80 FR 81233 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 249 (December 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 249 (December 29, 2015)
| Page Range | 81233-81234 | |
| FR Document | 2015-32686 |
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)] [Proposed Rules] [Pages 81233-81234] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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
![Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Proposed Rules 81233
device use may be associated with: talkativeness, and decreased need for Dated: December 18, 2015.
disorientation, confusion, and memory sleep) or a worsening of the psychiatric Leslie Kux,
problems.’’ symptoms they are being treated for. Associate Commissioner for Policy.
(J) Absent performance data (3) The physical risks of ECT may [FR Doc. 2015–32592 Filed 12–28–15; 8:45 am]
demonstrating a beneficial effect of include the following (in order of BILLING CODE 4164–01–P
longer term use, generally considered frequency of occurrence):
treatment in excess of 3 months, the (i) Pain/somatic discomfort (including
following statement, prominently headache, muscle soreness, and nausea). DEPARTMENT OF HEALTH AND
placed: ‘‘Warning: When used as (ii) Skin burns. HUMAN SERVICES
intended this device provides short- (iii) Physical trauma (including
term relief of symptoms. The long-term fractures, contusions, injury from falls, Food and Drug Administration
safety and effectiveness of ECT dental and oral injury).
treatment has not been demonstrated.’’ (iv) Prolonged or delayed onset 21 CFR Part 1271
(ix) Patient labeling must be provided seizures. [Docket No. FDA–2015–D–3719]
and include: (v) Pulmonary complications
(A) Relevant contraindications, (insufficient, or lack of breathing, or Draft Guidances Relating to the
warnings, precautions. inhalation of foreign substance into the Regulation of Human Cells, Tissues, or
(B) A summation of the clinical lungs). Cellular or Tissue-Based Products;
testing, which includes the clinical (vi) Cardiovascular complications Public Hearing; Request for
outcomes associated with the use of the (heart attack, high or low blood Comments; Correction
device, and a summary of adverse pressure, and stroke).
events and complications that occurred (vii) Death. AGENCY: Food and Drug Administration,
with the device. (viii) Devices marketed prior to the HHS.
(C) Information on how the device ACTION: Notification of public hearing;
effective date of this reclassification
operates and the typical course of request for comments; correction.
must have an amendment submitted to
treatment.
(D) The potential benefits. their previously cleared premarket
SUMMARY: The Food and Drug
(E) Alternative treatments. notification (510(k)) that demonstrates
Administration (FDA or Agency) is
(F) The following statement, compliance with these special controls
correcting a notification of a public
prominently placed: ‘‘Warning: ECT within 60 days after the effective date of
hearing entitled ‘‘Draft Guidances
device use may be associated with: this reclassification.
Relating to the Regulation of Human
disorientation, confusion, and memory (2) Classification: Class III (premarket
Cells, Tissues, or Cellular or Tissue-
problems.’’ approval) for the following intended
Based Products; Public Hearing; Request
(G) Absent performance data uses: schizophrenia, bipolar manic
for Comments’’ that appeared in the
demonstrating a beneficial effect of states, schizoaffective disorder,
Federal Register of October 30, 2015 (80
longer term use, generally considered schizophreniform disorder, and
FR 66845). The document announced a
treatment in excess of 3 months, the catatonia.
public hearing to obtain input on four
following statement, prominently (c) Date premarket approval
recently issued draft guidances relating
placed: ‘‘Warning: When used as application (PMA) or notice of
to the regulation of human cells, tissues,
intended this device provides short- completion of product development
or cellular or tissue-based products
term relief of symptoms. The long-term protocol (PDP) is required. A PMA or
(HCT/Ps). The document published
safety and effectiveness of ECT notice of completion of a PDP is
with conflicting information about who
treatment has not been demonstrated.’’ required to be filed with the Food and
must register for the public hearing.
