Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction, 81233-81234 [2015-32686]
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jstallworth on DSK7TPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Proposed Rules
device use may be associated with:
disorientation, confusion, and memory
problems.’’
(J) Absent performance data
demonstrating a beneficial effect of
longer term use, generally considered
treatment in excess of 3 months, the
following statement, prominently
placed: ‘‘Warning: When used as
intended this device provides shortterm relief of symptoms. The long-term
safety and effectiveness of ECT
treatment has not been demonstrated.’’
(ix) Patient labeling must be provided
and include:
(A) Relevant contraindications,
warnings, precautions.
(B) A summation of the clinical
testing, which includes the clinical
outcomes associated with the use of the
device, and a summary of adverse
events and complications that occurred
with the device.
(C) Information on how the device
operates and the typical course of
treatment.
(D) The potential benefits.
(E) Alternative treatments.
(F) The following statement,
prominently placed: ‘‘Warning: ECT
device use may be associated with:
disorientation, confusion, and memory
problems.’’
(G) Absent performance data
demonstrating a beneficial effect of
longer term use, generally considered
treatment in excess of 3 months, the
following statement, prominently
placed: ‘‘Warning: When used as
intended this device provides shortterm relief of symptoms. The long-term
safety and effectiveness of ECT
treatment has not been demonstrated.’’
(H) The following statements on
known risks of ECT, absent performance
data demonstrating that these risks do
not apply:
(1) ECT treatment may be associated
with disorientation, confusion and
memory loss, including short-term
(anterograde) and long-term
(autobiographical) memory loss
following treatment. These side effects
tend to go away within a few days to a
few months after the last treatment with
ECT. However, some patients have
reported a permanent loss of memories
of personal life events (i.e.,
autobiographical memory).
Improvements in the way ECT is
applied to patients currently, with
controlled electric currents and
electrode placement, can minimize but
not completely eliminate, these risks.
(2) Patients treated with ECT may also
experience manic symptoms (including
euphoria and/or irritability, impulsivity,
racing thoughts, distractibility,
grandiosity, increased activity,
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talkativeness, and decreased need for
sleep) or a worsening of the psychiatric
symptoms they are being treated for.
(3) The physical risks of ECT may
include the following (in order of
frequency of occurrence):
(i) Pain/somatic discomfort (including
headache, muscle soreness, and nausea).
(ii) Skin burns.
(iii) Physical trauma (including
fractures, contusions, injury from falls,
dental and oral injury).
(iv) Prolonged or delayed onset
seizures.
(v) Pulmonary complications
(insufficient, or lack of breathing, or
inhalation of foreign substance into the
lungs).
(vi) Cardiovascular complications
(heart attack, high or low blood
pressure, and stroke).
(vii) Death.
(viii) Devices marketed prior to the
effective date of this reclassification
must have an amendment submitted to
their previously cleared premarket
notification (510(k)) that demonstrates
compliance with these special controls
within 60 days after the effective date of
this reclassification.
(2) Classification: Class III (premarket
approval) for the following intended
uses: schizophrenia, bipolar manic
states, schizoaffective disorder,
schizophreniform disorder, and
catatonia.
(c) Date premarket approval
application (PMA) or notice of
completion of product development
protocol (PDP) is required. A PMA or
notice of completion of a PDP is
required to be filed with the Food and
Drug Administration on or before [A
DATE WILL BE ADDED 90 DAYS
AFTER DATE OF PUBLICATION OF A
FUTURE FINAL ORDER IN THE
Federal Register], for any
electroconvulsive therapy device with
an intended use described in paragraph
(b)(2) of this section, that was in
commercial distribution before May 28,
1976, or that has, on or before [A DATE
WILL BE ADDED 90 DAYS AFTER
DATE OF PUBLICATION OF A
FUTURE FINAL ORDER IN THE
Federal Register], been found to be
substantially equivalent to any
electroconvulsive therapy device with
an intended use described in paragraph
(b)(2) of this section, that was in
commercial distribution before May 28,
1976. Any other electroconvulsive
therapy device with an intended use
described in paragraph (b)(2) of this
section shall have an approved PMA or
declared completed PDP in effect before
being placed in commercial
distribution.
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Dated: December 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32592 Filed 12–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. FDA–2015–D–3719]
Draft Guidances Relating to the
Regulation of Human Cells, Tissues, or
Cellular or Tissue-Based Products;
Public Hearing; Request for
Comments; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments; correction.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
correcting a notification of a public
hearing entitled ‘‘Draft Guidances
Relating to the Regulation of Human
Cells, Tissues, or Cellular or TissueBased Products; Public Hearing; Request
for Comments’’ that appeared in the
Federal Register of October 30, 2015 (80
FR 66845). The document announced a
public hearing to obtain input on four
recently issued draft guidances relating
to the regulation of human cells, tissues,
or cellular or tissue-based products
(HCT/Ps). The document published
with conflicting information about who
must register for the public hearing.
This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lori
Jo Churchyard, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUMMARY:
In FR Doc.
2015–27703, appearing on pages 66845
and 66847 in the Federal Register of
Friday, October 30, 2015, the following
corrections are made:
1. On page 66845, in the third column
under DATES, the third sentence is
revised to read: ‘‘Persons seeking to
attend (including FDA employees) or to
present at the public hearing must
register by January 8, 2016.’’
2. On page 66847, in the first column
under section IV. Attendance and
Registration, the third sentence is
revised to read: ‘‘Individuals who wish
to attend (including FDA employees) or
present at the public hearing must
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Proposed Rules
register by sending an email to
CBERPublicEvents@fda.hhs.gov on or
before January 8, 2016, and provide
complete contact information, including
name, title, affiliation, address, email,
and phone number.’’
Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–32686 Filed 12–28–15; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 51, 52, 55, 70, 71 and 124
[EPA–HQ–OAR–2015–0090, FRL–9937–21–
OAR]
RIN 2060–AS59
Revisions to the Public Notice
Provisions in Clean Air Act Permitting
Programs
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) proposes to
revise the public notice rule provisions
for the New Source Review (NSR), title
V and Outer Continental Shelf (OCS)
permit programs of the Clean Air Act
(CAA) and the corresponding onshore
area (COA) determinations for
implementation of the OCS air quality
regulations. This action would remove
the mandatory requirement to provide
public notice of a draft air permit, as
well as certain other program actions,
through publication in a newspaper and
would instead allow for electronic
noticing (e-notice) of these actions. The
proposed rule revisions would apply to
major source air permits issued by the
EPA, by EPA-delegated air agencies, and
by air agencies with EPA-approved
programs (with the exception of permits
that are issued pursuant to the Tribal
NSR Rule, which already allows for enotice methods).
DATES: Comments. Comments must be
received on or before February 29, 2016.
Public hearing. If anyone contacts us
requesting a public hearing on or before
January 13, 2016, we will hold a
hearing. Additional information about
the hearing, if requested, will be
published in a subsequent Federal
Register document.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
OAR–2015–0090, at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
jstallworth on DSK7TPTVN1PROD with PROPOSALS
SUMMARY:
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Once submitted, comments cannot be
edited or removed from Regulations.gov.
The EPA may publish any comment
received to its public docket. Do not
submit electronically any information
you consider to be Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. The EPA will generally not
consider comments or comment
contents located outside of the primary
submission (i.e., on the Web, Cloud, or
other file sharing system). For
additional submission methods, the full
EPA public comment policy,
information about CBI or multimedia
submissions, and general guidance on
making effective comments, please visit
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: For
general information on this proposed
rule for NSR and OCS programs, please
contact Mr. Dave Svendsgaard, Office of
Air Quality Planning and Standards,
U.S. Environmental Protection Agency,
by phone at (919) 541–2380 or by email
at svendsgaard.dave@epa.gov; for title V
programs please contact Ms. Grecia
Castro, Office of Air Quality Planning
and Standards, U.S. Environmental
Protection Agency, by phone at (919)
541–1351 or by email at
castro.grecia@epa.gov. To request a
public hearing or information pertaining
to a public hearing on this document,
contact Ms. Pamela Long, Office of Air
Quality Planning and Standards, U.S.
