[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Proposed Rules]
[Pages 31440-31442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11120]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 630 and 640
[Docket No. FDA-2022-D-0588]
Compliance Policy Regarding Blood and Blood Component Donation
Suitability, Donor Eligibility and Source Plasma Quarantine Hold
Requirements; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability, draft compliance policy.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft document entitled ``Compliance
Policy Regarding Blood and Blood Component Donation Suitability, Donor
Eligibility and Source Plasma Quarantine Hold Requirements; Draft
Guidance for Industry.'' The draft guidance document addresses certain
requirements that apply to blood establishments that collect blood and
blood components, including Source Plasma. Specifically, the draft
guidance explains the conditions under which FDA does not intend to
take regulatory action for a blood establishment's failure to comply
with certain requirements in the biologics regulations regarding
donation suitability, donor eligibility, and quarantine hold for Source
Plasma. FDA expects that the compliance policy described in the draft
guidance will increase the availability of blood and blood components,
including Source Plasma, while maintaining the health of blood donors
and the safety of blood and blood components.
DATES: Submit either electronic or written comments on the draft
guidance by July 25, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by July 25,
2022.
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-2022-D-0588 for ``Compliance Policy Regarding Blood and Blood
Component Donation Suitability, Donor Eligibility and Source Plasma
Quarantine Hold Requirements; 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, 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 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:
With regard to the draft guidance: Phillip Kurs, Center for
Biologics
[[Page 31441]]
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733,[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Compliance Policy Regarding Blood and Blood Component Donation
Suitability, Donor Eligibility and Source Plasma Quarantine Hold
Requirements.'' The draft guidance document addresses certain
requirements that apply to blood establishments that collect blood and
blood components, including Source Plasma. Specifically, the draft
guidance explains the conditions under which FDA does not intend to
take regulatory action for a blood establishment's failure to comply
with certain requirements in title 21 of the Code of Federal
Regulations Sec. 630.30 (21 CFR 630.30) regarding donation
suitability; 21 CFR 630.10(c)(2) regarding donor eligibility; and 21
CFR 640.69(f) regarding quarantine hold for Source Plasma.
To address the urgent and immediate need for blood and blood
components during the Coronavirus Disease 2019 (COVID-19) public health
emergency, FDA issued certain exceptions and alternatives to the
requirements regarding blood and blood components under 21 CFR
640.120(b) through the guidance entitled, ``Alternative Procedures for
Blood and Blood Components During the COVID-19 Public Health Emergency;
Guidance for Industry'' dated April 2020 (April 2020 guidance).
Since publication of the April 2020 guidance, FDA has received
numerous comments from the blood industry requesting that FDA continue
to permit the exceptions and alternatives beyond the public health
emergency related to COVID-19 because the changes have increased
availability of blood and blood components while maintaining the health
of blood donors and safety of blood and blood components. Further,
blood establishments have requested that FDA provide our
recommendations before the end of the public health emergency to reduce
the operational burdens associated with changes in standard operating
procedures and blood establishment computer systems. FDA is issuing
this guidance after considering the public comments, available data on
donor health and the safety and availability of blood and blood
components since publication of the April 2020 guidance, and the
applicable regulations.
FDA expects that the compliance policy described in this draft
guidance will increase the availability of blood and blood components,
including Source Plasma, while maintaining the health of blood donors
and the safety of blood and blood components.
While the April 2020 guidance is intended to remain in effect only
for the duration of the public health emergency (PHE) related to COVID-
19 declared by the Department of Health and Human Services (HHS),
including any renewals made by the HHS Secretary in accordance with
section 319(a)(2) of the Public Health Service Act (PHS Act), the draft
guidance ``Compliance Policy Regarding Blood and Blood Component
Donation Suitability, Donor Eligibility and Source Plasma Quarantine
Hold Requirements,'' when finalized, will remain in effect even after
the HHS Secretary declares that this PHE no longer exists or the
expiration of the 90-day period beginning on the date the HHS Secretary
issues a renewal of the determination that a PHE exists.
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 FDA's current thinking on compliance with
blood and blood component donation suitability, donor eligibility and
Source Plasma quarantine hold requirements. 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
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Compliance Policy Regarding Blood and Blood Component Donation
Suitability, Donor Eligibility and Source Plasma Quarantine Hold
Requirements
OMB Control Number 0910-0116--Revision
As noted, blood establishments that collect blood and blood
components, including Source Plasma, must comply with requirements in
Sec. 630.30 regarding donation suitability. The draft guidance
explains the conditions under which FDA does not intend to take
regulatory action for a blood establishment's failure to comply with
this requirement and describes proposed procedures in section III.A.
under the heading ``Record Maintenance, Investigation and Annual
Reporting'' for such an establishment's filing of annual reports on the
release of unsuitable donations to FDA. FDA will use the reports to
monitor error rates associated with the collection of unsuitable
donations and work with establishments to implement corrective actions,
if necessary. The information is needed to support FDA's efforts to
protect the health of blood donors and the safety of blood and blood
components. We are requesting approval to revise the scope of the
information collections included in OMB control number 0910-0116 to
include the information collection associated with the draft guidance.
Description of Respondents: Licensed and registered-only
establishments that collect blood and blood components for transfusion
and further manufacturing, and elect to release unsuitable donations
pursuant to the compliance policy described in the guidance.
[[Page 31442]]
Burden Estimate: FDA estimates the burden of this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity/draft guidance section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Annual report--Licensed blood 50 1 50 4 200
collection establishments/
Section III.A..................
Annual report--Registered-only 50 1 50 4 200
blood establishments/Section
III.A..........................
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Total....................... 400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimate of the proposed reporting provisions in the
guidance on our experience with similar information collections and a
review of similar Agency data.
This draft guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338 and the
collections of information in 21 CFR parts 606 and 630 have been
approved under OMB control number 0910-0116.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either 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: May 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11120 Filed 5-23-22; 8:45 am]
BILLING CODE 4164-01-P