Document ID: FDA-2016-D-3750-0001
Agency: fda
Document Type: Notice
Title: Guidance: Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates
Posted Date: 2016-11-18T05:00Z

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81779-81780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27768]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3750]

Revised Recommendations for Determining Eligibility of Donors of 
Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have 
Received Human-Derived Clotting Factor Concentrates; 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 ``Revised Recommendations for 
Determining Eligibility of Donors of Human Cells, Tissues, and Cellular 
and Tissue-Based Products Who Have Received Human-Derived Clotting 
Factor Concentrates; Guidance for Industry.'' The guidance document 
provides establishments that make donor eligibility (DE) determinations 
for donors of human cells, tissues, and cellular and tissue-based 
products (HCT/Ps) with information on infectious-disease risks related 
to receipt of FDA licensed human-derived clotting factor concentrates 
(HDCFCs). The guidance explains that FDA no longer considers FDA 
licensed HDCFCs as a risk factor for human immunodeficiency virus 
(HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV). As such, 
receipt of FDA licensed HDCFCs, or sex with a person who has received 
FDA licensed HDCFCs, should not be considered a risk factor when 
determining eligibility of a donor of HCT/Ps. The guidance supplements 
the recommendations regarding HDCFCs that are contained in the guidance 
entitled ``Eligibility Determination for Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for 
Industry'' dated August 2007.

DATES: The Agency is soliciting public comment, but is implementing 
this guidance immediately because the Agency has determined that prior 
public participation is not appropriate. 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'').

[[Page 81780]]

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-2016-D-3750 for ``Revised Recommendations for Determining 
Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products Who Have Received Human-Derived Clotting Factor 
Concentrates; 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, 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: Melissa Segal, 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 ``Revised 
Recommendations for Determining Eligibility of Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products Who Have Received 
Human-Derived Clotting Factor Concentrates; Guidance for Industry.'' 
The guidance document provides establishments that make DE 
determinations for donors of HCT/Ps with information on infectious 
disease risks related to receipt of HDCFCs. The guidance explains that 
FDA no longer considers FDA licensed HDCFCs as a risk factor for HIV, 
HBV, or HCV. As such, receipt of FDA licensed HDCFCs, or sex with a 
person who has received FDA licensed HDCFCs, should not be considered a 
risk factor when determining eligibility of a donor of HCT/Ps. The 
recommendations in the guidance supersede the recommendations contained 
in section IV.E.3. of the guidance entitled ``Eligibility Determination 
for Donors of Human Cells, Tissues, and Cellular and Tissue-Based 
Products (HCT/Ps); Guidance for Industry'' dated August 2007.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). FDA is issuing this guidance for 
immediate implementation in accordance with 21 CFR 10.115(g)(2) without 
initially seeking prior comment because the Agency has determined that 
prior public participation is not appropriate. This guidance recommends 
a less burdensome policy that is consistent with the public health. The 
guidance represents the current thinking of FDA on ``Revised 
Recommendations for Determining Eligibility of Donors of Human Cells, 
Tissues, and Cellular and Tissue-Based Products Who Have Received 
Human-Derived Clotting Factor Concentrates.'' 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

    This 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 1271.47 have been approved under 
OMB control number 0910-0543.

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: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27768 Filed 11-17-16; 8:45 am]
 BILLING CODE 4164-01-P