82 FR 61304 - Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 247 (December 27, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing pathogen reduction technology in the manufacture of pathogen-reduced blood components. The guidance also provides answers to frequently asked questions concerning the implementation of the INTERCEPT[supreg] Blood System for Platelets and Plasma. The recommendations apply to licensed blood establishments that intend to manufacture pathogen-reduced blood components using an FDA approved pathogen reduction device.

[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Notices]
[Pages 61304-61306]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-28043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6784]


Implementation of Pathogen Reduction Technology in the 
Manufacture of Blood Components in Blood Establishments: Questions and 
Answers; Draft Guidance for Industry; Availability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 draft document entitled ``Implementation of 
Pathogen Reduction Technology in the Manufacture of Blood Components in 
Blood Establishments: Questions and Answers; Draft Guidance for 
Industry.'' The draft guidance document provides blood establishments 
that collect or process blood and blood components with recommendations 
for implementing pathogen reduction technology in the manufacture of 
pathogen-reduced blood components. The guidance also provides answers 
to frequently asked questions concerning the implementation of the 
INTERCEPT[supreg] Blood System for Platelets and Plasma. The 
recommendations apply to licensed blood establishments that intend to 
manufacture pathogen-reduced blood components using an FDA approved 
pathogen reduction device.

DATES: Submit either electronic or written comments on the draft 
guidance by March 27, 2018 to ensure that the Agency considers your 
comment on this

[[Page 61305]]

draft guidance before it begins work on the final version of the 
guidance.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-D-6784 for ``Implementation of Pathogen Reduction Technology 
in the Manufacture of Blood Components in Blood Establishments: 
Questions and Answer; Draft Guidance for Industry.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 240-402-8010. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, 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 
``Implementation of Pathogen Reduction Technology in the Manufacture of 
Blood Components in Blood Establishments: Questions and Answers; Draft 
Guidance for Industry.'' The draft guidance provides blood 
establishments that collect or process blood and blood components with 
recommendations for implementing pathogen reduction technology in the 
manufacture of pathogen-reduced blood components. The draft guidance 
also provides recommendations to licensed manufacturers on reporting 
the manufacturing changes associated with implementation of pathogen 
reduction technology under 21 CFR 601.12. Currently, the 
INTERCEPT[supreg] Blood System for Platelets and Plasma has been 
approved for the manufacture of certain pathogen-reduced platelet and 
plasma products. The draft guidance provides answers to frequently 
asked questions from blood establishments concerning the implementation 
of the INTERCEPT[supreg] Blood System for Platelets and Plasma. If the 
product platform for this device changes or FDA approves another device 
with a similar intended use in the future, the Agency will consider 
providing additional recommendations to blood establishments.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on implementation 
of pathogen reduction technology in the manufacture of blood components 
in blood establishments. 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. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR part 601 have been approved under OMB control number 0910-0338; 
the collections of information in 21 CFR part 606 have been approved 
under OMB control number 0910-0116; and the collections of information 
in 21 CFR

[[Page 61306]]

630.10 have been approved under OMB control number 0910-0795.

III. Electronic Access

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

    Dated: December 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28043 Filed 12-26-17; 8:45 am]
 BILLING CODE 4164-01-P