The information collection burden in final Sec.  630.40 resulting
from the redesignation of Sec.  630.6 has been approved under OMB
control number 0910-0116. Under final Sec.  630.40, FDA considers the
changes in text from ``communicable disease'' to ``relevant
transfusion-transmitted infection(s)'', ``suitable'' to ``eligible'',
and ``suitability'' to ``eligibility'', to be technical amendments that
do not confer any new burden. FDA is not calculating the information
collection burden under Sec.  606.145(d) for the additional requirement
that establishments that collect blood or blood components make
reasonable attempts to notify any donor whose donated platelets have
been determined to be contaminated with an organism that is identified
as likely to be associated with a bacterial infection that is
endogenous to the bloodstream of the donor, because establishments
perform this activity as a usual and customary business practice and
there is minimal new information collection burden for this
requirement. The third party disclosure burden under Sec.
630.30(b)(4), is covered under Sec.  630.40.
    Under Sec.  640.21(c), FDA requires the establishments to label
donations received from platelet donors who have recently ingested a
drug that adversely affects platelet function to identify the ingested
drug. FDA is not calculating the information collection burden for this
regulation as there is minimal additional burden for this requirement
because establishments collecting blood and blood components perform
this activity as a usual and customary business practice.
    The collections of information under Sec.  640.120 has been
approved under OMB control number 0910-0338. FDA is not calculating
information collection burden for Sec.  640.120, because the changes
that were made will not have an impact on the current burden estimated
for industry.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web site after this document
publishes in the Federal Register.)

1. HHS, Blood Action Plan, FDA/CBER, July 1997.
2. U.S. House of Representatives, Committee on Government Reform and
Oversight, Subcommittee on Human Resources and Intergovernmental
Relations, ``Protecting the Nation's Blood Supply from Infectious
Agents: The Need for New Standards to Meet New Threats,'' August 2,
1996, http://www.gpo.gov/fdsys/pkg/CRPT-104hrpt746/html/CRPT-104hrpt746.htm.
3. U.S. General Accounting Office, ``Blood Supply: FDA Oversight and
Remaining Issues of Safety,'' February 25, 1997, http://www.gao.gov/products/PEMD-97-1.
4. Stramer, S. L., F. B. Hollinger, L. Katz, et al., ``Emerging
Infectious Disease Agents and Their Potential Threat to Transfusion
Safety,'' Transfusion, August 2009; 49:1S-29S.
5. Stramer, S. L. and R. Y. Dodd, ``Transfusion-Transmitted Emerging
Infectious Diseases: 30 Years of Challenges and Progress,''
Transfusion, October 2013, 53:2375-2383.
6. FDA, ``Guidance for Industry: Implementation of Acceptable Full-
Length Donor History Questionnaire and Accompanying Materials for
Use in Screening Donors of Blood and Blood Components,'' October
2006, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073445.htm.
7. FDA, ``Guidance for Industry: Implementation of an Acceptable
Full-Length and Abbreviated Donor History Questionnaires and
Accompanying Materials for Use in Screening Donors of Source
Plasma,'' February 2013, http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/UCM341088.pdf.
8. FDA, ``Guidance for Industry: Implementation of an Acceptable
Abbreviated Donor History Questionnaire and Accompanying Materials
for Use in Screening Frequent Donors of Blood and Blood
Components,'' May 2013, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm351107.htm.
9. ``Transmission of HIV Possibly Associated with Exposure of Mucous
Membrane to Contaminated Blood,'' Morbidity and Mortality Weekly
Report, July 11, 1997; 46(27):620-623.
10. FDA Memorandum: ``Revised Recommendations for the Prevention of
Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood
Products,'' April 1992, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM062834.pdf.
11. FDA, ``Guidance for Industry: Revised Preventive Measures to
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood
and Blood Products,'' May 2010, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/UCM213415.pdf.
12. Dumont, L. J., S. Kleinman, J. R. Murphy, et al., ``Screening of
Single-Donor Apheresis Platelets for Bacterial Contamination: The
PASSPORT Study Results,'' Transfusion, March 2010; 50:589-599.
13. Yomtovian, R. A. and M. Brecher, ``pH and Glucose Testing of
Single-Donor Apheresis Platelets Should be Discontinued in Favor of
a More Sensitive Detection Method,'' Transfusion 2005; 4:646-648.
14. Jacobs, M. R., C. E. Good, H. M. Lazarus, et al., ``Relationship
Between Bacterial Load, Species Virulence, and Transfusion Reaction
with Transfusion of Bacterially Contaminated Platelets,'' Clinical
Infectious Disease, 2008; 46:1214-1220.
15. FDA, ``Fatalities Reported to FDA Following Blood Collection and
Transfusion: Annual Summary for Fiscal Year 2012,'' http://
www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/
ReportaProblem/

TransfusionDonationFatalities/ucm346639.htm.
16. College of American Pathologists, ``Commission on Laboratory
Accreditation: Laboratory Accreditation Program, Transfusion
Medicine Checklist,'' September 27, 2007.
17. AABB Association Bulletin #03-12, ``Further Guidance on Methods
to Detect Bacterial Contamination of Platelet Components,'' October
2003.\2\
---------------------------------------------------------------------------

    \2\ There is a new version of this document that continues to
implement this standard.
---------------------------------------------------------------------------

18. Eder, A. F. and M. Goldman, ``How Do I Investigate Septic
Transfusion Reactions and Blood Donors with Culture-Positive
Platelet Donations?'' Transfusion, August 2011; 51:1662-1668.
19. Gold, J. S., S. Bayar, and R. R. Salem, ``Association of
Streptococcus bovis Bacteremia with Colonic Neoplasia and
Extracolonic Malignancy,'' Archives of Surgery, 2004; 139(7):760-
765.
20. AABB ``Public Conference: Secondary Bacterial Screening of
Platelet Components,'' July 17, 2012.
21. Domen, R. E., I. D. Grewal, N. V. Hirschler, et al., ``An
Evaluation of the Need for Shared Blood Donor Deferral Registries,''
International Journal for Quality in Health Care, 1997; 9:35-41.
22. Ellis, F. R., L. I. Friedman, B. F. Wirak, et al., ``A
Computerized National Blood Donor Deferral Register,'' The Journal
of the American Medical Association, 1975; 232(7):722-724.
23. Plasma Protein Therapeutics Association, ``National Donor
Deferral Registry (NDDR)''
24. FDA, ``Guidance for Industry: Use of Serological Tests to Reduce
the Risk of Transmission of Trypanosoma cruzi Infection in Whole
Blood and Blood Components Intended for Transfusion,'' December
2010, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm235855.htm.
25. Blood Products Advisory Committee, 94th meeting, April 1, 2009,
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM155628.pdf.
26. Blood Products Advisory Committee, 67th meeting, September 15,
2000, http://www.fda.gov/ohrms/dockets/ac/00/agenda/3649a1.pdf.
27. Ortel, T. L., ``Antiphospholipid Syndrome: Laboratory Testing
and Diagnostic Strategies,'' American Journal of Hematology, 2012;
87:S75-S81.
28. FDA, ``Guidance for Industry: Donor Screening for Antibodies to
HTLV-II,'' August 1997, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm170786.htm.
29. FDA, ``Guidance for Industry: Requalification Method for Reentry
of Blood Donors Deferred Because of Reactive Test Results for
Antibody to Hepatitis B Core Antigen (Anti-HBc),'' May 2010, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM210268.pdf.
30. FDA Memorandum: ``Recommendations to Decrease the Risk of
Transmitting Acquired Immune Deficiency Syndrome (AIDS) from Blood
Donors,'' March 24, 1983.
31. AABB Association Bulletin #03-14, ``Deferral for Risk of
Leishmaniasis Exposure,'' October 10, 2003.
32. Bai, N., ``Donor Fatigue. The Red Cross Has Banned Chronic
Fatigue Syndrome Sufferers from Giving Blood. But Does a Virus
Really Cause the Disease?'' Scientific American, July 2011;
305(1):26.
33. Young, S., A. Fink, S. Geiger, et al., ``Community Blood Donors'
Knowledge of Anemia and Design of a Literacy-Appropriate Educational
Intervention,'' Transfusion, January 2010; 50:75-79.
34. FDA, ``Guidance for Industry: Recommendations for Blood
Establishments: Training of Back-Up Personnel, Assessment of Blood
Donor Suitability and Reporting Certain Changes to an Approved
Application,'' November 2010, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM190373.pdf.
35. FDA, ``Guidance for Industry: Assessing Donor Suitability and
Blood and Blood Product Safety in Cases of Known or Suspected West
Nile Virus Infection,'' June 2005, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080286.pdf.
36. FDA, ``Guidance for Industry: Revised Recommendations for the
Assessment of Donor Suitability and Blood Product Safety in Cases of
Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to
SARS,'' September 2003, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080301.pdf.
37. FDA, Draft ``Guidance for Industry: Precautionary Measures to
Reduce the Possible Risk of Transmission of Zoonoses by Blood and
Blood Products from Xenotransplantation Product Recipients and Their
Intimate Contacts,'' February 2002, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080375.pdf.
38. FDA Memorandum: ``Deferral of Blood and Plasma Donors Based on
Medications,'' July 28, 1993, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM062813.pdf.
39. FDA, ``Guidance for Industry: Recommendations for Assessment of
Donor Suitability and Blood and Blood Product Safety in Cases of
Possible Exposure to Anthrax,'' October 2001, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062638.pdf.
40. HHS, NIH ``The Seventh Report of the Joint National Committee on
Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure,'' August 2004.
41. Trouern-Trend, J. J., R. G. Cable, S. J. Badon, et al., ``A
Case-Controlled Multicenter Study of Vasovagal Reactions in Blood
Donors: Influence of Sex, Age, Donation Status, Weight, Blood
Pressure, and Pulse,'' Transfusion, March 1999; 39:316-320.
42. Wiltbank, T. B., G. F. Giordano, H. Kamel, et al., ``Faint and
Prefaint Reactions in Whole-Blood Donors: An Analysis of Predonation
Measurements and Their Predictive Value,'' Transfusion, September
2008; 48:1799-1808.
43. Blood Product Advisory Committee, 92nd meeting, September 10,
2008, http://www.fda.gov/ohrms/dockets/ac/08/agenda/2008-4379A(draft).pdf.
44. Blood Product Advisory Committee, 98th meeting, July 27, 2010,
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM218990.pdf.
45. HHS, U.S. Public Health Service, Advisory Committee on Blood
Safety and Availability, 35th meeting, December 17, 2008, http://www.hhs.gov/ash/bloodsafety/advisorycommittee/minutes/dec2008_minutes.pdf.
46. FDA, ``Public Workshop: Hemoglobin Standards and Maintaining
Adequate Iron Stores in Blood Donors,'' November 8-9, 2011, http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm268757.htm.
47. Weber, J. P., P. C. Walsh, C. A. Peters, et al., ``Effect of
Reversible Androgen Deprivation on Hemoglobin and Serum
Immunoreactive Erythropoietin in Men,'' American Journal of
Hematology, March 1991; 36:190-194.
48. Ryan, D. H., Chapter 2. Examination of Blood Cells. In: Prachal,
J. T., K. Kaushansky, M. A. Lichtman, T. J. Kipps, and U. Seligsohn,
eds. Williams Hematology. 8th ed. New York: McGraw-Hill; 2010.
49. Cable, R. G., W. R. Steele, R. S. Melmed, et al., ``The
Difference Between Fingerstick and Venous Hemoglobin and Hematocrit
Varies by Sex and Iron Stores,'' NHLBI Retrovirus Epidemiology Donor
Study-II (REDS-II). Transfusion, May 2012; 52:1031-1040.
50. Cable, R. G., S. A. Glynn, J. E. Kiss, et al., ``Iron Deficiency
in Blood Donors: the REDS-II Donor Iron Status Evaluation (RISE)
Study,'' NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II).
Transfusion, April 2012; 52:702-711.
51. LeBlond, R. F., D. D. Brown, and R. L. DeGowin, Chapter 4,
``Vital Signs, Anthropometric Data, and Pain,'' DeGowin's Diagnostic
Examination, 9th ed. New York: McGraw-Hill; 2009.

