Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products; Availability, 82308-82309 [2011-33572]
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82308
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
Based on FDA’s data on the number of
sponsors that would be covered by the
draft guidance, we estimate that
approximately 180 SOPs related to
histologic evaluation will include the
new procedures, and that sponsors will
need approximately 30 minutes to
document, maintain, and update their
SOPs with the new procedures.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED RECORDKEEPING BURDEN 1
Number of recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
(in hours)
Total hours
30
6
180
0.5
90
..............................
..............................
..............................
..............................
90
SOP New Procedures ............................
Total ................................................
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
IV. 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: December 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33553 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0659]
Guidance for Industry: Current Good
Tissue Practice and Additional
Requirements for Manufacturers of
Human Cells, Tissues, and Cellular and
Tissue-Based Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Current Good
Tissue Practice (CGTP) and Additional
Requirements for Manufacturers of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)’’ dated
December 2011. The guidance
document provides recommendations to
establishments for complying with
CGTP and additional requirements for
manufacturers of HCT/Ps. The guidance
is intended for any HCT/P
establishment that performs a
manufacturing step and is responsible
for complying with CGTP requirements.
The guidance also addresses whether
the establishment registration and HCT/
P listing requirements apply in certain
instances. The guidance announced in
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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19:02 Dec 29, 2011
Jkt 226001
this notice finalizes the draft guidance
of the same title dated January 2009.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–(800) 835–
4709 or (301) 827–1800. 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–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
Jo Churchyard, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, (301) 827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Current Good Tissue Practice
(CGTP) and Additional Requirements
for Manufacturers of Human Cells,
Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)’’ dated December
2011. The guidance provides
recommendations for complying with
the CGTP requirements under part 1271
(21 CFR part 1271), subpart D, and
additional requirements for
manufacturers of HCT/Ps under part
1271, subpart E. The guidance is
intended for any HCT/P establishment
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
that performs a manufacturing step and
is responsible for complying with CGTP
requirements. However, at this time,
part 1271, subpart D (with the
exceptions of §§ 1271.150(c) and
1271.155) and subpart E do not apply to
reproductive HCT/P establishments
regulated solely under section 361 of the
Public Health Service Act (42 U.S.C.
264) (the PHS Act). In consideration of
the input FDA received from
stakeholders, this guidance provides
recommendations for establishments
that manufacture HCT/Ps that meet the
criteria listed in § 1271.10 and are
regulated solely under section 361 of the
PHS Act and the regulations in part
1271. CGTP requirements also apply to
HCT/Ps regulated as drugs, devices,
and/or biological products under
section 351 of the PHS Act (42 U.S.C.
262) and/or the Federal Food, Drug, and
Cosmetic Act (see § 1271.1(b)(2)). The
guidance also addresses whether the
establishment registration and HCT/P
listing requirements under part 1271,
subparts A and B, apply in certain
instances.
In the Federal Register of January 16,
2009 (74 FR 3055), FDA announced the
availability of the draft guidance of the
same title dated January 2009. FDA
received numerous comments on the
draft guidance, and those comments
were considered as the guidance was
finalized. In addition, editorial changes
were made to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated
January 2009.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. 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
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
E:\FR\FM\30DEN1.SGM
30DEN1
Federal Register / Vol. 76, No. 251 / Friday, December 30, 2011 / Notices
II. Paperwork Reduction Act of 1995
The guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 1271 have been approved
under OMB control number 0910–0543,
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
III. 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: December 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–33572 Filed 12–29–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSK4SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
VerDate Mar<15>2010
19:02 Dec 29, 2011
Jkt 226001
Date and Time: The meeting will be
held on February 9, 2012, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, FAX: (301) 847–8533, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–(800)
741–8138; (301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date 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. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: During the morning session,
the committee will discuss
supplemental new drug application
(NDA) 21790/010 for DACOGEN
(decitabine) for injection, application
submitted by Eisai, Inc. The proposed
indication (use) for this product is for
the treatment of acute myelogenous
leukemia (AML) in adults 65 years of
age or older who are not considered
candidates for induction chemotherapy,
which is the standard first phase of
treatment for AML.
During the afternoon session, the
committee will discuss NDA 022481,
with the proposed trade name PIXUVRI
(pixantrone dimaleate) injection,
application submitted by Cell
Therapeutics, Inc. The proposed
indication (use) for this product is as a
single agent treatment for patients with
relapsed or refractory (difficult to treat),
aggressive Non-Hodgkin’s Lymphoma
who received two or more prior lines of
therapy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
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82309
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
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 on or before January 25, 2012.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11 a.m., and 3:30 p.m. to
4 p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before January 17, 2012. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
January 18, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Pages 82308-82309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33572]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0659]
Guidance for Industry: Current Good Tissue Practice and
Additional Requirements for Manufacturers of Human Cells, Tissues, and
Cellular and Tissue-Based Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Current
Good Tissue Practice (CGTP) and Additional Requirements for
Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)'' dated December 2011. The guidance document provides
recommendations to establishments for complying with CGTP and
additional requirements for manufacturers of HCT/Ps. The guidance is
intended for any HCT/P establishment that performs a manufacturing step
and is responsible for complying with CGTP requirements. The guidance
also addresses whether the establishment registration and HCT/P listing
requirements apply in certain instances. The guidance announced in this
notice finalizes the draft guidance of the same title dated January
2009.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-(800) 835-4709 or (301) 827-1800. 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-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, (301) 827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Current Good Tissue Practice (CGTP) and
Additional Requirements for Manufacturers of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)'' dated December 2011. The
guidance provides recommendations for complying with the CGTP
requirements under part 1271 (21 CFR part 1271), subpart D, and
additional requirements for manufacturers of HCT/Ps under part 1271,
subpart E. The guidance is intended for any HCT/P establishment that
performs a manufacturing step and is responsible for complying with
CGTP requirements. However, at this time, part 1271, subpart D (with
the exceptions of Sec. Sec. 1271.150(c) and 1271.155) and subpart E do
not apply to reproductive HCT/P establishments regulated solely under
section 361 of the Public Health Service Act (42 U.S.C. 264) (the PHS
Act). In consideration of the input FDA received from stakeholders,
this guidance provides recommendations for establishments that
manufacture HCT/Ps that meet the criteria listed in Sec. 1271.10 and
are regulated solely under section 361 of the PHS Act and the
regulations in part 1271. CGTP requirements also apply to HCT/Ps
regulated as drugs, devices, and/or biological products under section
351 of the PHS Act (42 U.S.C. 262) and/or the Federal Food, Drug, and
Cosmetic Act (see Sec. 1271.1(b)(2)). The guidance also addresses
whether the establishment registration and HCT/P listing requirements
under part 1271, subparts A and B, apply in certain instances.
In the Federal Register of January 16, 2009 (74 FR 3055), FDA
announced the availability of the draft guidance of the same title
dated January 2009. FDA received numerous comments on the draft
guidance, and those comments were considered as the guidance was
finalized. In addition, editorial changes were made to improve clarity.
The guidance announced in this notice finalizes the draft guidance
dated January 2009.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. 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 used if such approach satisfies the
requirements of the applicable statutes and regulations.
[[Page 82309]]
II. Paperwork Reduction Act of 1995
The guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 1271 have been approved under
OMB control number 0910-0543, and the collections of information in 21
CFR part 820 have been approved under OMB control number 0910-0073.
III. 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.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: December 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33572 Filed 12-29-11; 8:45 am]
BILLING CODE 4160-01-P
