[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR630.6]

[Page 94-95]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 630_GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD 
 
Sec. 630.6  Donor notification.

    (a) Notification of donors. You, an establishment that collects 
blood or blood components, 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 Sec. 610.41 of this chapter; or who has been 
determined not to be suitable as a donor based on suitability criteria 
under Sec. 640.3 or Sec. 640.63 of this chapter. You must attempt to 
obtain the results of supplemental testing required under Sec. 
610.40(e) of this chapter prior to notifying a donor of the deferral. If 
notification occurs prior to receipt of such results, you must also 
notify a deferred donor of the results of the supplemental testing. You 
must notify a donor as described in paragraph (b) of this section.
    (b) Content of notification. You must provide the following 
information to a donor deferred or determined not to be suitable as a 
donor as described in paragraph (a) of this section:
    (1) That the donor is deferred or determined not to be suitable for 
donation and the reason for that decision;
    (2) Where appropriate, the types of donation of blood or blood 
components that the donor should not donate in the future;
    (3) Where applicable, the results of tests for evidence of infection 
due to communicable disease agent(s) that were a basis for deferral 
under Sec. 610.41 of this chapter, including results of supplemental 
(i.e., additional, more specific) tests as required in Sec. 610.40(e) 
of this chapter; and,
    (4) Where appropriate, information concerning medical followup and 
counseling.
    (c) Time period for notification. 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 as described in 
paragraph (a) of this section. You must document that you have 
successfully notified the donor or when you are unsuccessful that you 
have made reasonable attempts to notify the donor.
    (d) Autologous donors. (1) You also must provide the following 
information to the referring physician of an autologous donor who is 
deferred based on the results of tests for evidence of infection with a 
communicable disease agent(s) as described in paragraph (a) of this 
section:
    (i) 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 Sec. 610.41 of this chapter, and the reason 
for that decision;
    (ii) Where appropriate, the types of donation of blood or blood 
components that the autologous donor should not donate in the future; 
and

[[Page 95]]

    (iii) The results of tests for evidence of infection due to 
communicable disease agent(s), that were a basis for deferral under 
Sec. 610.41 of this chapter, including results of supplemental (i.e., 
additional, more specific) tests as required in Sec. 610.40(e) of this 
chapter.
    (2) You must make reasonable attempts to notify the autologous 
donor's referring physician within 8 weeks after determining that the 
autologous donor is deferred as described in paragraph (a) of this 
section. You must document that you have successfully notified the 
autologous donor's referring physician or when you are unsuccessful that 
you have made reasonable attempts to notify the physician.