52. Blood Products Advisory Committee, 100th meeting, April 28-29,
2011,  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM251509.pdf.
53. FDA, ``Guidance for Industry: Recommendations for Collecting Red
Blood Cells by Automated Apheresis Methods,'' January 2001.
Technical Correction February 2001, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm076756.htm.
54. FDA, ``Guidance for Industry: Variances for Blood Collection
From Individuals with Hereditary Hemochromatosis,'' August 2001,
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080393.pdf.
55. Tan, L., M. K. Khan, and J. C. Hawk III, ``Use of Blood
Therapeutically Drawn From Hemochromatosis Patients,'' Transfusion,
September 1999; 39:1018-1026.
56. HHS Memorandum: Summary of the Advisory Committee Meeting on
Blood Safety and Availability Meeting, April 29-30, 1999, http://www.hhs.gov/ash/bloodsafety/summaries/sumapr99.html.
57. Jeffrey, G. and P. C. Adams, ``Blood from Patients with
Hereditary Hemochromatosis-a Wasted Resource?'' Transfusion, June
1999; 39:549-550.
58. Shaz, B. H., D. A. Kessler, C. A. Hillyer, et al., ``Evaluating
the Role of Blood Collection Centers in Public Health: A Status
Report,'' Transfusion Medicine Reviews, January 2012; 26:58-67.
59. Kessler, D. A., R. Davey, J. Wilson, et al., ``A Financial
Analysis of Collecting Blood from Hereditary Hemochromatosis
Patients under Variance,'' Transfusion, 2003; 43: Abstract
Supplement, 167A:AP112.
60. McPherson, R. A., ``Specific Proteins'' Henry's Clinical
Diagnosis and Management by Laboratory Methods, 2007; (21): 31-242,
and 1409.
61. Laubach, J., P. Richardson, and K. Anderson, ``Multiple
Myeloma,'' Annual Reviews of Medicine, February 2011; 62:249-264.
62. FDA, ``Guidance for Industry: Informed Consent Recommendations
for Source Plasma Donors Participating in Plasmapheresis and
Immunization Programs,'' June 2007, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm062905.pdf.
63. FDA Memorandum: ``Donor Deferral Due to Red Blood Cell Loss
During Collection of Source Plasma by Automated Plasmapheresis,''
December 4, 1995, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/OtherRecommendationsforManufacturers/MemorandumtoBloodEstablishments/UCM062626.pdf.
64. FDA, ``Guidance for Industry and FDA Review Staff: Collection of
Platelets by Automated Methods,'' December 2007, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073382.htm.
65. Laub, R., S. Baurin, D. Timmerman, et al., ``Specific Protein
Content of Pools of Plasma for Fractionation from Different Sources:
Impact of Frequency of Donations,'' Vox Sanguinis: The International
Journal of Transfusion Medicine, October 2010; 99:220-231.
66. Lewis, S. L., S. G. Kutvirt, P. N. Bonner, et al., ``Plasma
Proteins and Lymphocyte Phenotypes in Long-Term Plasma Donors,''
Transfusion, July 1994; 34:578-585.
67. FDA Memorandum: ``Revised Recommendations for Testing Whole
Blood, Blood Components, Source Plasma and Source Leukocytes for
Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),'' August
5, 1993, http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/otherrecommendationsformanufacturers/memorandumtobloodestablishments/ucm062811.pdf.
68. Katz, L., K. Palmer, E. McDonnell, et al., ``Frequent
Plateletpheresis Does Not Clinically Significantly Decrease Platelet
Counts in Donors,'' Transfusion, September 2007; 47:1601-1606.
69. Lazarus, E. F., J. Browning, J. Norman, et al., ``Sustained
Decreases in Platelet Count Associated with Multiple, Regular
Plateletpheresis Donations,'' Transfusion, June 2001; 41:756-761.
70. Page, E. A., J. F. Harrison, E. J. Jadlow, et al., ``Impairment
of Short-Term Memory Associated with Low Iron Stores in a Volunteer
Multidose Plateletpheresis Donor,'' Transfusion Medicine, October
2008; 18:312-314.
71. Page, E. A., J. E. Coppock, and J. F. Harrsion, ``Study of Iron
Stores in Regular Plateletphereis Donors,'' Transfusion Medicine,
February 2010; 20:22-29.
72. Macher, S., S. Sipurzynski-Budra[beta], K. Rosskopf, et al.,
``Influence of Multicomponent Apheresis on Donors' Haematological
and Coagulation Parameters, Iron Storage and Platelet Function,''
Vox Sanguinis: The International Journal of Transfusion Medicine,
October 2012; 103:194-200.
73. U.S. General Accounting Office, Report to Chairman, Subcommittee
on Human Resources, Committee on Government Reform and Oversight,
House of Representatives, ``Blood Plasma Safety: Plasma Product
Risks Are Low if Good Manufacturing Practices Are Followed,''
September 9, 1998, http://www.gao.gov/archive/1998/he98205.pdf.
74. Plasma Protein Therapeutics Association, Quality Standards of
Excellence, Assurance and Leadership (QSEAL), Certification Program.
75. FDA Proposed Rule: Safety Reporting Requirements for Human Drug
and Biologicals (68 FR 12406, March 14, 2003), http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5204.pdf.
76. FDA, Exceptions and Alternative Procedures Approved Under 21 CFR
640.120, http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/ExceptionsandAlternativeProcedures/default.htm.
77. Final Regulatory Impact Analysis, Final Regulatory Flexibility
Analysis, and Unfunded Mandates Reform Act Analysis for Requirements
for Blood and Blood Components Intended for Transfusion or for
Further Manufacturing Use, http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 606

    Blood, Labeling, Laboratories, Reporting and recordkeeping
requirements.

21 CFR Parts 610 and 660

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 630

    Blood, Reporting and recordkeeping requirements.

21 CFR Part 640

    Blood, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 820

    Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR Chapter I is amended as follows:

PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD
COMPONENTS

0
1. The authority citation for 21 CFR part 606 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371,
374; 42 U.S.C. 216, 262, 263a, 264.

0
2. In Sec.  606.3, revise paragraphs (a) and (c) to read as follows:

Sec.  606.3  Definitions.

* * * * *
    (a) Blood means a product that is a fluid containing dissolved and
suspended elements which was collected from the vascular system of a
human.
* * * * *
    (c) Blood component means a product containing a part of human
blood

separated by physical or mechanical means.
* * * * *

Sec.  606.40  [Amended]

0
3. In Sec.  606.40(a)(1), remove ``suitability'' and add in its place
``eligibility''.
0
4. Amend Sec.  606.100 as follows:
0
a. Revise paragraph (b) introductory text;
0
b. In paragraph (b)(1), remove ``suitability'' and add in its place
``eligibility'';
0
c. Revise paragraph (b)(20); and
0
d. Add paragraphs (b)(21) and (b)(22).
    The revisions and additions read as follows:

Sec.  606.100  Standard operating procedures.

* * * * *
    (b) Establishments must establish, maintain, and follow written
standard operating procedures for all steps in the collection,
processing, compatibility testing, storage, and distribution of blood
and blood components for allogeneic transfusion, autologous
transfusion, and further manufacturing purposes; for all steps in the
investigation of product deviations related to Sec.  606.171; and for
all steps in recordkeeping related to current good manufacturing
practice and other applicable requirements and standards. Such
procedures must be available to the personnel for use in the areas
where the procedures are performed. The written standard operating
procedures must include, but are not limited to, descriptions of the
following, when applicable:
* * * * *
    (20) Procedures for donor deferral as prescribed in Sec.  610.41 of
this chapter.
    (21) Procedures for donor notification and notification of the
referring physician of an autologous donor, including procedures for
the appropriate followup if the initial attempt at notification fails,
as prescribed in Sec.  630.40 of this chapter.
    (22) Procedures to control the risks of bacterial contamination of
platelets, including all steps required under Sec.  606.145.
* * * * *

Sec.  606.110  [Amended]

0
5. Amend Sec.  606.110 as follows:
0
a. In paragraph (a), remove ``qualified licensed physician'' and add in
its place ``responsible physician'' and remove ``certified in writing''
and add in its place ``determined and documented''; and
0
b. In paragraph (b), remove ``640.63'' and add in its place ``630.10,
630.15''.

Sec.  606.121  [Amended]

0
6. Amend Sec.  606.121 as follows:
0
a. In paragraph (c)(11) remove ``communicable disease agents'' and add
in its place ``relevant transfusion-transmitted infections''; and
remove ``Sec. Sec.  610.40(i) and 640.65(b)'' and add in its place
``Sec.  640.65(b)'';
0
b. In paragraph (c)(12) remove ``communicable disease agent(s)'' and
add in its place ``relevant transfusion-transmitted infection(s)'';
0
c. In paragraphs (h)(2) and (3), remove ``640.5(a), (b),'' and add in
its place ``640.5(b)''; and
0
d. In paragraph (i)(5), remove ``suitability'' and add in its place
``eligibility''; remove ``Sec.  640.3'' and add it its place ``Sec.
630.10''; and remove ``communicable disease agents'' and add in its
place ``relevant transfusion-transmitted infections''.

Sec.  606.122  [Amended]

0
7. In Sec.  606.122(e), remove ``communicable disease agents'' and add
in its place ``relevant transfusion-transmitted infections''.
0
8. Add Sec.  606.145 to subpart H to read as follows:

Sec.  606.145  Control of bacterial contamination of platelets.

    (a) Blood collection establishments and transfusion services must
assure that the risk of bacterial contamination of platelets is
adequately controlled using FDA approved or cleared devices or other
adequate and appropriate methods found acceptable for this purpose by
FDA.
    (b) In the event that a blood collection establishment identifies
platelets as bacterially contaminated, that establishment must not
release for transfusion the product or any other component prepared
from the same collection, and must take appropriate steps to identify
the organism.
    (c) In the event that a transfusion service identifies platelets as
bacterially contaminated, the transfusion service must not release the
product and must notify the blood collection establishment that
provided the platelets. The transfusion service must take appropriate
steps to identify the organism; these steps may include contracting
with the collection establishment or a laboratory to identify the
organism. The transfusion service must further notify the blood
collection establishment either by providing information about the
species of the contaminating organism when the transfusion service has
been able to identify it, or by advising the blood collection
establishment when the transfusion service has determined that the
species cannot be identified.
    (d) In the event that a contaminating organism is identified under
paragraph (b) or (c) of this section, the collection establishment's
responsible physician, as defined in Sec.  630.3(i) of this chapter,
must determine whether the contaminating organism is likely to be
associated with a bacterial infection that is endogenous to the
bloodstream of the donor, in accordance with a standard operating
procedure developed under Sec.  606.100(b)(22). This determination may
not be further delegated.

0
9. In Sec.  606.160, revise paragraphs (b)(1)(ix) through (xi), and (e)
to read as follows:

Sec.  606.160  Records.

* * * * *
    (b) * * *
    (1) * * *
    (ix) The donor's postal address provided at the time of donation
where the donor may be contacted within 8 weeks after donation.
    (x) Records of notification of donors deferred or determined not to
be eligible for donation, including appropriate followup if the initial
attempt at notification fails, performed under Sec.  630.40 of this
chapter.
    (xi) Records of notification of the referring physician of a
deferred autologous donor, including appropriate followup if the
initial attempt at notification fails, performed under Sec.  630.40 of
this chapter.
* * * * *
    (e) Records of deferred donors. (1) Establishments must maintain at
each location a record of all donors found to be ineligible or deferred
at that location so that blood and blood components from an ineligible
donor are not collected and/or released while the donor is ineligible
or deferred; and
    (2) Establishments must maintain at all locations operating under
the same license or under common management a cumulative record of
donors deferred from donation under Sec.  610.41 of this chapter
because their donation tested reactive under Sec.  610.40(a)(1) of this
chapter for evidence of infection due to HIV, HBV, or HCV. In addition,
establishments other than Source Plasma establishments must include in
this cumulative record donors deferred from donation under Sec.  610.41
of this chapter because their donation tested reactive under Sec.
610.40(a)(2) of this chapter for evidence of infection due to HTLV or
Chagas disease.
    (3) The cumulative record described in paragraph (e)(2) of this
section must be updated at least monthly to add

donors newly deferred under Sec.  610.41 of this chapter due to
reactive tests for evidence of infection due to HIV, HBV, or HCV, and,
if applicable, HTLV or Chagas disease.
    (4) Establishments must revise the cumulative record described in
paragraph (e)(2) of this section to remove donors who have been
requalified under Sec.  610.41(b) of this chapter.

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
10. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

0
11. Revise the heading for subpart E to read as follows:

Subpart E--Testing Requirements for Relevant Transfusion-
Transmitted Infections

0
12. Add Sec.  610.39 to subpart E to read as follows:

Sec.  610.39  Definitions.

    The definitions set out in Sec.  630.3 of this chapter apply to
this subpart.

0
13. Amend Sec.  610.40 as follows:
0
a. Revise paragraph (a);
0
b. Revise paragraph (b);
0
c. Revise paragraph (c) heading;
0
d. Remove paragraph (c)(2) and redesignate paragraphs (c)(3) and (4) as
paragraphs (c)(2) and (3);
0
e. In redesignated paragraph (c)(2)(i), remove ``communicable disease
agents listed in paragraphs (a)(5) and (a)(6) of this section'' and add
in its place ``relevant transfusion-transmitted infections listed in
Sec.  630.3(h)(iv) of this chapter'';
0
f. In paragraph (d), remove ``communicable disease agents'' and add in
its place ``relevant transfusion-transmitted infections''; and remove
``or by a serological test for syphilis under paragraph (i) of this
section'';
0
g. Revise paragraph (e);
0
h. In paragraph (f), remove ``Health Care Financing Administration''
and add in its place ``Centers for Medicare and Medicaid Services'';
0
i. In paragraph (g) introductory text, remove ``communicable disease
agents'' in both places it appears and add in each place ``relevant
transfusion-transmitted infections''; and remove ``paragraphs (a) and
(i)'' and add in its place ``paragraph (a)'';
0
j. In paragraph (h)(1), remove ``a communicable disease agent(s)
designated in paragraphs (a) and (i)'' in both places it appears and
add in each place ``relevant transfusion-transmitted infection(s)
designated in paragraph (a)'';
0
k. In paragraphs (h)(2)(ii) introductory text, (h)(2)(ii)(C), and
(h)(2)(iv) introductory text, remove ``communicable disease agent(s)''
wherever it appears and add in its place ``relevant transfusion-
transmitted infection(s)'';
0
l. In paragraph (h)(2)(iv)(A), remove ``suitable'' and add in its place
``eligible'';
0
m. In paragraph (h)(2)(vi), remove ``paragraph (i)'' and add in its
place ``paragraph (a)''; and remove ``consistent with Sec.  640.5 of
this chapter,'';
0
n. In paragraph (h)(2)(vii), remove ``Sec.  610.40(i)'' and add in its
place ``Sec.  640.65(a)(2)(ii) and (b)(1)(i)''; and remove ``Sec.
640.65(b)(2)'' and add in its place ``Sec.  640.65(b)(2)(i) through
(b)(2)(iv)''; and
0
o. Remove paragraph (i).
    The revisions read as follows:

Sec.  610.40  Test requirements.

