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  Contains Nonbinding Recommendations 
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
  i  Contains Nonbinding Recommendations 
 
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 FDAs 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, FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, these guidances describe the FDAs 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 FDAs guidances means that something is 
suggested or recommended, but not required. 
 
1 See section III of this guidance for certain exceptions. 
  1  Contains Nonbinding Recommendations 
 
 
 
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 donors overall good health and that the donor is free from transfusion-
transmitted infection (21 CFR 630.10(a)).  A donors eligibility to donate blood and blood 
components, including Source Plasma, is determined in part by a physical assessment and the 
donors 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 donors response to capture questions. 
(Capture questions ask a general question about a donors 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 donors 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.  
  2  Contains Nonbinding Recommendations 
 
 
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 FDAs 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.  
 
  3  Contains Nonbinding Recommendations 
 
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. 
  4  Contains Nonbinding Recommendations 
 
 
 
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.  
  5  Contains Nonbinding Recommendations 
 
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.   
  6