[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Pages 14682-14684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2001-D-0007 (formerly Docket No. 2001D-0221)]
Biological Product Deviation Reporting for Blood and Plasma
Establishments; 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, Agency, or we) is
announcing the availability of a revised final guidance entitled
``Biological Product Deviation Reporting for Blood and Plasma
Establishments; Guidance for Industry.'' The final guidance document
provides blood and plasma establishments with revised recommendations
related to biological product deviation (BPD) reporting. The guidance
is intended to assist blood and plasma establishments in determining
when a report is required, who submits the report, what information to
submit in the report, the timeframe for reporting, and how to submit
the report. The revised guidance explains that we do not consider post
donation information (PDI) events to require BPD reports. The revised
guidance also contains other technical updates and editorial revisions
to improve clarity and provide a more streamlined document. For the
purposes of this guidance, ``blood and plasma establishment'' includes
licensed manufacturers of blood and blood components, including Source
Plasma, unlicensed registered blood establishments, and transfusion
services. The guidance announced in this notice supersedes the document
entitled ``Guidance for Industry: Biological Product Deviation
Reporting for Blood and Plasma Establishments,'' dated October 2006.
DATES: The Agency is soliciting public comment, but is implementing
this guidance immediately, because the Agency has determined that prior
public participation is not feasible or appropriate. Submit either
electronic or written comments on Agency guidances at any time. The
announcement of the guidance is published in the Federal Register on
March 13, 2020.
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
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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-2001-D-0007 for ``Biological Product Deviation Reporting for Blood
and Plasma Establishments; 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.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.
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 final guidance to
the Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, 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 that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to 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 revised document entitled
``Biological Product Deviation Reporting for Blood and Plasma
Establishments; Guidance for Industry.'' The final guidance document
provides blood and plasma establishments with revised recommendations
related to BPD reporting. The guidance is intended to assist blood and
plasma establishments in determining when a report is required, who
submits the report, what information to submit in the report, the
timeframe for reporting, and how to submit the report. The revised
guidance explains that we do not consider PDI events to require BPD
reports. The revised guidance also contains other technical updates and
editorial revisions to improve clarity and provide a more streamlined
document. For the purposes of this guidance, ``blood and plasma
establishment'' includes licensed manufacturers of blood and blood
components, including Source Plasma, unlicensed registered blood
establishments, and transfusion services. The guidance announced in
this notice supersedes the document entitled ``Guidance for Industry:
Biological Product Deviation Reporting for Blood and Plasma
Establishments,'' dated October 2006.
FDA is also announcing the withdrawal of two obsolete memoranda to
blood establishments entitled ``Responsibilities of Blood
Establishments Related to Errors and Accidents in the Manufacture of
Blood and Blood Components,'' issued March 20, 1991, and ``Guidance
Regarding Post Donation Information Reports,'' issued December 10,
1993.
The revised guidance explains that we do not consider PDI events to
require BPD reports under Sec. 606.171 (21 CFR 606.171) because these
events are no longer unexpected or unforeseeable based on 18 years of
data, which show that more than 18,000 reports of PDI events have been
submitted to FDA each fiscal year (FY) for the past 18 years.
Every year, the Center for Biologics Evaluation and Research (CBER)
receives thousands of BPD reports of events associated with
manufacturing, to include testing, processing, packing, labeling, or
storage, or with the holding or distribution of both licensed and
unlicensed blood or blood components, including Source Plasma. Such an
event is reportable under Sec. 606.171 if certain criteria are met,
including that the event either: (1) Represents a deviation from
current good manufacturing practice (CGMP), applicable regulations,
applicable standards, or established specification that may affect the
safety, purity, or potency of the product; or (2) represents an
unexpected or unforeseeable event that may affect the safety, purity,
or potency of the product. The Agency's BPD reporting program is one of
the post-market surveillance tools that CBER uses to monitor blood
manufacturing and to detect potential blood safety issues.
One type of BPD report received by FDA from blood establishments
involves PDI events. PDI includes information that a donor, or other
reliable source, provides to a blood establishment following a donation
(e.g., at a subsequent donation) that would have resulted in donor
deferral had it been known by the establishment at the time of
donation. In these situations, the relevant donor screening questions
were asked at the original donation, but the donor did not provide the
information at that time.
