81 FR 12500 - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 46 (March 9, 2016)

Page Range		12500-12501
FR Document		2016-05215

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 The guidance announced in this notice finalizes the draft guidance of the same title dated February 2015.

Federal Register, Volume 81 Issue 46 (Wednesday, March 9, 2016)

[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12500-12501]
From the Federal Register Online [www.thefederalregister.org]
[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

Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12501

Silver Spring, MD 20993–0002. Send adverse reactions related to HCT/Ps to DEPARTMENT OF HEALTH AND
one self-addressed adhesive label to supplement the general instructions HUMAN SERVICES
assist the office in processing your accompanying the MedWatch
requests. The guidance may also be mandatory reporting form, Form FDA Food and Drug Administration
obtained by mail by calling CBER at 1– 3500A. The guidance announced in this [Docket No. FDA–2012–D–0049]
800–835–4709 or 240–402–8010. See notice finalizes the draft guidance of the
the SUPPLEMENTARY INFORMATION section same title dated February 2015. Agency Information Collection
for electronic access to the guidance Activities; Submission for Office of
document. The guidance is being issued
Management and Budget Review;
consistent with FDA’s good guidance
FOR FURTHER INFORMATION CONTACT: Lori Comment Request; Reporting Harmful
practices regulation (21 CFR 10.115). and Potentially Harmful Constituents
J. Churchyard, Center for Biologics The guidance represents the current
Evaluation and Research, Food and in Tobacco Products and Tobacco
thinking of FDA on Investigating and Smoke Under the Federal Food, Drug,
Drug Administration, 10903 New Reporting Adverse Reactions Related to
Hampshire Ave., Bldg. 71, Rm. 7301, and Cosmetic Act
Human Cells, Tissues, and Cellular and
Silver Spring, MD 20993–0002, 240– AGENCY: Food and Drug Administration,
Tissue-Based Products Regulated Solely
402–7911. HHS.
under Section 361 of the Public Health
SUPPLEMENTARY INFORMATION: ACTION: Notice.
Service Act and 21 CFR part 1271;
I. Background Guidance for Industry. It does not SUMMARY: The Food and Drug
FDA is announcing the availability of establish any rights for any person and Administration (FDA) is announcing
a document entitled ‘‘Investigating and is not binding on FDA or the public. that a proposed collection of
Reporting Adverse Reactions Related to You can use an alternative approach if information has been submitted to the
Human Cells, Tissues, and Cellular and it satisfies the requirements of the Office of Management and Budget
Tissue-Based Products (HCT/Ps) applicable statutes and regulations. (OMB) for review and clearance under
Regulated Solely under Section 361 of II. Paperwork Reduction Act of 1995 the Paperwork Reduction Act of 1995.
the Public Health Service Act and 21 DATES: Fax written comments on the
CFR part 1271; Guidance for Industry.’’ The guidance refers to previously collection of information by April 8,
The guidance provides establishments approved collections of information 2016.
that manufacture HCT/Ps, with found in FDA regulations. These ADDRESSES: To ensure that comments on
recommendations for complying with collections of information are subject to the information collection are received,
the requirements for investigating and review by the Office of Management and OMB recommends that written
reporting adverse reactions involving Budget (OMB) under the Paperwork comments be faxed to the Office of
communicable disease in recipients of Reduction Act of 1995 (44 U.S.C. 3501– Information and Regulatory Affairs,
HCT/Ps that are regulated solely under 3520). The collections of information in OMB, Attn: FDA Desk Officer, FAX:
section 361 of the Public Health Service 202–395–7285, or emailed to oira_
21 CFR part 1271 have been approved
Act (PHS Act) and 21 CFR part 1271 submission@omb.eop.gov. All
under OMB control number 0910–0543;
(361 HCT/Ps). comments should be identified with the
In the Federal Register of February and the collections of information in
MedWatch Form FDA 3500A has been OMB control number 0910–0732. Also
20, 2015 (80 FR 9267), FDA announced
approved under OMB control number include the FDA docket number found
the availability of the draft guidance of
0910–0291. in brackets in the heading of this
the same title dated February 2015. FDA
document.
received several comments on the draft III. Electronic Access
guidance and those comments were FOR FURTHER INFORMATION CONTACT: FDA
considered as the guidance was Persons with access to the Internet PRA Staff, Office of Operations, Food
finalized. In addition, editorial changes may obtain the guidance at either and Drug Administration, 8455
were made to improve clarity. http://www.fda.gov/ Colesville Rd., COLE–14526, Silver
The guidance supplements section BiologicsBloodVaccines/ Spring, MD 20993–0002, PRAStaff@
XXII of FDA’s guidance entitled GuidanceCompliance fda.hhs.gov.
‘‘Guidance for Industry: Current Good RegulatoryInformation/Guidances/ SUPPLEMENTARY INFORMATION: In
Tissue Practice (CGTP) and Additional default.htm or http:// compliance with 44 U.S.C. 3507, FDA
Requirements for Manufacturers of www.regulations.gov. has submitted the following proposed
Human Cells, Tissues, and Cellular and collection of information to OMB for
Tissue-Based Products (HCT/Ps)’’ dated Dated: March 2, 2016.
review and clearance.
December 2011 by providing additional Leslie Kux,
recommendations specific to the Associate Commissioner for Policy.
Reporting Harmful and Potentially
responsibilities to investigate Harmful Constituents in Tobacco
[FR Doc. 2016–05215 Filed 3–8–16; 8:45 am]
complaints of adverse reactions Products and Tobacco Smoke Under
BILLING CODE 4164–01–P the Federal Food, Drug, and Cosmetic
concerning 361 HCT/Ps under 21 CFR
1271.160(b)(2), 21 CFR 1271.320 and 21 Act OMB Control Number 0910–0732—
CFR 1271.350(a)(1) and, supersedes the Extension
guidance entitled ‘‘Guidance for On June 22, 2009, the President
Lhorne on DSK5TPTVN1PROD with NOTICES

Industry: MedWatch Form FDA 3500A: signed the Family Smoking Prevention
Mandatory Reporting of Adverse and Tobacco Control Act (Pub. L. 111–
Reactions Related to Human Cells, 31) into law. This law amended the
Tissues, and Cellular and Tissue-Based Food Drug and Cosmetic Act (the FD&C
Products (HCT/Ps)’’ dated November Act) and granted FDA authority to
2005. The guidance provides updated regulate the manufacture, marketing,
information specific to reporting and distribution of tobacco products to

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Document Created: 2016-03-09 00:13:21
Document Modified: 2016-03-09 00:13:21

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		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on Agency guidances at any time.
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.
FR Citation		81 FR 12500

81 FR 12500 - Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 46 (March 9, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration