.
We believe that interest in the pilot has also facilitated mutually
informative discussions between additional sponsors and the Agencies.
In the October 11, 2011 (76 FR 62808), Parallel Review Pilot
Program notice, the Agencies stated their intent to accept requests for
a 2-year period, followed by an announcement in the Federal Register as
to the future of the pilot. The Agencies have decided to continue the
program as currently designed for an additional 2 years from the date
of publication of this notice.
Once a representative group of participants have completed the
pilot process the Agencies will formally evaluate the program for best
practices and will announce any future revisions and/or enhancements in
a future Federal Register notice.
Dated: December 5, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
Dated: December 6, 2013.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2013-29822 Filed 12-17-13; 8:45 am]
BILLING CODE 4120-01-M; 4160-01-M
