Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma: Guidance for Industry

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Implementation of Acceptable Full-
Length and Abbreviated Donor
History Questionnaires and
Accompanying Materials for Use in
Screening Donors of Source Plasma
Guidance for Industry
This guidance is for immediate implementation.
FDA is issuing this guidance for immediate implementation in accordance with
21 CFR 10.115(g)(4)(i). Submit one set of either electronic or written comments on this
guidance at any time. Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with
docket number FDA-2016-D-1533.
Additional copies of this guidance are available from the Office of Communication, Outreach
and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring,
MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@fda.hhs.gov, or
from the Internet at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-
regulatory-information-biologics/biologics-guidances.
For questions on the content of this guidance, contact OCOD at the phone numbers or email
address listed above.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
June 2023

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Table of Contents
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	RECOGNITION OF SPDHQ DOCUMENTS ............................................................... 2
IV. 	REPORTING IMPLEMENTATION OF ACCEPTABLE SPDHQ DOCUMENTS 3
V. 	FOR MORE INFORMATION ........................................................................................ 5
VI. 	REFERENCES.................................................................................................................. 6

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Implementation of Acceptable Full-Length and Abbreviated Donor
History Questionnaires and Accompanying Materials for Use in
Screening Donors of Source Plasma
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. 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. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.
I. 	INTRODUCTION
This guidance recognizes, as acceptable, the standardized full-length and abbreviated donor
history questionnaires and accompanying materials, version 3.0 dated June 2023, prepared by the
Plasma Protein Therapeutics Association (PPTA).1 This guidance also advises Source Plasma
manufacturers on how to report implementation of the acceptable PPTA Source Plasma donor
history questionnaires and accompanying materials (SPDHQ documents) under Title 21 of the
Code of Federal Regulations 601.12 (21 CFR 601.12).
The SPDHQ documents provide establishments that collect Source Plasma with a specific
process for administering questions to donors to determine their eligibility to donate. Acceptable
SPDHQ documents are those documents that FDA has determined provide Source Plasma
collection establishments with one means of obtaining donor history information to determine if
a donor is eligible, consistent with FDA requirements and recommendations. The SPDHQ
documents have been updated to align with FDA’s current requirements and recommendations
for donor eligibility.
This guidance supersedes the document entitled “Implementation of an Acceptable Full-Length
and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in
Screening Donors of Source Plasma” dated May 2020.
In general, FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, these guidances describe the FDA’s current thinking on a
topic and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in FDA’s guidances means that something is
suggested or recommended, but not required.
1 See section III of this guidance for certain exceptions.

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II. 	BACKGROUND
Section 630.10(c) requires the eligibility of all donors to be determined on the day of donation
and before collection, with certain exceptions (21 CFR 630.10(c)(1)-(2)). Such determination is
intended to ensure a donor’s overall good health and that the donor is free from transfusion-
transmitted infection (21 CFR 630.10(a)). A donor’s eligibility to donate blood and blood
components, including Source Plasma, is determined in part by a physical assessment and the
donor’s answers to questions concerning medical history and risk factors associated with
exposure to, or clinical evidence of a relevant transfusion-transmitted infection and other
conditions that may adversely affect the health of the donor or the safety, purity, or potency of
the blood or blood components or any product manufactured from the blood or blood
components.
The SPDHQ documents include the following materials:
• 	Full-Length PPTA Donor History Questionnaire.
• 	Full-Length PPTA Donor History Questionnaire Directions for Use – includes glossary,
flow charts and references; describes how questions can be administered; and contains
follow-up questions to further evaluate a potential donor’s response to capture questions.
(“Capture” questions ask a general question about a donor’s history or behavior and are
followed up by obtaining additional information about the donor if needed.)
• 	Abbreviated PPTA Donor History Questionnaire.
• 	Abbreviated PPTA Donor History Questionnaire Directions for Use – includes glossary,
flow charts and references; describes which donors may complete the questionnaire and
how the questions can be administered; and contains follow-up questions to further
evaluate a potential donor’s response to capture questions.
• 	Medication List – contains a list of medications that may serve as a basis for donor
deferral.
• 	Risk Poster – educates the donor about risks and conditions that are a basis for donor
deferral.
The full-length and abbreviated donor history questionnaires are designed to be implemented
together. In other words, if you choose to implement the Abbreviated PPTA Donor History
Questionnaire, you should also implement the Full-Length PPTA Donor History Questionnaire
as described in the Directions for Use. Both the full-length and abbreviated donor history
questionnaires are administered by Source Plasma establishment personnel or self-administered
by the donor with follow up by establishment personnel.
III. 	RECOGNITION OF SPDHQ DOCUMENTS
We, FDA, find the SPDHQ documents version 3.0 dated June 2023, acceptable for use in
screening Source Plasma donors. These documents are consistent with FDA requirements and
recommendations for donor eligibility.

