Guidance for Industry 
 
 
Donors of Blood and Blood Components: 
Notification of Donor Deferral 
 
Small Entity Compliance Guide 
 
 
 
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 written comments on this guidance at anytime to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.  Submit electronic comments to http://www.regulations.gov.  You should 
identify all comments with the Docket no. FDA-1998-N-1016 (formerly Docket no. 1998N-
0607).   
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD), (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, or by calling 1-800-835-4709 or 301-827-1800, or email ocod@fda.hhs.gov, or from the 
Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm. 
 
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 2011  Contains Nonbinding Recommendations 
Table of Contents 
 
I.  INTRODUCTION.............................................................................................................1 
II.  BACKGROUND...............................................................................................................2 
III.  NOTIFICATION REQUIREMENTS............................................................................2 
A.  What are the Notification Requirements under  630.6?..................................2 
B.  How Should You Notify Donors under  630.6?................................................3 
C.  Are You Required to Notify Donors of the Results of Supplemental Tests 
under  630.6?.......................................................................................................4 
D.  What are the Notification Requirements as to Autologous Donors under  
630.6?......................................................................................................................4 
IV.  RECORDKEEPING REQUIREMENTS.......................................................................5 
V.  STANDARD OPERATING PROCEDURES.................................................................5 
i  Contains Nonbinding Recommendations 
Guidance for Industry 
 
Donors of Blood and Blood Components:  Notification of 
Donor Deferral - Small Entity Compliance Guide 
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to 
discuss an alternative approach, contact the appropriate FDA staff.  If you cannot 
identify the appropriate FDA staff, call the appropriate number listed on the title page of 
this guidance. 
 
 
I.  INTRODUCTION 
 
The Food and Drug Administration (FDA) has prepared this guidance in accordance with 
section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public 
Law 104-121).  According to the Small Business Administration, a small business 
within the blood industry is an enterprise with $10 million in average annual receipts.1  
This guidance is intended to help you, a small entity that collects blood or blood 
components for transfusion or for further manufacturing (blood or blood components), 
better understand and comply with the regulatory framework set forth in Title 21 Code of 
Federal Regulations 630.6 (21 CFR 630.6).  This provision requires you to make 
reasonable attempts to notify donors, including autologous donors, that they are deferred 
based on the results of tests for evidence of infection with a communicable disease 
agent(s) as required by 21 CFR 610.41, or determined not to be suitable for donation due 
to failure to satisfy suitability criteria under 21 CFR 640.3 or 21 CFR 640.63.  This 
provision also requires you to notify the referring physician of an autologous donor when 
the autologous donor is deferred based on tests for evidence of infection with a 
communicable disease agent(s). 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe 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 http://www.sba.gov/sites/default/files/Size_Standards_Table.pdf (accessed May 26, 2011).   
1  Contains Nonbinding Recommendations 
II.  BACKGROUND 
 
This guidance document provides information regarding 21 CFR 630.6 ( 630.6)2, which 
requires establishments that collect blood or blood components to make reasonable 
attempts to notify all donors, including autologous donors, that they are deferred from 
further donations based on results of tests for evidence of infection with a communicable 
disease agent(s) under 21 CFR Part 610 or determined not to be suitable for donation 
based on failure to satisfy suitability criteria under 21 CFR Part 640.  We note that while 
this guidance is specifically designed to be of use to small entities that collect blood or 
blood components, the requirements and recommendations in this guidance are 
applicable to all entities that collect blood or blood components, regardless of size.     
 
 
III.  NOTIFICATION REQUIREMENTS 
 
A.  What are the Notification Requirements under  630.6? 
 
Under  630.6(a), you must make reasonable attempts to notify any donor, 
including an autologous donor, who has been deferred based on the results of tests 
for evidence of infection with a communicable disease agent(s) as required by  
21 CFR 610.41 ( 610.41) or who has been determined not to be suitable as a 
donor based on suitability criteria under 21 CFR 640.3 or 21 CFR 640.63.  In 
addition, under  630.6(d), you also must make reasonable attempts to notify an 
autologous donors referring physician when an autologous donor has been 
deferred.  These requirements are designed to reduce the risk of transmission of 
communicable disease from the use of blood and blood components.  You are not 
required to use these notification procedures to notify donors that you have 
voluntarily deferred for medical reasons beyond those required in  630.6 (66 FR 
31165 at 31167). 
 