    (a) Human blood and blood components. Except as specified in
paragraphs (c) and (d) of this section, you, an establishment that
collects blood and blood components for transfusion or for use in
manufacturing a product, including donations intended as a component
of, or used to manufacture, a medical device, must comply with the
following requirements:
    (1) Test each donation for evidence of infection due to the
relevant transfusion-transmitted infections described in Sec.
630.3(h)(1)(i) through (iii) of this chapter (HIV, HBV, and HCV).
    (2) Test each donation for evidence of infection due to the
relevant transfusion-transmitted infections described in Sec.
630.3(h)(1)(iv) through (vii) of this chapter (HTLV, syphilis, West
Nile virus, and Chagas disease). The following exceptions apply:
    (i) To identify evidence of infection with syphilis in donors of
Source Plasma, you must test donors for evidence of such infection in
accordance with Sec.  640.65(b) of this chapter, and not under this
section.
    (ii) You are not required to test donations of Source Plasma for
evidence of infection due to the relevant transfusion-transmitted
infections described in Sec.  630.3(h)(1)(iv), (vi), and (vii) of this
chapter (HTLV, West Nile virus, and Chagas disease).
    (iii) For each of the relevant transfusion-transmitted infections
described in Sec.  630.3(h)(1)(iv) through (vii) of this chapter (HTLV,
syphilis, West Nile virus, and Chagas disease):
    (A) If, based on evidence related to the risk of transmission of
that relevant transfusion-transmitted infection, testing each donation
is not necessary to reduce adequately and appropriately the risk of
transmission of such infection by blood or a blood component, you may
adopt an adequate and appropriate alternative testing procedure that
has been found acceptable for this purpose by FDA.
    (B) If, based on evidence related to the risk of transmission of
that relevant transfusion-transmitted infection, testing previously
required for that infection is no longer necessary to reduce adequately
and appropriately the risk of transmission of such infection by blood
or a blood component, you may stop such testing in accordance with
procedures found acceptable for this purpose by FDA.
    (3) For each of the relevant transfusion-transmitted infections
described in Sec.  630.3(h)(1)(viii) through (x) of this chapter (CJD,
vCJD, malaria) and Sec.  630.3(h)(2) of this chapter (other
transfusion-transmitted infections):
    (i) You must test for evidence of infection when the following
conditions are met:
    (A) A test(s) for the relevant transfusion-transmitted infection is
licensed, approved or cleared by FDA for use as a donor screening test
and is available for such use; and
    (B) Testing for the relevant transfusion-transmitted infection is
necessary to reduce adequately and appropriately the risk of
transmission of the relevant transfusion-transmitted infection by
blood, or blood component, or blood derivative product manufactured
from the collected blood or blood component.
    (ii) You must perform this testing on each donation, unless one of
the following exceptions applies:
    (A) Testing of each donation is not necessary to reduce adequately
and appropriately the risk of transmission of such infection by blood,
blood component, or blood derivative product manufactured from the
collected blood or blood component. When evidence related to the risk
of transmission of such infection supports this determination, you may
adopt an adequate and appropriate alternative testing procedure that
has been found acceptable for this purpose by FDA.
    (B) Testing of each donation is not necessary to reduce adequately
and appropriately the risk of transmission of such infection by blood,
blood component, or blood derivative product manufactured from the
collected blood or blood component. When evidence related to the risk
of transmission of

such infection supports this determination, you may stop such testing
in accordance with procedures found acceptable for this purpose by FDA.
    (4) Evidence related to the risk of transmission of a relevant
transfusion-transmitted infection that would support a determination
that testing is not necessary, or that testing of each donation is not
necessary, to reduce adequately and appropriately the risk of
transmission of such infection by blood or blood component, as
described in paragraphs (a)(2)(iii)(A) and (B) of this section, or by
blood, blood component, or blood derivative, as described in paragraphs
(a)(3)(ii)(A) and (B) of this section, includes epidemiological or
other scientific evidence. It may include evidence related to the
seasonality or geographic limitation of risk of transmission of such
infection by blood or blood component, or other information related to
when and how a donation is at risk of transmitting a relevant
transfusion-transmitted infection. It may also include evidence related
to the effectiveness of manufacturing steps (for example, the use of
pathogen reduction technology) that reduce the risk of transmission of
the relevant transfusion-transmitted infection by blood, blood
components, or blood derivatives, as applicable.
    (b) Testing using one or more licensed, approved, or cleared
screening tests. To perform testing for evidence of infection due to
relevant transfusion-transmitted infections as required in paragraph
(a) of this section, you must use screening tests that FDA has
licensed, approved, or cleared for such use, in accordance with the
manufacturer's instructions. You must perform one or more such tests as
necessary to reduce adequately and appropriately the risk of
transmission of relevant transfusion-transmitted infections.
    (c) Exceptions to testing for dedicated donations, medical devices,
and samples. * * *
* * * * *
    (e) Further testing. You must further test each donation, including
autologous donations, found to be reactive by a donor screening test
performed under paragraphs (a) and (b) of this section using a
licensed, approved, or cleared supplemental test, when available. If no
such supplemental test is available, you must perform one or more
licensed, approved, or cleared tests as adequate and appropriate to
provide additional information concerning the reactive donor's
infection status. Except:
    (1) For autologous donations:
    (i) You must further test under this section, at a minimum, the
first reactive donation in each 30 calendar day period; or
    (ii) If you have a record for that donor of a positive result on
further testing performed under this section, you do not have to
further test an autologous donation.
    (2) You are not required to perform further testing of a donation
found to be reactive by a treponemal donor screening test for syphilis.
* * * * *

0
14. Amend Sec.  610.41 as follows:
0
a. In paragraph (a) introductory text, remove ``communicable disease
agent(s) listed in Sec.  610.40(a) or reactive for a serological test
for syphilis under Sec.  610.40(i)'' and add in its place ``relevant
transfusion-transmitted infection(s) under Sec.  610.40(a)'';
0
b. Revise paragraph (a)(1);
0
c. In paragraph (a)(2), remove ``communicable disease agent(s) listed
in'' and add in its place ``relevant transfusion-transmitted
infection(s) under'';
0
d. In paragraphs (a)(3) and (4), remove ``suitable'' and add in its
place ``eligible'';
0
e. In paragraph (a)(5), remove ``communicable disease agent(s)
described under Sec.  610.40(a) or reactive with a serological test for
syphilis under Sec.  610.40(i)'' and add in its place ``relevant
transfusion-transmitted infections(s) under Sec.  610.40(a)''; and
0
f. In paragraph (b), remove ``suitable'' and add in its place
``eligible''.
    The revisions read as follows:

Sec.  610.41  Donor deferral.

    (a) * * *
    (1) You are not required to defer a donor who tests reactive for
anti-HBc or anti-HTLV, types I and II, on only one occasion. However,
you must defer the donor if further testing for HBV or HTLV has been
performed under Sec.  610.40(e) and the donor is found to be positive,
or if a second, licensed, cleared, or approved screening test for HBV
or HTLV has been performed on the same donation under Sec.  610.40(a)
and is reactive, or if the donor tests reactive for anti-HBc or anti-
HTLV, types I and II, on more than one occasion;
* * * * *

Sec.  610.42  [Amended]

0
15. In Sec.  610.42(a), remove ``or reactive for syphilis under Sec.
610.40(i)''; and remove ``communicable disease agent(s)'' and add in
its place ``relevant transfusion-transmitted infection(s)''.

Sec.  610.44  [Amended]

0
16. In paragraph (a)(1) remove ``communicable disease agents listed
in'' and add in its place ``relevant transfusion-transmitted infections
under''; and in paragraph (a)(2) remove ``communicable disease agent''
and add in its place ``relevant transfusion-transmitted infection''.

Sec.  610.46  [Amended]

0
17. Amend Sec.  610.46 as follows:
0
a. In paragraph (a)(2), remove ``a supplemental (additional, more
specific) test'' and add in its place ``further testing'';
0
b. In paragraph (a)(3), remove ``supplemental (additional, more
specific) test results'' and add in its place ``results of further
testing''; and remove ``there is no available supplemental test that is
approved for such use by FDA'' and add in its place ``further testing
under paragraph (a)(2) of this section is not available'';
0
c. In paragraph (a)(4), remove ``supplemental (additional, more
specific) test'' and add in its place ``further testing''; and remove
``there is no available supplemental test that is approved for such use
by FDA'' and add in its place ``further testing is not available''; and
0
d. In paragraph (b)(2), remove ``supplemental (additional, more
specific) test'' and add in its place ``further testing''; and remove
``there is no available supplemental test that is approved for such use
by FDA'' and add in its place ``further testing is not available''; and
0
e. In paragraph (b)(3), remove in the first sentence ``the supplemental
(additional, more specific) test'' and add in its place ``further
testing''; remove in the first sentence ``there is no available
supplemental test that is approved for such use by FDA,'' and add in
its place ``further testing is not available''; remove in the last
sentence ``supplemental (additional, more specific) test results'' and
add in its place ``results of further testing''; and remove in the last
sentence ``there is no available supplemental test that is approved for
such use by FDA'' and add in its place ``further testing is not
available''.

Sec.  610.47  [Amended]

0
18. Amend 610.47 as follows:
0
a. In paragraph (a)(2), remove ``a supplemental (additional, more
specific) test'' and add in its place ``further testing'';
0
b. In paragraph (a)(3), remove in the first sentence ``supplemental
(additional, more specific) test results''

and add in its place ``results of further testing''; and remove in the
first sentence ``there is no available supplemental test that is
approved for such use by FDA'' and add in its place ``further testing
is not available'';
0
c. In paragraph (a)(4), remove ``supplemental (additional, more
specific) test'' and add in its place ``further testing''; and remove
``there is no available supplemental test that is approved for such use
by FDA'' and add in its place ``further testing is not available''; and
0
d. In paragraph (b)(2), remove ``supplemental (additional, more
specific) test'' and add in its place ``further testing''; and remove
``there is no available supplemental test that is approved for such use
by FDA'' and add in its place ``further testing is not available''; and
0
e. In paragraph (b)(3), remove in the first sentence ``supplemental
(additional, more specific) test'' and add in its place ``further
testing''; remove in the first sentence ``there is no available
supplemental test that is approved for such use by FDA'' and add in its
place ``further testing is not available''; remove in the last sentence
``supplemental (additional, more specific) test results'' and add in
its place ``results of further testing''; and remove in the last
sentence ``there is no available supplemental test that is approved for
such use by FDA'' and add in its place ``further testing is not
available''.