(H) The following statements on Drug Administration on or before [A
This document corrects that error.
known risks of ECT, absent performance DATE WILL BE ADDED 90 DAYS
AFTER DATE OF PUBLICATION OF A FOR FURTHER INFORMATION CONTACT: Lori
data demonstrating that these risks do
FUTURE FINAL ORDER IN THE Jo Churchyard, Center for Biologics
not apply:
(1) ECT treatment may be associated Federal Register], for any Evaluation and Research, Food and
with disorientation, confusion and electroconvulsive therapy device with Drug Administration, 10903 New
memory loss, including short-term an intended use described in paragraph Hampshire Ave., Bldg. 71, Rm. 7301,
(anterograde) and long-term (b)(2) of this section, that was in Silver Spring, MD 20993, 240–402–
(autobiographical) memory loss commercial distribution before May 28, 7911.
following treatment. These side effects 1976, or that has, on or before [A DATE SUPPLEMENTARY INFORMATION: In FR Doc.
tend to go away within a few days to a WILL BE ADDED 90 DAYS AFTER 2015–27703, appearing on pages 66845
few months after the last treatment with DATE OF PUBLICATION OF A and 66847 in the Federal Register of
ECT. However, some patients have FUTURE FINAL ORDER IN THE Friday, October 30, 2015, the following
reported a permanent loss of memories Federal Register], been found to be corrections are made:
of personal life events (i.e., substantially equivalent to any 1. On page 66845, in the third column
autobiographical memory). electroconvulsive therapy device with under DATES, the third sentence is
Improvements in the way ECT is an intended use described in paragraph revised to read: ‘‘Persons seeking to
applied to patients currently, with (b)(2) of this section, that was in attend (including FDA employees) or to
jstallworth on DSK7TPTVN1PROD with PROPOSALS
controlled electric currents and commercial distribution before May 28, present at the public hearing must
electrode placement, can minimize but 1976. Any other electroconvulsive register by January 8, 2016.’’
not completely eliminate, these risks. therapy device with an intended use 2. On page 66847, in the first column
(2) Patients treated with ECT may also described in paragraph (b)(2) of this under section IV. Attendance and
experience manic symptoms (including section shall have an approved PMA or Registration, the third sentence is
euphoria and/or irritability, impulsivity, declared completed PDP in effect before revised to read: ‘‘Individuals who wish
racing thoughts, distractibility, being placed in commercial to attend (including FDA employees) or
grandiosity, increased activity, distribution. present at the public hearing must
VerDate Sep<11>2014 15:26 Dec 28, 2015 Jkt 238001 PO 00000 Frm 00035 Fmt 4702 Sfmt 4702 E:\FR\FM\29DEP1.SGM 29DEP1](https://thefederalregister.org/doc/80_FR_81482/page/1.svg)
![81234 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Proposed Rules
register by sending an email to Once submitted, comments cannot be C. Requirements for Agencies
CBERPublicEvents@fda.hhs.gov on or edited or removed from Regulations.gov. Implementing the Federal Permit
before January 8, 2016, and provide The EPA may publish any comment Program Rules
D. Requirements for Agencies
complete contact information, including received to its public docket. Do not Implementing Approved Programs
name, title, affiliation, address, email, submit electronically any information Pursuant to the EPA’s Permitting Rules
and phone number.’’ you consider to be Confidential for States
Dated: December 21, 2015. Business Information (CBI) or other E. Soliciting Comment on Allowing
Leslie Kux,
information whose disclosure is Temporary Use of Alternative Noticing
restricted by statute. Multimedia Methods
Associate Commissioner for Policy. F. Clarifying E-Notice and E-Access
submissions (audio, video, etc.) must be
[FR Doc. 2015–32686 Filed 12–28–15; 8:45 am] Applicability for Minor NSR Permits
accompanied by a written comment.
