[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]
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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.
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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The guidance announced in this notice finalizes the draft guidance of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
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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]
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