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Note, the SPDHQ documents contain questions related to the following donor medical history
factors for which we currently do not have requirements or recommendations, including: cancer;
certain organ, tissue, or bone marrow transplant; bone or skin graft; nervous system disease;
diabetes; history of fainting, seizures or convulsions; relapsing disease; surgery, diagnostic or
dental procedures; or acupuncture. By recognizing the acceptable SPDHQ documents as one
way to satisfy FDA’s regulatory requirements, we are not requiring or recommending that donors
be screened or deferred for these factors. If you choose to implement the acceptable SPDHQ
documents and omit these questions, you would still be in compliance with FDA requirements.
In addition, the acceptable SPDHQ documents include a donor acknowledgement statement.
Note, the use of this statement alone does not meet the requirements for donor acknowledgement
as described in 21 CFR 630.10(g)(2). You must establish procedures in accordance with 21 CFR
606.100 to ensure that the requirements in 21 CFR 630.10(g)(2) have been satisfied.
While we recognize that the acceptable SPDHQ documents provide an effective tool for
screening donors, we do not require that you implement the acceptable SPDHQ documents. You
may use full-length and abbreviated donor history questionnaires and accompanying materials
developed by your establishment that are consistent with current FDA requirements and
recommendations and approved by FDA. These materials may include procedures and wording
that are different from those in the acceptable SPDHQ documents.
IV. 	REPORTING IMPLEMENTATION OF ACCEPTABLE SPDHQ DOCUMENTS
Licensed establishments must report the implementation of the acceptable SPDHQ documents to
FDA under 21 CFR 601.12 as follows:
1. 	If the acceptable SPDHQ documents are implemented without modifications and in their
entirety as a complete process for administering questions to Source Plasma donors, the
change is considered to be minor. You must report such changes to FDA in your annual
report under 21 CFR 601.12(d), noting the date the process was implemented.
2. 	If the acceptable SPDHQ documents are implemented in their entirety, but modified by:
(a) adding additional, more restrictive selection criteria that are specific to your
establishment; (b) omitting questions not required or recommended by FDA for
determining donor eligibility including those related to: cancer; organ, tissue, or bone
marrow transplant, except for xenotransplantation; bone or skin graft; nervous system
disease; diabetes; history of fainting, seizures or convulsions; relapsing disease; surgery,
diagnostic or dental procedures; or acupuncture; or (c) omitting the donor
acknowledgement statement and using your own materials to satisfy the requirements in
21 CFR 630.10(g)(2), the changes are considered to be minor. You must report such
changes to FDA in your annual report under 21 CFR 601.12(d), noting the date the
process was implemented and describing the additional criteria or the questions or
statements that were omitted from your questionnaire.

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3. 	If the acceptable SPDHQ documents are implemented in their entirety but modified by
displaying the flow charts in another format that is compatible with your current process,
the changes are considered minor, provided there is no change to the content in the
SPDHQ flow charts, other than changes incorporating donor deferral criteria that are
stricter than the FDA required/recommended donor deferral criteria. You must report
such changes to FDA in your annual report under 21 CFR 601.12(d), noting the date the
process was implemented and describing how you modified the acceptable SPDHQ
documents.
4. 	If the acceptable SPDHQ documents are implemented in their entirety but are modified
by reformatting any of the acceptable SPDHQ documents (other than the flow charts) to
be consistent with your current process, the changes are considered to be minor, provided
you do not change the wording and the order of content in the acceptable SPDHQ
documents. You must report such changes to FDA in your annual report under 21 CFR
601.12(d), noting the date the process was implemented and describing how you
modified the acceptable SPDHQ documents.
5. 	If the acceptable SPDHQ documents are implemented using a new computer-assisted
interactive interview procedure, this is considered a moderate change. You must report
the change as a Changes Being Effected in 30 Days (CBE30) supplement under 21 CFR
601.12(c). For recommendations on preparing the CBE30 for the computer-assisted
interactive interview procedure, see the guidance entitled, “Guidance for Industry:
Streamlining the Donor Interview Process: Recommendations for Self-Administered
Questionnaires,” dated July 2003 (Ref. 1).
Note, if you are already approved to implement a computer-assisted interactive interview
procedure and you are revising your procedures to incorporate the acceptable SPDHQ
documents as described in sections IV. 1-4 of this guidance, the change is considered to
be minor. You must report this change to FDA in your Annual Report under 21 CFR
601.12(d), noting the date the process was implemented.
6. 	Implementation of the acceptable SPDHQ documents that have been modified other than
as specifically described in sections IV. 2-4 of this guidance is considered a major
change. If you wish to implement the acceptable SPDHQ documents modified in a
manner other than as described in sections IV. 2-4 of this guidance, you must report such
changes as a Prior Approval Supplement (PAS) under 21 CFR 601.12(b). We
recommend that you include the following in the submission:
a. 	FDA Form 356h “Application to Market a New Drug, Biologic or an Antibiotic
Drug for Human Use” which may be obtained at
https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm;
b. 	A cover letter describing the request and the contents of the submission;
c. 	A Standard Operating Procedure (SOP) describing the donor questions and
questionnaire process; and
d. 	The donor history questionnaires and accompanying document(s). Please
highlight the modifications.

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V. 	FOR MORE INFORMATION
If you have questions regarding this guidance, contact OCOD at the phone numbers or email
address provided in this guidance.
If you have questions regarding the SPDHQ documents, contact PPTA by phone at (202) 789-
3100, by fax at (410) 263-2298 or online at https://www.pptaglobal.org/about-ppta#Contact.
The acceptable SPDHQ documents can be accessed on the PPTA website at
https://www.pptaglobal.org/material/ppta-donor-history-questionnaire.

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VI. 	REFERENCES
1. 	Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for
Self-Administered Questionnaires, July 2003. Available at
https://www.fda.gov/media/70688/download.