[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)]
[Notices]
[Pages 9267-9268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03490]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0349]
Investigating and Reporting Adverse Reactions Related to Human
Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance
for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Investigating and Reporting
Adverse Reactions Related to Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of
the Public Health Service Act and 21 CFR part 1271'' dated February
2015. The draft guidance document is intended to provide manufacturers
of human cells, tissues, and cellular and tissue-based products (HCT/
Ps) for which no premarket submissions are required because they are
not also regulated as drugs, devices, and/or biological products, with
recommendations for complying with the requirements for investigating
and reporting adverse reactions involving communicable disease in
recipients of these HCT/Ps. The draft guidance, when finalized, is
intended to supplement section XXII of FDA's guidance 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 and
supersede the guidance entitled ``Guidance for Industry: MedWatch Form
FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated
November 2005.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 21, 2015.
[[Page 9268]]
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
the office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
Submit electronic comments on the draft guidance to http://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 J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Investigating and Reporting Adverse Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated
Solely Under Section 361 of the Public Health Service Act and 21 CFR
part 1271'' dated February 2015. The draft guidance document is
intended provide manufacturers of HCT/Ps, with recommendations for
complying with the requirements for investigating and reporting adverse
reactions involving communicable disease in recipients of HCT/Ps that
are regulated solely under section 361 of the Public Health Service Act
(42 U.S.C. 264) and 21 CFR part 1271 (361 HCT/Ps).
The draft guidance, when finalized, is intended to supplement
section XXII of FDA's guidance 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 by providing additional
recommendations specific to the responsibilities to investigate
complaints of adverse reactions concerning 361 HCT/Ps under Sec. Sec.
1271.160(b)(2), 1271.320 and 1271.350(a)(1).
The draft guidance, when finalized, is intended to supersede the
guidance entitled ``Guidance for Industry: MedWatch Form FDA 3500A:
Mandatory Reporting of Adverse Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated
November 2005. The guidance will provide updated information specific
to reporting adverse reactions related to HCT/Ps to supplement the
general instructions accompanying the MedWatch mandatory reporting
form, Form FDA 3500A.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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 requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The draft 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 part 1271 have been approved under OMB
control number 0910-0543 and OMB control number 0910-0291.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit either electronic comments regarding this document to http://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 http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: February 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03490 Filed 2-19-15; 8:45 am]
BILLING CODE 4164-01-P