Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry.” The guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components. The guidance, in a question-and-answer format, addresses the most frequently asked questions concerning implementation of the INTERCEPT® Blood System for Platelets and Plasma. The guidance also provides recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of a pathogen reduction device. The guidance announced in this notice finalizes the draft document entitled “Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry,” dated December 2017.

DATES:

The announcement of the guidance is published in the Federal Register on November 4, 2021.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time 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 “Manufacture of Blood Components using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; 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, 240-402-7500.

• 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.govinfo.gov/content/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, 240-402-7500.

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 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:

Tami Belouin, 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 “Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry.” The guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components. The guidance, in a question-and-answer format, addresses the most frequently asked questions on this topic. The guidance also provides recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of a pathogen reduction device under 21 CFR 601.12.

The recommendations in the guidance apply to blood establishments that intend to manufacture pathogen-reduced platelet and plasma products using an FDA approved pathogen reduction device. Currently, the INTERCEPT® Blood System has been approved for the manufacture of certain pathogen-reduced platelet and plasma products. If the product platforms for this FDA approved device change, or FDA approves another pathogen reduction device with a similar intended use in the future, the Agency will consider providing additional recommendations to blood establishments.

In the Federal Register of December 27, 2017 (82 FR 61304), FDA announced the availability of the draft document entitled “Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry.” FDA received a few comments on the draft guidance. The comments addressed various issues, including the indications for use of the INTERCEPT® Blood System for Platelets and Plasma; sampling plans for quality control and validation of the manufacturing process in blood establishments; labeling of pathogen reduced blood components; submissions to FDA for changes to an approved application; and requirements for licensure of pathogen reduced blood components. One comment raised a concern that the guidance addresses a single product. FDA made changes to the guidance to reflect revised labeling for the INTERCEPT® Blood System, and to improve clarity of the recommendations, including those related to quality control and submissions to FDA. Additionally, FDA changed the title of the guidance to clarify that the purpose of the guidance is to provide recommendations for implementing a pathogen reduction device in blood establishments, as opposed to providing recommendations regarding the clinical use of products. However, FDA did not make substantive changes to the guidance in response to the public comments. The guidance announced in this notice finalizes the draft guidance dated December 2017.

This 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 the manufacture of blood components using a pathogen reduction device 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.

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. 3501-3521). 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 parts 606 and 630 have been approved under OMB control number 0910-0116.

III. Electronic Access

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,, https://www.fda.gov/regulatory-information/search-fda-guidance-documents,, or https://www.regulations.gov.