[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]


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

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Requirements; Draft Guidance for Industry; Availability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.

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

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Eligibility and Source Plasma Quarantine Hold Requirements; Draft 
Guidance for Industry.'' The draft guidance document addresses certain 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 Specifically, the draft 
guidance explains the conditions under which FDA does not intend to 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 FDA expects that the compliance policy described in the draft 
guidance will increase the availability of blood and blood components, 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DATES: Submit either electronic or written comments on the draft 
guidance by July 25, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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proposed collection of information in the draft guidance by July 25, 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Activity/draft guidance section     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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..........................
                                 -------------------------------------------------------------------------------
    Total.......................             400
----------------------------------------------------------------------------------------------------------------
\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


