[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.350]

[Page 738-739]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
--Table of Contents
 
  Subpart E_Additional Requirements for Establishments Described in   
                                 1271.10
 
Sec. 1271.350  Reporting.

    (a) Adverse reaction reports. (1) You must investigate any adverse 
reaction involving a communicable disease related to an HCT/P that you 
made available for distribution. You must report to FDA an adverse 
reaction involving a communicable disease if it:
    (i) Is fatal;
    (ii) Is life-threatening;
    (iii) Results in permanent impairment of a body function or 
permanent damage to body structure; or
    (iv) Necessitates medical or surgical intervention, including 
hospitalization.
    (2) You must submit each report on a Form FDA-3500A to the address 
in paragraph (a)(5) of this section within 15 calendar days of initial 
receipt of the information.
    (3) You must, as soon as practical, investigate all adverse 
reactions that are the subject of these 15-day reports and must submit 
followup reports within 15 calendar days of the receipt of new 
information or as requested by FDA. If additional information is not 
obtainable, a followup report may be required that describes briefly the 
steps taken to seek additional information and the reasons why it could 
not be obtained.
    (4) You may obtain copies of the reporting form (FDA-3500A) from the 
Center for Biologics Evaluation and Research (see address in paragraph 
(a)(5) of this section). Electronic Form FDA-3500A may be obtained at 
http://www.fda.gov/medwatch or at http://www.hhs.gov/forms.
    (5) You must submit two copies of each report described in this 
paragraph to the Center for Biologics Evaluation and Research (HFM-210), 
Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. FDA may waive the requirement for the second 
copy in appropriate circumstances.
    (b) Reports of HCT/P deviations. (1) You must investigate all HCT/P 
deviations related to a distributed HCT/P for which you performed a 
manufacturing step.
    (2) You must report any such HCT/P deviation relating to the core 
CGTP requirements, if the HCT/P deviation occurred in your facility or 
in a facility that performed a manufacturing step for you under 
contract, agreement, or other arrangement. Each report must contain a 
description of the HCT/P deviation, information relevant to the event 
and the manufacture of the HCT/P involved, and information on all 
follow-up actions that have been or will be taken in response to the 
HCT/P deviation (e.g., recalls).
    (3) You must report each such HCT/P deviation that relates to a core 
CGTP requirement on Form FDA-3486 available at http://www.fda.gov/cber/
biodev/bpdrform.pdf, within 45 days of the discovery of the event either 
electronically at http://www.fda.gov/cber/biodev/biodevsub.htm or by 
mail to the Director, Office of Compliance and Biologics Quality, Center 
for Biologics Evaluation and Research (HFM-600), 1401

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Rockville Pike, suite 200N, Rockville, MD 20852-1448.