Document ID: FDA-2015-D-0349-0001
Agency: fda
Document Type: Notice
Title: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
Posted Date: 2015-02-20T05:00Z

[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)]
[Notices]
[Pages 9267-9268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03490]

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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Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance 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.

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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 The draft guidance document is intended to provide manufacturers 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 The draft guidance, when finalized, is 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draft guidance before it begins work on the final version of the 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]
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