Environmental Protection Agency, by
phone at (919) 541–0641 or by email at
long.pam@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. How is this Federal Register notice
organized?
The information presented in this
document is organized as follows:
I. General Information
A. How is this Federal Register notice
organized?
B. Does this action apply to me?
C. What should I consider as I prepare my
comments for the EPA?
D. How can I find information about a
possible public hearing?
E. Where can I obtain a copy of this
document and other related information?
II. Overview of Action
III. Background
IV. Proposed Revisions
A. What are the e-notice requirements?
B. What are the e-access requirements?
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C. Requirements for Agencies
Implementing the Federal Permit
Program Rules
D. Requirements for Agencies
Implementing Approved Programs
Pursuant to the EPA’s Permitting Rules
for States
E. Soliciting Comment on Allowing
Temporary Use of Alternative Noticing
Methods
F. Clarifying E-Notice and E-Access
Applicability for Minor NSR Permits
G. Notice Requirements for PSD Permit
Rescissions
V. Policy Rationale and Legal Basis
VI. Implementation
A. Agencies Implementing Federal
Preconstruction Permit Program Rules
B. Agencies Implementing State
Preconstruction Permit Program Rules
C. Agencies Implementing Approved
Operating Permit Programs
D. Agencies Delegated to Implement the
Federal Operating Permit Program
VII. Environmental Justice Considerations
VIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
B. Paperwork Reduction Act (PRA)
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act
(UMRA)
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer and
Advancement Act
J. Executive Order 12898: Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations
IX. Statutory Authority
B. Does this action apply to me?
Entities potentially affected by this
proposed rule include air agencies
responsible for the permitting of
stationary and OCS sources of air
pollution or for determining COA
designation for implementation of the
OCS Air Regulations. This includes the
EPA Regions, and both EPA-delegated
air programs and EPA-approved air
programs that are operated by state,
local and tribal governments. Entities
also potentially affected by this
proposed rule include owners and
operators of stationary and OCS sources
that are subject to air pollution
permitting under the CAA, as well as
the general public who would have an
interest in knowing about permitting
actions, public hearings and other
agency actions.
E:\FR\FM\29DEP1.SGM
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[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Proposed Rules]
[Pages 81233-81234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32686]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1271
[Docket No. FDA-2015-D-3719]
Draft Guidances Relating to the Regulation of Human Cells,
Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request
for Comments; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments;
correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting
a notification of a public hearing entitled ``Draft Guidances Relating
to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based
Products; Public Hearing; Request for Comments'' that appeared in the
Federal Register of October 30, 2015 (80 FR 66845). The document
announced a public hearing to obtain input on four recently issued
draft guidances relating to the regulation of human cells, tissues, or
cellular or tissue-based products (HCT/Ps). The document published with
conflicting information about who must register for the public hearing.
This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.
SUPPLEMENTARY INFORMATION: In FR Doc. 2015-27703, appearing on pages
66845 and 66847 in the Federal Register of Friday, October 30, 2015,
the following corrections are made:
1. On page 66845, in the third column under DATES, the third
sentence is revised to read: ``Persons seeking to attend (including FDA
employees) or to present at the public hearing must register by January
8, 2016.''
2. On page 66847, in the first column under section IV. Attendance
and Registration, the third sentence is revised to read: ``Individuals
who wish to attend (including FDA employees) or present at the public
hearing must
[[Page 81234]]
register by sending an email to CBERPublicEvents@fda.hhs.gov on or
before January 8, 2016, and provide complete contact information,
including name, title, affiliation, address, email, and phone number.''
Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32686 Filed 12-28-15; 8:45 am]
BILLING CODE 4164-01-P