PART 630--REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR
TRANSFUSION OR FOR FURTHER MANUFACTURING USE

0
19. The authority citation for part 630 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371; 42
U.S.C. 216, 262, 264.

0
20. Revise the heading for part 630 to read as set forth above.
0
21. Add subpart C with the heading to read as follows:

Subpart C--Donor Notification

0
22. Redesignate Sec.  630.6 as Sec.  630.40, and further redesignate
newly designated Sec.  630.40 to subpart C.
0
23. Amend newly designated Sec.  630.40 as follows:
0
a. Revise the section heading;
0
b. In paragraph (a), revise the first sentence; and remove the word
``supplemental'' from the second and third sentences and add in its
place ``further'';
0
c. In paragraphs (b) introductory text and (b)(1), remove ``suitable''
and add in its place ``eligible'';
0
d. In paragraph (b)(3), remove ``communicable disease agent(s)'' and
add in its place ``relevant transfusion-transmitted infection(s)''; and
remove ``supplemental (i.e., additional, more specific) tests'' and add
in its place ``further testing'';
0
e. In paragraph (c), remove ``suitable'' and add in its place
``eligible'';
0
f. In paragraph (d)(1) introductory text, remove ``communicable disease
agent(s)'' and add in its place ``relevant transfusion-transmitted
infection(s) or whose platelets indicate evidence of a bacterial
infection that is endogenous to the bloodstream of the donor'';
0
g. In paragraph (d)(1)(i), remove ``communicable disease agent(s)'' and
add in its place ``relevant transfusion-transmitted infection(s)''; and
0
h. In paragraph (d)(1)(iii), remove ``communicable disease agent(s)''
and add in its place ``relevant transfusion-transmitted infection(s)'';
and remove ``supplemental (i.e., additional, more specific) tests'' and
add in its place ``further testing'';
    The revisions read as follows:

Sec.  630.40  Requirements for notifying deferred donors.

    (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 relevant
transfusion-transmitted infection(s) as required by Sec.  610.41(a) of
this chapter; any donor who has been deferred as required under Sec.
630.30(b)(3) because their donated platelets have been determined under
Sec.  606.145(d) of this chapter to be contaminated with an organism
that is identified as likely to be associated with a bacterial
infection that is endogenous to the bloodstream of the donor; and any
donor who has been determined not to be eligible as a donor based on
eligibility criteria under Sec. Sec.  630.10 and 630.15. * * *
* * * * *

0
24. Add subparts A and B to part 630 to read as follows:
Subpart A--General Provisions
Sec.
630.1 Purpose and scope.
630.3 Definitions.
Subpart B--Donor Eligibility Requirements
Sec.
630.5 Medical supervision.
630.10 General donor eligibility requirements.
630.15 Donor eligibility requirements specific to Whole Blood, Red
Blood Cells and Plasma collected by apheresis.
630.20 Exceptions for certain ineligible donors.
630.25 Exceptions from certain donor eligibility requirements for
infrequent plasma donors.
630.30 Donation suitability requirements.
630.35 Requalification of previously deferred donors.

Subpart A--General Provisions

Sec.  630.1  Purpose and scope.

    (a) What is the purpose of subparts A, B, and C of this part? The
purpose of these subparts, together with Sec. Sec.  610.40 and 610.41
of this chapter, is to provide certain minimum criteria for each
donation of blood and blood components, for:
    (1) Determining the eligibility of a donor of blood and blood
components;
    (2) Determining the suitability of the donation of blood and blood
components; and
    (3) Notifying a donor who is deferred from donation.
    (b) Who must comply with subparts A, B, and C of this part? Blood
establishments that manufacture blood and blood components, as defined
in Sec.  630.3(a) and (b), must comply with subparts A, B, and C of
this part.

Sec.  630.3  Definitions.

    As used in this part and in part 610, subpart E, and part 640 of
this chapter:
    (a) Blood means a product that is a fluid containing dissolved and
suspended elements which was collected from the vascular system of a
human.
    (b) Blood component means a product containing a part of blood
separated by physical or mechanical means.
    (c) Donor means a person who: (1) Donates blood or blood components
for transfusion or for further manufacturing use; or
    (2) Presents as a potential candidate for such donation.
    (d) Eligibility of a donor means the determination that the donor
is qualified to donate blood and blood components.
    (e) Infrequent plasma donor means a donor who has:
    (1) Not donated plasma by plasmapheresis or a co-collection of
plasma with another blood component in the preceding 4 weeks; and
    (2) Not donated more than 12.0 liters of plasma (14.4 liters of
plasma for donors weighing more than 175 pounds) in the past year.
    (f) Intimate contact with risk for a relevant transfusion-
transmitted infection means having engaged in an

activity that could result in the transfer of potentially infectious
body fluids from one person to another.
    (g) Physician substitute means a trained and qualified person(s)
who is:
    (1) A graduate of an education program for health care workers that
includes clinical training;
    (2) Currently licensed or certified as a health care worker in the
jurisdiction where the collection establishment is located;
    (3) Currently certified in cardiopulmonary resuscitation; and
    (4) Trained and authorized under State law, and/or local law when
applicable, to perform the specified functions under the direction of
the responsible physician.
    (h) Relevant transfusion-transmitted infection means:
    (1) Any of the following transfusion-transmitted infections:
    (i) Human immunodeficiency virus, types 1 and 2 (referred to,
collectively, as HIV);
    (ii) Hepatitis B virus (referred to as HBV);
    (iii) Hepatitis C virus (referred to as HCV);
    (iv) Human T-lymphotropic virus, types I and II (referred to,
collectively, as HTLV);
    (v) Treponema pallidum (referred to as syphilis);
    (vi) West Nile virus;
    (vii) Trypanosoma cruzi (referred to as Chagas disease);
    (viii) Creutzfeldt-Jakob disease (referred to as CJD);
    (ix) Variant Creutzfeldt-Jakob disease (referred to as vCJD); and
    (x) Plasmodium species (referred to as malaria).
    (2) A transfusion-transmitted infection not listed in paragraph
(h)(1) of this section when the following conditions are met:
    (i) Appropriate screening measures for the transfusion-transmitted
infection have been developed and/or an appropriate screening test has
been licensed, approved, or cleared for such use by FDA and is
available; and
    (ii) The disease or disease agent:
    (A) May have sufficient incidence and/or prevalence to affect the
potential donor population; or
    (B) May have been released accidentally or intentionally in a
manner that could place potential donors at risk of infection.
    (i) Responsible physician means an individual who is:
    (1) Licensed to practice medicine in the jurisdiction where the
collection establishment is located;
    (2) Adequately trained and qualified to direct and control
personnel and relevant procedures concerning the determination of donor
eligibility; collection of blood and blood components; the immunization
of a donor; and the return of red blood cells or other blood components
to the donor during collection of blood component(s) by apheresis; and
    (3) Designated by the collection establishment to perform the
activities described in paragraph (i)(2) of this section.
    (j) Suitability of the donation means a determination of whether
the donation is acceptable for transfusion or for further manufacturing
use.
    (k) Trained person means an individual, including a physician
substitute, who is authorized under State law, and/or local law when
applicable, and adequately instructed and qualified to perform the
specified functions under the direction of the responsible physician.
    (l) Transfusion-transmitted infection means a disease or disease
agent:
    (1) That could be fatal or life-threatening, could result in
permanent impairment of a body function or permanent damage to a body
structure, or could necessitate medical or surgical intervention to
preclude permanent impairment of body function or permanent damage to a
body structure; and
    (2) For which there may be a risk of transmission by blood or blood
components, or by a blood derivative product manufactured from blood or
blood components, because the disease or disease agent is potentially
transmissible by that blood, blood component, or blood derivative
product.

Subpart B--Donor Eligibility Requirements

Sec.  630.5  Medical supervision.