BILLING CODE 4164–01–P G. Notice Requirements for PSD Permit
The written comment is considered the Rescissions
official comment and should include V. Policy Rationale and Legal Basis
discussion of all points you wish to VI. Implementation
ENVIRONMENTAL PROTECTION make. The EPA will generally not A. Agencies Implementing Federal
AGENCY consider comments or comment Preconstruction Permit Program Rules
contents located outside of the primary B. Agencies Implementing State
40 CFR Parts 51, 52, 55, 70, 71 and 124 submission (i.e., on the Web, Cloud, or Preconstruction Permit Program Rules
C. Agencies Implementing Approved
[EPA–HQ–OAR–2015–0090, FRL–9937–21– other file sharing system). For Operating Permit Programs
OAR] additional submission methods, the full D. Agencies Delegated to Implement the
EPA public comment policy, Federal Operating Permit Program
RIN 2060–AS59
information about CBI or multimedia VII. Environmental Justice Considerations
Revisions to the Public Notice submissions, and general guidance on VIII. Statutory and Executive Order Reviews
making effective comments, please visit A. Executive Order 12866: Regulatory
Provisions in Clean Air Act Permitting Planning and Review and Executive
Programs http://www2.epa.gov/dockets/
Order 13563: Improving Regulation and
commenting-epa-dockets. Regulatory Review
AGENCY: Environmental Protection FOR FURTHER INFORMATION CONTACT: For B. Paperwork Reduction Act (PRA)
Agency (EPA). general information on this proposed C. Regulatory Flexibility Act (RFA)
ACTION: Proposed rule. rule for NSR and OCS programs, please D. Unfunded Mandates Reform Act
contact Mr. Dave Svendsgaard, Office of (UMRA)
SUMMARY: The U.S. Environmental Air Quality Planning and Standards, E. Executive Order 13132: Federalism
Protection Agency (EPA) proposes to U.S. Environmental Protection Agency, F. Executive Order 13175: Consultation
revise the public notice rule provisions and Coordination With Indian Tribal
by phone at (919) 541–2380 or by email Governments
for the New Source Review (NSR), title at svendsgaard.dave@epa.gov; for title V
V and Outer Continental Shelf (OCS) G. Executive Order 13045: Protection of
programs please contact Ms. Grecia Children From Environmental Health
permit programs of the Clean Air Act Castro, Office of Air Quality Planning and Safety Risks
(CAA) and the corresponding onshore and Standards, U.S. Environmental H. Executive Order 13211: Actions
area (COA) determinations for Protection Agency, by phone at (919) Concerning Regulations That
implementation of the OCS air quality 541–1351 or by email at Significantly Affect Energy Supply,
regulations. This action would remove castro.grecia@epa.gov. To request a Distribution, or Use
the mandatory requirement to provide I. National Technology Transfer and
public hearing or information pertaining Advancement Act
public notice of a draft air permit, as to a public hearing on this document,
well as certain other program actions, J. Executive Order 12898: Federal Actions
contact Ms. Pamela Long, Office of Air to Address Environmental Justice in
through publication in a newspaper and Quality Planning and Standards, U.S. Minority Populations and Low-Income
would instead allow for electronic Environmental Protection Agency, by Populations
noticing (e-notice) of these actions. The phone at (919) 541–0641 or by email at IX. Statutory Authority
proposed rule revisions would apply to long.pam@epa.gov.
major source air permits issued by the SUPPLEMENTARY INFORMATION: B. Does this action apply to me?
EPA, by EPA-delegated air agencies, and Entities potentially affected by this
by air agencies with EPA-approved I. General Information
proposed rule include air agencies
programs (with the exception of permits A. How is this Federal Register notice responsible for the permitting of
that are issued pursuant to the Tribal organized? stationary and OCS sources of air
NSR Rule, which already allows for e- pollution or for determining COA
notice methods). The information presented in this
document is organized as follows: designation for implementation of the
DATES: Comments. Comments must be OCS Air Regulations. This includes the
received on or before February 29, 2016. I. General Information EPA Regions, and both EPA-delegated
Public hearing. If anyone contacts us A. How is this Federal Register notice
organized? air programs and EPA-approved air
requesting a public hearing on or before B. Does this action apply to me? programs that are operated by state,
January 13, 2016, we will hold a C. What should I consider as I prepare my local and tribal governments. Entities
hearing. Additional information about comments for the EPA? also potentially affected by this
jstallworth on DSK7TPTVN1PROD with PROPOSALS
the hearing, if requested, will be D. How can I find information about a proposed rule include owners and
published in a subsequent Federal possible public hearing? operators of stationary and OCS sources
Register document. E. Where can I obtain a copy of this that are subject to air pollution
document and other related information?
ADDRESSES: Submit your comments,
II. Overview of Action
permitting under the CAA, as well as
identified by Docket ID No. EPA–HQ– III. Background the general public who would have an
OAR–2015–0090, at http:// IV. Proposed Revisions interest in knowing about permitting
www.regulations.gov. Follow the online A. What are the e-notice requirements? actions, public hearings and other
instructions for submitting comments. B. What are the e-access requirements? agency actions.
VerDate Sep<11>2014 15:26 Dec 28, 2015 Jkt 238001 PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 E:\FR\FM\29DEP1.SGM 29DEP1](https://thefederalregister.org/doc/80_FR_81482/page/2.svg)
Document Created: 2015-12-29 10:15:54
Document Modified: 2015-12-29 10:15:54
| 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 | Proposed Rules | |
| Action | Notification of public hearing; request for comments; correction. | |
| 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. | |
| FR Citation | 80 FR 81233 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR