88 FR 121 pgs. 41405-41407 - Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding When Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability
Type: NOTICEVolume: 88Number: 121Pages: 41405 - 41407
Pages: 41405, 41406, 41407Docket number: [Docket No. FDA-2023-D-2034]
FR document: [FR Doc. 2023-13513 Filed 6-23-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2034]
Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding When Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability.
SUMMARY:
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of an immediate in effect guidance entitled "Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical." FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in the biologics regulations regarding blood and blood components. This notice is being issued to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. In addition, the guidance document provides recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP).
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DATES:
The announcement of the guidance is published in the Federal Register on June 26, 2023.
ADDRESSES:
You may submit comments on any guidance 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-2023-D-2034 for "Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability." 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:
Jessica Gillum, 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 an immediate in effect guidance entitled "Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical." FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in subchapter F of chapter I of title 21 of the CFR (21 CFR parts 600-680) regarding blood and blood components. This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. Maintaining platelet availability in the face of logistical challenges ( e.g., in military, prehospital, or austere settings) or other threats to blood availability ( e.g., mass casualty events or public health emergencies) is critical to assure that platelets are available to patients with active bleeding.
In addition, this guidance document provides recommendations to blood establishments for the manufacture and labeling of CSP. The guidance also discusses the need for additional data on the efficacy of CSP, in particular, to address whether their use is supported when conventional platelets are available, and their use is practical.
This guidance is being issued consistent with FDA's good guidance practices regulation (§?10.115 (21 CFR 10.115)). FDA is issuing this guidance for immediate implementation in accordance with §?10.115(g)(3) without initially seeking prior comment because the Agency has determined that prior public participation is not feasible or appropriate (see §?10.115(g)(2)). Specifically, we are not seeking comments before implementing this guidance because of the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical.
[top] The guidance represents the current thinking of FDA on alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 211.100 and 211.160(b) have been approved under OMB control number 0910-0139; the collections of information in 21 CFR 601.12 and Form FDA 356h have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR 606.121 and 21 CFR 606.122 have been approved under OMB control number 0910-0116.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance at 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.
Dated: June 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13513 Filed 6-23-23; 8:45 am]
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