    (a) Who must determine the eligibility of a donor? The responsible
physician must determine the eligibility of a donor of blood or blood
components in accordance with this subchapter.
    (b) Which activities related to the collection of blood and blood
components, other than Source Plasma and plasma collected by
plasmapheresis, may the responsible physician delegate?
    (1) The responsible physician may delegate the following activities
to a physician substitute or other trained person:
    (i) Determining the eligibility of a donor and documenting
assessments related to that determination, except the responsible
physician must not delegate:
    (A) The examination and determination of the donor's health
required in Sec.  630.10(f)(2) for donors with blood pressure
measurements outside specified limits, or for certain more frequent
donations under Sec.  630.15(a)(1)(ii);
    (B) The determination of the health of the donor required in
Sec. Sec.  630.10(f)(4), 630.20(a), and 640.21(e)(4) of this chapter.
The responsible physician may make this determination by telephonic or
other offsite consultation; or
    (C) The determination of the health of the donor and the
determination that the blood or blood component collected would present
no undue medical risk to the transfusion recipient, as required in
Sec.  630.20(c). The responsible physician may make these
determinations by telephonic or other offsite consultation.
    (ii) Collecting blood or blood components;
    (iii) Returning red blood cells to the donor during apheresis;
    (iv) Obtaining the informed consent of a plateletpheresis donor as
described in Sec.  640.21(g) of this chapter; or
    (v) Other activities provided that the Director, Center for
Biologics Evaluation and Research, determines that delegating the
activities would present no undue medical risk to the donor or to the
transfusion recipient, and authorizes the delegation of such
activities.
    (2) The responsible physician need not be present at the collection
site when activities delegated under paragraph (b)(1) of this section
are performed, provided that the responsible physician has delegated
oversight of these activities to a trained person who is adequately
trained and experienced in the performance of these activities and is
also adequately trained and experienced in the recognition of and
response to the known adverse responses associated with blood
collection procedures.
    (c) Which activities related to the collection of Source Plasma and
plasma collected by plasmapheresis may the responsible physician
delegate?
    (1) Donor eligibility and blood component collection activities.
(i) The responsible physician may delegate to a physician substitute or
other trained person any of the activities described in paragraph
(c)(1)(i)(A) of this section, provided that the responsible physician
or a physician substitute is on the premises at the collection site:
    (A) The activities listed in paragraphs (b)(1)(i) through (iii) and
(b)(1)(v) of this section, with respect to Source Plasma and plasma
collected by plasmapheresis. However, the responsible physician must
not delegate:

    (1) The examination and determination of the donor's health
required in Sec.  630.10(f)(2) for donors with blood pressure
measurements outside specified limits, or in Sec.  630.15(b)(7) for
certain donors who have experienced red blood cell loss;
    (2) The determination of the health of the donor required in
Sec. Sec.  630.10(f)(4) and 630.20(a) and (b). The responsible
physician may make this determination by telephonic or other offsite
consultation;
    (3) The determination of the health of the donor and the
determination that the blood component would present no undue medical
risk to the transfusion recipient, as required in Sec.  630.20(c). The
responsible physician may make this determination by telephonic or
other offsite consultation.
    (4) The determination related to a donor's false-positive reaction
to a serologic test for syphilis in accordance with Sec.
640.65(b)(2)(iii) of this chapter; and
    (5) The determination to permit plasmapheresis of a donor with a
reactive serological test for syphilis in accordance with Sec.
640.65(b)(2)(iv) of this chapter.
    (B) The collection of Source Plasma in an approved collection
program from a donor who is otherwise determined to be ineligible.
    (C) The collection of a blood sample in accordance with Sec.
640.65(b)(1)(i) of this chapter.
    (ii) The responsible physician, who may or may not be present when
these activities are performed, may delegate to a physician substitute
the following activities:
    (A) Approval and signature for a plasmapheresis procedure as
provided in Sec.  640.65(b)(1)(ii) of this chapter; and
    (B) Review and signature for accumulated laboratory data, the
calculated values of each component, and the collection records in
accordance with Sec.  640.65(b)(2)(i) of this chapter. However, the
responsible physician must not delegate the decision to reinstate the
deferred donor in accordance with that provision.
    (2) Donor immunization. The responsible physician must not delegate
activities performed in accordance with Sec.  640.66 of this chapter,
except that:
    (i) The responsible physician may delegate to a physician
substitute or other trained person the administration of an
immunization other than red blood cells to a donor in an approved
collection program, provided that the responsible physician or a
physician substitute is on the premises at the collection site when the
immunization is administered.
    (ii) The responsible physician may delegate to a physician
substitute the administration of red blood cells to a donor in an
approved collection program, provided that the responsible physician
has approved the procedure and is on the premises at the collection
site when the red blood cells are administered.
    (3) Medical history, physical examination, informed consent, and
examination before immunization. Provided that such activities are
performed under the supervision of the responsible physician, the
responsible physician may delegate to a physician substitute the
activities described in Sec.  630.15(b)(1), (2), and (5). The
responsible physician is not required to be present at the collection
site when the physician substitute performs these activities under
supervision.
    (4) Infrequent plasma donors. (i) For infrequent plasma donors
other than those described in paragraph (c)(4)(ii) of this section, the
responsible physician may delegate to a trained person the activities
listed in paragraphs (b)(1)(i) through (iii) and (b)(1)(v) of this
section and the informed consent requirements described in Sec.
630.15(b)(2). The responsible physician or a physician substitute need
not be present at the collection site when any of these activities are
performed, provided that the responsible physician has delegated
oversight of these activities to a trained person who is not only
adequately trained and experienced in the performance of these
activities but also adequately trained and experienced in the
recognition of and response to the known adverse responses associated
with blood collection procedures. However, the responsible physician
must not delegate:
    (A) The examination and determination of the donor's health
required in Sec.  630.10(f)(2) for donors with blood pressure
measurements outside specified limits, or in Sec.  630.15(b)(7) for
certain donors who have experienced red blood cell loss; or
    (B) The determination of the health of the donor required in Sec.
630.10(f)(4).
    (ii) For infrequent plasma donors who are otherwise ineligible or
are participating in an approved immunization program, the responsible
physician may delegate only in accordance with paragraphs (c)(1)
through (3) of this section.
    (d) Must rapid emergency medical services be available?
Establishments that collect blood or blood components must establish,
maintain, and follow standard operating procedures for obtaining rapid
emergency medical services for donors when medically necessary. In
addition, establishments must assure that an individual (responsible
physician, physician substitute, or trained person) who is currently
certified in cardiopulmonary resuscitation is located on the premises
whenever collections of blood or blood components are performed.

Sec.  630.10  General donor eligibility requirements.

    (a) What factors determine the eligibility of a donor? You, an
establishment that collects blood or blood components, must not collect
blood or blood components before determining that the donor is eligible
to donate or before determining that an exception to this provision
applies. To be eligible, the donor must be in good health and free from
transfusion-transmitted infections as can be determined by the
processes in this subchapter. A donor is not eligible if the donor is
not in good health or if you identify any factor(s) that may cause the
donation to adversely affect:
    (1) The health of the donor; or
    (2) The safety, purity, or potency of the blood or blood component.
    (b) What educational material must you provide to the donor before
determining eligibility? You must provide educational material
concerning relevant transfusion-transmitted infections to donors before
donation when donor education about that relevant transfusion-
transmitted infection, such as HIV, is necessary to assure the safety,
purity, and potency of blood and blood components. The educational
material must include an explanation of the readily identifiable risk
factors closely associated with exposure to the relevant transfusion-
transmitted infection. You must present educational material in an
appropriate form, such as oral, written or multimedia, and in a manner
designed to be understood by the donor. The educational material must
instruct the donor not to donate blood and blood components when a risk
factor is present. When providing educational material to donors under
this section, you may include in those materials the information
required to be provided to donors under paragraph (g)(2)(ii)(E) of this
section.
    (c) When must you determine the eligibility of a donor? You must
determine donor eligibility on the day of donation, and before
collection. Except:
    (1) When a donor is donating blood components that cannot be stored
for more than 24 hours, you may determine the donor's eligibility and
collect a sample for testing required under Sec.  610.40 of this
chapter, no earlier than

