
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12500-12501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05215]


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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; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a 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; Guidance for 
Industry.'' The guidance document provides establishments that 
manufacture 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 
guidance also provides 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 guidance supplements 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 supersedes 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 announced in this notice finalizes 
the draft guidance of the same title dated February 2015.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0349 for ``Investigating and Reporting Adverse Reactions 
Related to Human Cells, Tissues, and Cellular and Tissue-Based Products 
Regulated Solely under Section 361 of the Public Health Service Act and 
21 CFR part 1271; Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the 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,

[[Page 12501]]

Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist the office in processing your requests. The guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

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 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; Guidance for Industry.'' The guidance provides 
establishments that manufacture 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 
(PHS Act) and 21 CFR part 1271 (361 HCT/Ps).
    In the Federal Register of February 20, 2015 (80 FR 9267), FDA 
announced the availability of the draft guidance of the same title 
dated February 2015. FDA received several 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 supplements 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 21 CFR 1271.160(b)(2), 21 CFR 1271.320 and 21 CFR 1271.350(a)(1) 
and, supersedes 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 provides 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 guidance announced in this notice finalizes 
the draft guidance of the same title dated February 2015.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on Investigating and Reporting Adverse 
Reactions Related to Human Cells, Tissues, and Cellular and Tissue-
Based Products Regulated Solely under Section 361 of the Public Health 
Service Act and 21 CFR part 1271; Guidance for Industry. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

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 
MedWatch Form FDA 3500A has been approved under OMB control number 
0910-0291.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05215 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P


