Document ID: FDA-2018-D-3759-0011
Agency: fda
Document Type: Notice
Title: Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry; Availability
Posted Date: 2019-12-20T05:00Z

[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Notices]
[Pages 70194-70196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27520]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3759]

Considerations for the Development of Dried Plasma Products 
Intended for Transfusion; 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 ``Considerations for the 
Development of Dried Plasma Products Intended for Transfusion; Guidance 
for Industry.'' The guidance document provides recommendations intended 
to assist manufacturers, sponsors, and applicants developing dried 
plasma products intended for transfusion in order to facilitate the 
availability of safe and effective dried plasma products in the United 
States. The guidance document provides considerations for the 
successful development and licensing of dried plasma products and for 
the approval of devices used to manufacture dried plasma. The guidance 
includes recommendations on optimal sources of input plasma; 
manufacturing and product quality, including product characterization; 
packaging and reconstitution; clinical studies; and device submissions. 
The guidance announced in this notice finalizes the draft guidance of 
the same title dated October 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on December 20, 2019.

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

[[Page 70195]]

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-2018-D-3759 for ``Considerations for the Development of Dried 
Plasma Products Intended for Transfusion; 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.gpo.gov/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 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: Jenifer Stach, 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 
``Considerations for the Development of Dried Plasma Products Intended 
for Transfusion; Guidance for Industry.'' This guidance provides 
recommendations intended to assist manufacturers, sponsors, and 
applicants developing dried plasma products intended for transfusion in 
order to facilitate the availability of safe and effective dried plasma 
products in the United States. This guidance provides considerations 
for the successful development and licensing of dried plasma products 
and for the approval of devices used to manufacture dried plasma. The 
guidance includes recommendations on optimal sources of input plasma; 
manufacturing and product quality, including product characterization; 
packaging and reconstitution; clinical studies; and device submissions.
    Plasma is a critical component of early transfusion therapy in the 
management of traumatic hemorrhage. Plasma can replenish various 
coagulation proteins that are consumed during the coagulopathy that may 
accompany traumatic injury. Because plasma products intended for 
transfusion such as fresh frozen plasma, plasma frozen within 24 hours 
after phlebotomy, and plasma frozen within 24 hours after phlebotomy 
held at room temperature up to 24 hours after phlebotomy are stored 
frozen, these products need to be thawed prior to transfusion. This 
limits or prevents the use of plasma in settings where freezers and 
other support equipment are unavailable (e.g., battlefields, remote 
locations, and other austere settings), and may lead to delayed 
administration. Dried plasma (such as freeze-dried or spray-dried 
plasma) offers the potential to address these challenges by providing a 
product that is stable at ambient temperatures, and which can be 
rapidly reconstituted and transfused.
    In the Federal Register of October 30, 2018 (83 FR 54597), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the draft guidance and those comments were 
considered as the guidance was finalized. The guidance announced in 
this notice finalizes the draft guidance dated October 2018.
    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 considerations for the development of dried 
plasma products intended for transfusion. 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. The collections of information in 
21 CFR part 211 have been approved under

[[Page 70196]]

OMB control number 0910-0139; the collections of information in 21 CFR 
part 312 have been approved under OMB control number 0910-0014; 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 610 have been approved under OMB control numbers 0910-0116, 0910-
0139, and 0910-0338; the collections of information in 21 CFR part 630 
have been approved under OMB control number 0910-0116; the collections 
of information in 21 CFR part 640 have been approved under OMB control 
number 0910-0116; the collections of information in 21 CFR part 812 
have been approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

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 or https://www.regulations.gov.

    Dated: December 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27520 Filed 12-19-19; 8:45 am]
 BILLING CODE 4164-01-P