2 calendar days before the day of donation, provided that your standard
operating procedures address these activities.
    (2) In the event that, upon review, you find that a donor's
responses to the donor questions before collection were incomplete,
within 24 hours of the time of collection, you may clarify a donor's
response or obtain omitted information required under paragraph (e) of
this section, provided that your standard operating procedures address
these activities.
    (d) How must you determine the eligibility of a donor? You must
determine the donor's eligibility before collection of blood or blood
components, by the following procedures:
    (1) You must consult the records of deferred donors maintained
under Sec.  606.160(e)(1) and (2) of this chapter. Exception: If pre-
collection review of the record described in Sec.  606.160(e)(2) of
this chapter is not feasible because you cannot consult the cumulative
record at the collection site, you must consult the cumulative record
prior to release of any blood or blood component prepared from the
collection.
    (2) Assure that the interval since the donor's last donation is
appropriate;
    (3) Assess the donor's medical history; and
    (4) Perform a physical assessment of the donor.
    (e) How do you assess the donor's medical history? Before
collection you must conduct a medical history interview as described in
this section to determine if the donor is in good health; to identify
risk factors closely associated with exposure to, or clinical evidence
of a relevant transfusion-transmitted infection; and to determine if
there are 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. Your assessment must include each of the following factors:
    (1) Factors that make the donor ineligible to donate because of an
increased risk for, or evidence of, a relevant transfusion-transmitted
infection. A donor is ineligible to donate when information provided by
the donor or other reliable evidence indicates possible exposure to a
relevant transfusion-transmitted infection if that risk of exposure is
still applicable at the time of donation. Information and evidence
indicating possible exposure to a relevant transfusion-transmitted
infection include:
    (i) Behaviors associated with a relevant transfusion-transmitted
infection;
    (ii) Receipt of blood or blood components or other medical
treatments and procedures associated with possible exposure to a
relevant transfusion-transmitted infection;
    (iii) Signs and/or symptoms of a relevant transfusion-transmitted
infection;
    (iv) Institutionalization for 72 hours or more consecutively in the
past 12 months in a correctional institution;
    (v) Intimate contact with risk for a relevant transfusion-
transmitted infection; and
    (vi) Nonsterile percutaneous inoculation.
    (2) Other factors that make the donor ineligible to donate. A donor
is ineligible to donate when donating could adversely affect the health
of the donor, or when the safety, purity, or potency of the blood or
blood component could be affected adversely. Your assessment of the
donor must include each of the following factors:
    (i) Symptoms of a recent or current illness;
    (ii) Certain medical treatments or medications;
    (iii) Travel to, or residence in, an area endemic for a
transfusion-transmitted infection, when such screening is necessary to
assure the safety, purity, and potency of blood and blood components
due to the risks presented by donor travel and the risk of transmission
of that transfusion-transmitted infection by such donors;
    (iv) Exposure or possible exposure to an accidentally or
intentionally released disease or disease agent relating to a
transfusion-transmitted infection, if you know or suspect that such a
release has occurred;
    (v) Pregnancy at the time of, or within 6 weeks prior to, donation;
    (vi) Whether, in the opinion of the interviewer, the donor appears
to be under the influence of any drug, alcohol or for any reason does
not appear to be providing reliable answers to medical history
questions, or if the donor says that the purpose of donating is to
obtain test results for a relevant transfusion-transmitted infection;
and
    (vii) The donor is a xenotransplantation product recipient.
    (f) How do you perform a physical assessment of the donor? You must
determine on the day of donation, and before collection that the donor
is in good health based on the following, at a minimum:
    (1) Temperature. The donor's oral body temperature must not exceed
37.5 [deg]C (99.5[emsp14][deg]F), or the equivalent if measured at
another body site;
    (2) Blood pressure. The donor's systolic blood pressure must not
measure above 180 mm of mercury, or below 90 mm of mercury, and the
diastolic blood pressure must not measure above 100 mm of mercury or
below 50 mms of mercury. A donor with measurements outside these limits
may be permitted to donate only when the responsible physician examines
the donor and determines and documents that the health of the donor
would not be adversely affected by donating.
    (3) Hemoglobin or hematocrit determination. You must determine the
donor's hemoglobin level or hematocrit value by using a sample of blood
obtained by fingerstick, venipuncture, or by a method that provides
equivalent results. Blood obtained from the earlobe is not acceptable.
    (i) Allogeneic donors must have a hemoglobin level or hematocrit
value that is adequate to assure donor safety and product potency. The
following minimum standards apply.
    (A) Female allogeneic donors must have a hemoglobin level that is
equal to or greater than 12.5 grams of hemoglobin per deciliter of
blood, or a hematocrit value that is equal to or greater than 38
percent. Recognizing that lower levels are also within normal limits
for female donors, you may collect blood from female allogeneic donors
who have a hemoglobin level between 12.0 and 12.5 grams per deciliter
of blood, or a hematocrit value between 36 and 38 percent, provided
that you have taken additional steps to assure that this alternative
standard is adequate to ensure that the health of the donor will not be
adversely affected due to the donation, in accordance with a procedure
that has been found acceptable for this purpose by FDA.
    (B) Male allogeneic donors must have a hemoglobin level that is
equal to or greater than 13.0 grams of hemoglobin per deciliter of
blood, or a hematocrit value that is equal to or greater than 39
percent.
    (ii) An autologous donor must have a hemoglobin level no less than
11.0 grams of hemoglobin per deciliter of blood, or a hematocrit value
no less than 33 percent.
    (4) Pulse. The donor's pulse must be regular and between 50 and 100
beats per minute. A donor with an irregular pulse or measurements
outside these limits may be permitted to donate only when the
responsible physician determines and documents that the health of the
donor would not be adversely affected by donating.

    (5) Weight. The donor must weigh a minimum of 50 kilograms (110
pounds).
    (6) Skin examination. (i) The donor's phlebotomy site must be free
of infection, inflammation, and lesions; and
    (ii) The donor's arms and forearms must be free of punctures and
scars indicative of injected drugs of abuse.
    (g) Are there additional requirements for determining the
eligibility of the donor? You must obtain the following from the donor
on the day of donation:
    (1) Proof of identity and postal address. You must obtain proof of
identity of the donor and a postal address where the donor may be
contacted for 8 weeks after donation; and
    (2) Donor's acknowledgement. (i) Prior to each donation, you must
provide information to the donor addressing the elements specified in
paragraphs (g)(2)(ii)(A) through (E) of this section and obtain the
donor's acknowledgement that the donor has reviewed the information.
You must establish procedures in accordance with Sec.  606.100 of this
chapter to assure that the donor has reviewed this material, and
provide for a signature or other documented acknowledgement.
    (ii) The donor acknowledgement must not include any exculpatory
language through which the donor is made to waive or appear to waive
any of the donor's legal rights. It must, at a minimum clearly address
the following:
    (A) The donor has reviewed the educational material provided under
paragraph (b) of this section regarding relevant transfusion-
transmitted infections;
    (B) The donor agrees not to donate if the donation could result in
a potential risk to recipients as described in the educational
material;
    (C) A sample of the donor's blood will be tested for specified
relevant transfusion-transmitted infections;
    (D) If the donation is determined to be not suitable under Sec.
630.30(a) or if the donor is deferred from donation under Sec.  610.41
of this chapter, the donor's record will identify the donor as
ineligible to donate and the donor will be notified under Sec.  630.40
of the basis for the deferral and the period of deferral;
    (E) The donor has been provided and reviewed information regarding
the risks and hazards of the specific donation procedure; and
    (F) The donor has the opportunity to ask questions and withdraw
from the donation procedure.
    (h) What must you do when a donor is not eligible? You must not
collect blood or blood components from a donor found to be ineligible
prior to collection based on criteria in Sec. Sec.  630.10 or 630.15,
or deferred under Sec.  610.41 of this chapter or Sec.  630.30(b)(2),
unless this subchapter provides an exception. You must defer donors
found to be ineligible and you must notify the donor of their deferral
under Sec.  630.40.

Sec.  630.15  Donor eligibility requirements specific to Whole Blood,
Red Blood Cells and Plasma collected by apheresis.

    (a) What additional donor eligibility requirements apply when you,
an establishment that collects blood or blood components, collect Whole
Blood or Red Blood Cells by apheresis?
    (1) Donation frequency must be consistent with protecting the
health of the donor.
    (i) For a collection resulting in a single unit of Whole Blood or
Red Blood Cells collected by apheresis, donation frequency must be no
more than once in 8 weeks, and for apheresis collections resulting in
two units of Red Blood Cells, the donor must not donate more than once
in 16 weeks.
    (ii) The limitations in paragraph (a)(1)(i) of this section apply
unless the responsible physician examines the donor at the time of
donation and one of the following conditions exists:
    (A) The donation is for autologous use as prescribed by the donor's
physician and the responsible physician determines and documents that
the donation may proceed; or
    (B) The donation is a dedicated donation based on the intended
recipient's documented exceptional medical need and the responsible
physician determines and documents that the health of the donor would
not be adversely affected by donating.
    (2) Therapeutic phlebotomy. When a donor who is determined to be
eligible under Sec.  630.10 undergoes a therapeutic phlebotomy under a
prescription to promote the donor's health, you may collect from the
donor more frequently than once in 8 weeks for collections resulting in
a single unit of Whole Blood or Red Blood Cells, or once in 16 weeks
for apheresis collections resulting in two units of Red Blood Cells,
provided that the container label conspicuously states the disease or
condition of the donor that necessitated phlebotomy. However, no
labeling for the disease or condition is required under this section
if:
    (i) The donor meets all eligibility criteria;
    (ii) The donor undergoes a therapeutic phlebotomy as prescribed by
a licensed health care provider treating the donor for:
    (A) Hereditary hemochromatosis; or
    (B) Another disease or condition, when the health of a donor with
that disease or condition will not be adversely affected by donating,
and the donor's disease or condition will not adversely affect the
safety, purity, and potency of the blood and blood components, or any
products manufactured from them, and the collection is in accordance
with a procedure that has been found acceptable for this purpose by
FDA; and
    (iii) You perform without charge therapeutic phlebotomies for all
individuals with that disease or condition.
    (b) What additional donor eligibility requirements apply when you,
an establishment that collects blood or blood components, collect
Source Plasma or plasma by plasmapheresis?
    (1) Medical history and physical examination. Except as provided in
Sec.  630.25:
    (i) The responsible physician must conduct an appropriate medical
history and physical examination of the donor on the day of the first
donation or no more than 1 week before the first donation and at
subsequent intervals of no longer than 1 year.
    (ii) The responsible physician must examine the donor for medical
conditions that would place the donor at risk from plasmapheresis. If
the donor is determined to be at risk, you must defer the donor from
donating.
    (iii) The responsible physician must conduct a new medical history
and physical examination of a donor who does not return for 6 months.
    (2) What requirements apply to obtaining informed consent?
    (i) The responsible physician must obtain the informed consent of a
plasma donor on the first day of donation or no more than 1 week before
the first donation, and at subsequent intervals of no longer than 1
year.
    (ii) The responsible physician must obtain the informed consent of
a plasma donor who does not return within 6 months of the last
donation.
    (iii) The responsible physician must explain the risks and hazards
of the procedure to the donor. The explanation must include the risks
of a hemolytic transfusion reaction if the donor is given the cells of
another donor and the risks involved if the donor is immunized. The
explanation must be made in such a manner that the donor may give their
consent and has a clear opportunity to refuse the procedure.
    (iv) If a donor is enrolled in a new program, such as an
immunization or special collection program, the responsible physician
must again obtain

