Implementation of Acceptable Full-
Length and Abbreviated Donor History 
Questionnaires and Accompanying 
Materials for Use in Screening Donors of 
Blood and Blood Components 
 
 
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-1342.   
 
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 e-mail 
address listed above. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
May 2023  Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  RECOGNITION OF DHQ DOCUMENTS ................................................................... 3 
IV.  REPORTING IMPLEMENTATION OF ACCEPTABLE DHQ DOCUMENTS ..... 3 
V.  FOR MORE INFORMATION ........................................................................................ 4 
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 Blood and Blood Components 
 
 
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 4.0 dated May 2023, prepared by the 
AABB Donor History Task Force1.  This guidance also provides recommendations to licensed 
establishments on how to report implementation of the acceptable AABB donor history 
questionnaires and accompanying materials (DHQ documents) under Title 21 of the Code of 
Federal Regulations 601.12 (21 CFR 601.12).  
 
The DHQ documents provide blood establishments that collect blood and blood components 
with a specific process for administering questions to donors of blood and blood components to 
determine their eligibility to donate.  Acceptable DHQ documents are those documents that FDA 
has determined provide blood establishments with one means of obtaining donor history 
information to determine if a donor is eligible, consistent with FDA requirements and 
recommendations.  The DHQ documents have been updated to align with FDAs current 
requirements and recommendations for blood donor eligibility.   
 
This guidance supersedes the document entitled, Implementation of Acceptable Full-Length and 
Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening 
Donors of Blood and Blood Components, dated May 2020.   
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys 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 Agency 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 donor is in good health and that the donor is free from transfusion-
transmitted infections (21 CFR 630.10(a)).  A donors eligibility to donate blood and blood 
components 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 DHQ documents include the following materials:    
 
  Full-Length Donor History Questionnaire (FL-DHQ) 
  Full-Length Donor History Questionnaire User Brochure  includes glossary; describes 
how questions can be administered.  
  Full-Length Donor History Questionnaire Flow Charts  contain follow-up questions as a 
method to obtain additional information 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 Donor History Questionnaire (aDHQ) 
  Abbreviated Donor History Questionnaire User Brochure  includes glossary and 
references; describes which donors may complete the aDHQ questionnaire and how 
questions can be administered.  
  Abbreviated Donor History Questionnaire Flow Charts  contain follow-up questions as a 
method to obtain additional information to further evaluate a potential donors response 
to capture questions.   
  Medication Deferral List  contains a list of medications that may serve as a basis for 
donor deferral. 
  Blood Donor Educational Material  educates the donor about certain risks and 
conditions that are a basis for deferral. 
  References 
 
The FL-DHQ and aDHQ Flowcharts are intended as a resource, and their use is not required if 
the blood establishment has an equivalent method for evaluating responses to the DHQ.  The FL-
DHQ and aDHQ are designed to be implemented together.  In other words, if you choose to 
implement the AABB aDHQ, you should also implement the AABB FL-DHQ, as described in 
the User Brochure.  Both the FL-DHQ and aDHQ are designed for self-administration by the 
donor with follow-up by establishment personnel or may be administered by a health historian.  
 
 
2  Contains Nonbinding Recommendations 
 
III.  RECOGNITION OF DHQ DOCUMENTS  
 
We, FDA, find the DHQ documents, version 4.0 dated May 2023, acceptable for use in screening 
donors of blood and blood components.  These documents are consistent with FDA requirements 
and recommendations for donor eligibility.  
 
Note, the DHQ documents contain questions related to the following donor history factors for 
which we currently do not have requirements or recommendations, including:  cancer; certain 
organ, tissue, or bone marrow transplant; and bone or skin graft.  By recognizing the acceptable 
DHQ documents, we are not requiring or recommending that donors be screened or deferred for 
these factors.  If you choose to implement the acceptable DHQ documents and omit these 
questions, you would still be in compliance with FDA requirements.   
 
While we recognize that the acceptable DHQ documents provide an effective tool for screening 
blood donors, we do not require that you implement these DHQ documents.  You may use any 
FL-DHQ and aDHQ and accompanying materials developed by your establishment that are 
consistent with current FDA requirements and recommendations and, for licensed 
establishments, that are approved by FDA.  These materials may include procedures and wording 
that are different from those in the DHQ documents developed by AABB. 
 
 
IV.  REPORTING IMPLEMENTATION OF ACCEPTABLE DHQ DOCUMENTS 
 
Licensed establishments must report the implementation of the acceptable DHQ documents to 
FDA under 21 CFR 601.12 as follows: 
 
1.  If the acceptable DHQ documents are implemented without modifications and in their 
entirety, as a complete process for administering questions to blood donors, the change 
is considered to be minor.  You must report the change to FDA in your annual report 
under 21 CFR 601.12(d), noting the date the process was implemented.  
 
2.  If the acceptable DHQ documents are implemented in their entirety, but modified by:  
(a) adding additional, more restrictive eligibility criteria that are specific to your 
establishment; or (b) omitting questions related to cancer; organ, tissue, or bone marrow 
transplant; or, bone or skin graft, which FDA has not required or recommended for 
determining donor eligibility, the changes are considered to be minor.  You must report 
the change 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 questions that were 
omitted from your questionnaire.  
 
3.  If the acceptable DHQ 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 flow 
charts, other than changes incorporating donor eligibility criteria that are stricter than 
that required or recommended by FDA.  You must report such changes to FDA in your 
3  Contains Nonbinding Recommendations 
 
annual report under 21 CFR 601.12(d), noting the date the process was implemented and 
describing how you modified the acceptable DHQ documents.  
 
4.  If the acceptable DHQ documents are implemented in their entirety but are modified by 
reformatting any of the acceptable DHQ 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 DHQ 
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 DHQ documents. 
 
5.  If the acceptable DHQ documents are implemented using a new computer-assisted 
interactive interview procedure, this is considered a moderate change.  You must report 
the change as a 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:  For licensed blood establishments already approved to implement a computer-
assisted interactive interview procedure, if the acceptable DHQ documents are 
implemented without modifications, the change is considered to be minor.  You must 
report the 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 DHQ documents that have been modified other than as 
described in sections IV.2-4 of this guidance is considered a major change.  You must 
report the change as a Prior Approval Supplement 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 written standard operating procedure (SOP) describing the donor questions and 
questionnaire process.   
d.  The donor history questionnaires and accompanying document(s).  Please 
highlight the modifications. 
 
Unlicensed blood establishments do not need to report implementation of the acceptable DHQ to 
FDA. 
 
 
V.  FOR MORE INFORMATION 
 
If you have questions regarding this guidance, contact OCOD at the phone numbers or email 
address provided in this guidance.  
4  Contains Nonbinding Recommendations 
 
If you have questions regarding the DHQ documents, contact AABB Regulatory Affairs at 
regulatory@aabb.org, or by phone at 301-907-6977.  
The acceptable DHQ documents are accessible at 
http://www.aabb.org/tm/questionnaires/Pages/dhqaabb.aspx. 
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/regulatory-
information/search-fda-guidance-documents/streamlining-donor-interview-process-
recommendations-self-administered-questionnaires. 
 
6