In the Federal Register of November 7, 2000 (65 FR 66635), FDA
issued a final rule to amend the regulations for biological product
deviation reporting. In the October 2006 guidance, ``Biological Product
Deviation Reporting for Blood and Plasma Establishments,'' FDA
explained that it considered PDI events to be ``unexpected or
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unforeseeable'' events for purposes of BPD reporting (see Sec.
606.171(b)(1)(ii)). Accordingly, establishments have been submitting
BPD reports regarding PDI that may affect the safety, purity, or
potency of a distributed product. PDI events continue to be reported,
and the numbers have increased over time. Reports of PDI events have
consistently been the highest number of reports received from blood
establishments, representing a significant burden to industry and FDA.
For example, from FYs 2000 through 2017, FDA has received approximately
18,000 to 40,000 PDI reports each year. The total number of PDI reports
submitted by blood establishments in FY 2017 was 37,265 of 51,434 total
BPD reports, representing approximately 72 percent of all BPD reports
submitted by blood establishments. In reviewing the data for the past
18 years, based on the extraordinarily high number of PDI reports, FDA
has concluded that PDI events are no longer ``unexpected or
unforeseeable,'' and will likely continue to occur. Because PDI events
are no longer ``unexpected or unforeseeable,'' and also do not
represent deviations from CGMP, applicable regulations, applicable
standards, or established specifications, such events are not
reportable under Sec. 606.171.
FDA is issuing this guidance for immediate implementation in
accordance with Sec. 10.115(g)(3) (21 CFR 10.115(g)(3)) without
initially seeking prior comment because the Agency has determined that
prior public participation is not feasible or appropriate (see Sec.
10.115(g)(2)). Specifically, we made this determination because this
guidance presents a less burdensome policy for reporting BPDs that is
consistent with public health. It eliminates the reporting of PDI
events as BPD reports because these reports are no longer unexpected or
unforeseeable based on PDI data for the past 18 years, without
compromising public health protections.
This guidance is expected to significantly reduce the BPD reporting
burden on industry and the burden on FDA to review these reports. Based
on the above FY 2017 PDI data, FDA expects that the elimination of PDI
reports will result in a 72 percent reduction in total BPD reports
received (elimination of 37,265 of 51,434 total reports in FY 2017).
FDA anticipates that this will substantially and proportionally reduce
the blood industry's estimated annual reporting burden under Sec.
606.171, which FDA recently estimated to be 92,384 total annual hours
(84 FR 70979 at 70981; December 26, 2019). The revised recommendations
are also consistent with public health.
Given the substantial number of PDI reports FDA has received, the
Agency is aware that these events occur, and the submission of
additional PDI reports to FDA is unlikely to facilitate the
identification of manufacturing or safety issues. PDI events are not
associated with deviations from CGMP or other requirements, and blood
establishments generally have no control over information provided by
donors or third parties subsequent to a donation. Eliminating PDI
reports will enable blood establishments and FDA to prioritize
resources on BPD reports that are more likely to inform corrective
actions to protect the public health. Additionally, blood
establishments are required to comply with applicable regulations
regarding, among other things, establishing, maintaining, and following
standard operating procedures (SOPs) (see Sec. 606.100(b) (21 CFR
606.100(b)) and maintaining records (see Sec. 606.160 (21 CFR
606.160)). FDA will continue to assess SOPs and records associated with
PDI events during routine inspections of blood establishments. Thus,
this revised guidance presents a less burdensome policy for reporting
PDI events that is consistent with public health.
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). FDA is issuing this guidance for
immediate implementation in accordance with Sec. 10.115(g)(3) without
initially seeking prior comment because the Agency has determined that
prior public participation is not feasible or appropriate. The guidance
represents the current thinking of FDA on biological product deviation
reporting for blood and plasma 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 FDA collections of
information. 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 under
Sec. Sec. 600.14 and 606.171 were approved under OMB control number
0910-0458; the collections of information under Sec. Sec. 606.100 and
606.160 were approved under OMB control number 0910-0116; the
collections of information under 21 CFR 211.192 and 211.198 were
approved under OMB control number 0910-0139; and the collections of
information under 21 CFR 601.12 were approved under OMB control number
0910-0338.
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: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05103 Filed 3-12-20; 8:45 am]
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