[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54597-54598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23637]
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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Intended for Transfusion; Draft Guidance for Industry; Availability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 ``Considerations for the
Development of Dried Plasma Products Intended for Transfusion; Draft
Guidance for Industry.'' This guidance is 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 The draft guidance document provides considerations for the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.
DATES: Submit either electronic or written comments on the draft
guidance by January 28, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
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-2018-D-3759 for ``Considerations for the Development of Dried
Plasma Intended for Transfusion; 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.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 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
``Considerations for the Development of Dried Plasma Products Intended
for Transfusion; Draft Guidance for Industry.'' 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 can accompany traumatic injury.
Because plasma products intended for transfusion such as fresh frozen
plasma (FFP), plasma frozen within 24 hours after phlebotomy (PF24),
and plasma frozen within 24 hours after phlebotomy held at room
temperature up to 24 hours after phlebotomy (PF24, RT24) are stored
frozen, these products need to be thawed prior to transfusion. This
limits
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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 can be rapidly reconstituted and
transfused.
Recent clinical studies have demonstrated promising efficacy and
safety of dried plasma, particularly in military applications, and
dried plasma products are available for limited use in Germany, South
Africa, and France. This guidance is 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 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 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. 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 subject to review by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 211 have been approved
under 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 draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23637 Filed 10-29-18; 8:45 am]
BILLING CODE 4164-01-P