Under  630.6(b), you must provide the following information to a donor that was 
deferred or determined not to be suitable for donation:  
 
  That the donor is deferred or determined not to be suitable for donation and 
the reason for that decision; 
  Where appropriate, the types of donation of blood or blood components that 
the donor should not donate in the future; 
  Where applicable, the results of tests for evidence of infection due to 
communicable disease agent(s) that were a basis for deferral under  610.41,  
                                                 
2 FDA published the final rule on the general requirements for donor notification in the Federal Register of 
June 11, 2001 (66 FR 31165).  We note that in the Federal Register of November 8, 2007, FDA proposed 
modifications to some of the requirements described in this guidance in a proposed rule entitled 
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further 
Manufacturing Use (72 FR 63416).    
2  Contains Nonbinding Recommendations 
including results of supplemental (i.e., additional, more specific) tests as 
required in  610.40(e); and 
  Where appropriate, information concerning medical followup and counseling.   
 
B.  How Should You Notify Donors under  630.6? 
 
Under  630.6(c), you must make reasonable attempts to notify the donor within 8 
weeks after determining that the donor is deferred or determined not to be suitable 
for donation.  You have the flexibility to choose the manner in which you notify 
the donor, including the method by which you protect donor confidentiality.  You 
may choose to notify:  (1) in person at the time of the actual deferral; (2) in person 
at the donors first return visit; (3) by phone; or (4) by mail (e.g., regular mail, 
certified mail, registered mail, etc.).  You also may notify donors with generic 
letters, provided that this method of notification provides all of the required 
information.  However, you may need to supplement a generic letter on a case-by-
case basis with information specific to the donor.  Alternatively, you may also 
choose to send letters to donors requesting that they return for direct notification 
(66 FR 31165 at 31170).  In any event, the personnel performing this activity 
must be adequately trained as required in 21 CFR 606.20 ( 606.20).   
 
You must make reasonable attempts to contact the donor who has been deferred 
until you succeed in notifying the donor or until it is clear that further attempts 
will not be successful in accordance with your written Standard Operating 
Procedures (SOPs) ( 606.100(b)(20)).  If one method of notifying the donor is 
unsuccessful, you may need to use a different method of notification.  For 
example, if you mail a donor notification letter and it is returned unopened, you 
may need to use a different method of notification, such as phone the donor and 
either notify the donor at that time or ask for a correct address in order to resend 
the letter.  Alternatively, you could also try checking the donors record (see  
 606.160(b)(1)(x)) to verify the donors address or searching the local phone 
book or the internet to verify the correct address and then resend the notification 
letter (66 FR 31165 at 31170).   
 
FDA is aware of varying State requirements concerning notification of State 
health authorities of a donors positive test results, as opposed to a donors 
deferral.  Such State laws require that the collecting establishment notify the State 
of certain communicable disease test results.  The State may then notify the 
donor, but not always.  Our requirements prescribe that you make reasonable 
attempts to notify the donor who has been deferred directly of all test results that 
were the basis for deferral and that the donor be given information, where 
appropriate, concerning medical followup and counseling.  The requirements 
contained in  630.6 are in addition to, and do not conflict with, State 
requirements (66 FR 31165 at 31168).   
3  Contains Nonbinding Recommendations 
 
C.  Are You Required to Notify Donors of the Results of Supplemental 
Tests under  630.6? 
 
The regulations require that the donor who has been deferred be notified of both 
the screening and supplemental (i.e., additional, more specific) test results  
( 630.6(a)).  As a general matter, to minimize the impact on small entities while 
continuing to protect the public health, the agency does not require donor 
notification until after the results of the approved supplemental testing are 
available, where it is reasonable to assume that these test results will be available 
within the 8-week notification time frame (66 FR 31165 at 31171 & 31173).  
When the approved supplemental test results will not be available within the 8-
week time period, you must make reasonable attempts to notify the donor who has 
been deferred based on the results of screening tests for evidence of infection with 
a communicable disease agent(s) ( 630.6(a)).  Note that in such instances, you 
would then be required to notify the donor of the results of the supplemental 
testing when they become available ( 630.6(a)).  
 
Because an approved supplemental test for human T-lymphotropic virus (HTLV), 
types I and II, and anti-hepatitis B core (anti-HBc) is not available at this time, 
you are not required to notify or defer donors with a single reactive test result for 
HTLV, types I and II, or anti-HBc.  We believe it is appropriate that blood 
establishments not be required to notify donors after a reactive screening test on 
the first occasion due to the high rate of false reactivity in low risk blood bank 
settings.  However, under  610.40(h)(1), the allogeneic donation that tests 
reactive must not be shipped or transfused, even though the donor remains in the 
donor pool until the donor tests reactive on a second occasion (66 FR 31165 at 
31169).  We note that it remains our intent that if licensed supplemental tests for 
HTLV, types I and II, or anti-HBc are approved, you would be required to defer 
donors after a single reactive test result regardless of the results of the 
supplemental (additional, more specific) tests, and to notify the donor of both the 
screening and supplemental test results as prescribed in  630.6(b) (66 FR 31165 
at 31169).    
 
D.  What are the Notification Requirements as to Autologous Donors 
under  630.6?  
 
In recognition of how an autologous donation may be a medically ordered 
procedure, you also must make reasonable attempts to notify the autologous 
donors referring physician that the donor has been deferred based on test results 
and the reason for that decision under  630.6(d).   
 
You must make reasonable attempts to notify the autologous donor and his or her 
referring physician within 8 weeks after determining that the donor is deferred or 
determined not to be suitable for donation ( 630.6(c) and  630.6(d)(2)).  The 
information you must provide to the autologous donor under  630.6(a) is the 
4  Contains Nonbinding Recommendations 
same information that you are required to provide to an allogeneic donor and is 
described in section III.A. of this guidance document.  In addition, under  
 630.6(d)(1), you must provide the following information to the autologous 
donors referring physician:  
 
  Information that the autologous donor is deferred based on the results of tests 
for evidence of infection due to communicable disease agent(s), as required 
under  610.41 and the reason for that decision;  
  Where appropriate, the types of donation of blood or blood components that 
the autologous donor should not donate in the future; and  
  The results of tests for evidence of infection due to communicable disease 
agent(s) that were a basis for deferral under  610.41, including results of 
supplemental (i.e., additional, more specific) tests as required under  
 610.40(e).    
 
 
IV.  RECORDKEEPING REQUIREMENTS   
 
You are required to obtain and keep a record of an address where the donor may be 
reached within 8 weeks after donation ( 606.160(b)(1)(x)).  Under  606.160(b)(1)(ix), 
you also must document that you have successfully notified a donor who has been 
deferred, including an autologous donor, or when you are unsuccessful, that you have 
made reasonable attempts to notify the donor if the initial attempt at notification fails.  
Furthermore, under  606.160(b)(1)(xi), you must maintain records of notification of the 
referring physician of an autologous donor who has been deferred, including appropriate 
followup if the initial notification attempt fails.   
 
 
V.  STANDARD OPERATING PROCEDURES 
 
As required in  606.100(b)(20), you must prepare written SOPs for donor notification 
and autologous donor referring physician notification, including procedures for the 
appropriate followup if the initial attempt at notification fails.  You should also consider 
writing your SOPs to include instructions for the documentation of reasonable attempts, 
including unsuccessful attempts, made to contact donors who have been deferred and the 
referring physician of autologous donors who have been deferred.  Furthermore, you 
should consider including instructions for the documentation of the reason for the 
deferral.  We note that under  606.100(b), these SOPs must be maintained and must 
include all steps to be followed in the collection, processing, compatibility testing, 
storage, and distribution of blood and blood components.  We further note that these 
SOPs must be available to personnel for use in the areas where these procedures are 
performed ( 606.100(b)). 
 
  
 
 
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