an informed consent specific for that program.
    (3) Weight. You must weigh a donor at each donation.
    (4) Total protein level. You must determine the donor's total
plasma protein level before each plasmapheresis procedure. The donor
must have a total plasma protein level of no less than 6.0 grams per
deciliter and no more than 9.0 grams per deciliter in a plasma sample
or a serum sample.
    (5) Examination before immunization. (i) No more than 1 week before
the first immunization injection for the production of high-titer
antibody plasma, the responsible physician must conduct an appropriate
medical history and physical examination, as described in paragraph
(b)(1) of this section, in addition to assessing the general donor
eligibility requirements under Sec.  630.10. It is not necessary to
repeat the medical history and physical examination requirement in
paragraph (b)(1) of this section, if the immunized donor's plasma is
collected within 3 weeks of the first immunization injection.
    (ii) You are not required to repeat the medical history and
physical examination required under paragraph (b)(1) of this section
for a donor currently participating in a plasmapheresis collection
program and determined to be eligible under Sec.  630.10 unless the
medical history and physical examination are due under paragraph
(b)(1)(i) or (b)(1)(iii) of this section.
    (6) Deferral of donors due to red blood cell loss. (i) You must
defer a donor from donating plasma by plasmapheresis for 8 weeks if the
donor has donated a unit of Whole Blood, or a single unit of Red Blood
Cells by apheresis. However, you may collect plasma by plasmapheresis
after a donation of Whole Blood or a single unit of Red Blood Cells by
apheresis after at least 2 calendar days have passed, provided that the
extracorporeal volume of the apheresis device is less than 100
milliliters.
    (ii) You must defer a donor from donating plasma by plasmapheresis
for a period of 16 weeks if the donor donates two units of Red Blood
Cells during a single apheresis procedure;
    (iii) You must defer a donor for 8 weeks or more if the cumulative
red blood cell loss in any 8 week period could adversely affect donor
health.
    (7) Exceptions to deferral due to red blood cell loss. You are not
required to defer a Source Plasma donor from donating plasma by
plasmapheresis due to red blood cell loss if the following conditions
are met:
    (i) The responsible physician examines the donor at the time of the
current donation and determines and documents that the donor is in good
health and the donor's health permits the plasmapheresis;
    (ii) The donor's plasma possesses a property, such as an antibody,
antigen, or protein deficiency that is transitory, of a highly unusual
or infrequent specificity, or of an unusually high titer;
    (iii) The special characteristics of the donor's plasma and the
need for plasmapheresis of the donor under Sec.  630.20(b) are
documented at your establishment; and
    (iv) The extracorporeal volume of the apheresis device is less than
100 milliliters.
    (8) Malaria. Freedom from risk of malaria is not required for a
donor of Source Plasma.
    (9) You must comply with other requirements for collection of
plasma in part 640 of this chapter and this part including restrictions
on frequency of collection as specified in Sec. Sec.  640.32 and 640.65
of this chapter.

Sec.  630.20  Exceptions for certain ineligible donors.

    After assessing donor eligibility under Sec. Sec.  630.10 and
630.15, an establishment may collect blood and blood components from a
donor who is determined to be not eligible to donate under any
provision of Sec.  630.10(e) and (f) or Sec.  630.15(a) if one of the
following sets of conditions are met:
    (a) The donation is for autologous use only as prescribed by the
donor's physician, the donor has a hemoglobin level no less than 11.0
grams of hemoglobin per deciliter of blood or a hematocrit value no
less than 33 percent, and the responsible physician determines and
documents that the donor's health permits the collection procedure; or
    (b) The donation is collected under a Source Plasma collection
program which has received prior written approval from the Director,
Center for Biologics Evaluation and Research, to collect plasma for
further manufacturing use into in vitro products for which there are no
alternative sources, the donor meets the criteria in Sec.  630.10(f)(1)
through (6), and the responsible physician determines and documents for
each donation that the donor's health permits the collection procedure,
and the collection takes place under the medical oversight specified in
the approved plasmapheresis program.
    (c) The donation is restricted for use solely by a specific
transfusion recipient based on documented exceptional medical need, and
the responsible physician determines and documents that the donor's
health permits the collection procedure, and that the donation presents
no undue medical risk to the transfusion recipient.

Sec.  630.25  Exceptions from certain donor eligibility requirements
for infrequent plasma donors.

    For an infrequent plasma donor who is not participating in an
immunization program, establishments are not required to:
    (a) Perform a medical history and physical examination of the donor
under Sec.  630.15(b)(1);
    (b) Perform a test for total protein under Sec.  630.15(b)(4);
    (c) Determine the total plasma or serum protein and immunoglobulin
composition under Sec.  640.65(b)(1)(i) of this chapter; or
    (d) Review the data and records as required in Sec.
640.65(b)(2)(i) of this chapter.

Sec.  630.30  Donation suitability requirements.

    (a) When is a donation suitable? A donation is suitable when:
    (1) The donor is not currently deferred from donation as determined
by review of the records of deferred donors required under Sec.
606.160(e) of this chapter;
    (2) The results in accordance with Sec. Sec.  630.10 through 630.25
indicate that the donor is in good health and procedures were followed
to ensure that the donation would not adversely affect the health of
the donor;
    (3) The results in accordance with Sec.  630.10(e) indicate that
the donor is free from risk factors for, or evidence of, relevant
transfusion-transmitted infections and other factors that make the
donor ineligible to donate;
    (4) The donor's blood is tested in accordance with Sec.  610.40 of
this chapter, and is negative or nonreactive, unless an exception
applies under Sec.  610.40(h) of this chapter; and
    (5) The donation meets other requirements in this subchapter.
    (b) What must you do when the donation is not suitable? (1) You
must not release the donation for transfusion or further manufacturing
use unless it is an autologous donation, or an exception is provided in
this chapter.
    (2) You must defer the donor when a donation is determined to be
unsuitable based on the criteria in paragraphs (a)(1) through (4) of
this section.
    (3) You must defer the donor of bacterially contaminated platelets
when the contaminating organism is identified in accordance with Sec.
606.145(d) of this chapter as likely to be associated with a bacterial
infection that is endogenous to the bloodstream of the donor.

    (4) You must notify the deferred donor in accordance with the
notification requirements in Sec.  630.40.

Sec.  630.35  Requalification of previously deferred donors.

    Establishments may determine a deferred donor to be eligible as a
donor of blood and blood components if, at the time of the current
collection, the donor meets the eligibility criteria in this part,
except for the record of the previous deferral, and you determine that
the criteria that were the basis for the previous deferral are no
longer applicable. Criteria for the previous deferral are no longer
applicable if the following conditions are met:
    (a) The previous deferral was for a defined period of time and that
time period has passed, or the deferral was otherwise temporary, such
as a deferral based on eligibility criteria described in Sec. Sec.
630.10(f)(1) through (5) or 630.15(b)(4); or
    (b) For a donor deferred for reasons other than under Sec.
610.41(a) of this chapter, you determine that the donor has met
criteria for requalification by a method or process found acceptable
for such purpose by FDA.

PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

0
25. The authority citation for 21 CFR part 640 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.

Sec.  640.3  [Removed]

0
26. Remove Sec.  640.3.

Sec.  640.4  [Amended]

0
27. In Sec.  640.4, remove and reserve paragraph (a); and in paragraph
(e), remove ``Sec.  640.3'' and add in its place ``Sec.  630.10 of this
chapter''.

Sec.  640.5  [Amended]

0
28. Amend Sec.  640.5 as follows:
0
a. In the introductory text, remove ``at the time of collecting the
unit of blood'';
0
b. Remove and reserve paragraph (a); and
0
c. In heading and text of paragraph (f), remove ``communicable disease
agents'' wherever it appears and add in its place ``relevant
transfusion-transmitted infections''.
0
29. Revise Sec.  640.12 to read as follows:

Sec.  640.12  Eligibility of donor.

    Establishments must determine the eligibility of donors of the
source blood for Red Blood Cells in accordance with Sec. Sec.  630.10
and 630.15 of this chapter.

Sec.  640.14  [Amended]

0
30. In 640.14, remove ``Sec.  640.5(a), (b),'' and add in its place
``Sec.  640.5(b)''.
0
31. Revise Sec.  640.21 to read as follows:

Sec.  640.21  Eligibility of donors.

    (a) Establishments must determine the eligibility of donors of
platelets derived from Whole Blood and donors of platelets collected by
plateletpheresis in accordance with Sec. Sec.  630.10 and 630.15 of
this chapter, except as provided in this section.
    (b) A plateletpheresis donor must not serve as the source of
platelets for transfusion if the donor has recently ingested a drug
that adversely affects platelet function.
    (c) A Whole Blood donor must not serve as the source of platelets
for transfusion if the donor has recently ingested a drug that
adversely affects platelet function unless the unit is labeled to
identify the ingested drug that adversely affects platelet function.
    (d) If you are collecting platelets by plateletpheresis, you must
assess and monitor the donor's platelet count.
    (1) You must take adequate and appropriate steps to assure that the
donor's platelet count is at least 150,000 platelets per microliter (/
[mu]L) before plateletpheresis begins. Exception: If you do not have
records of a donor's platelet count from prior donations and you are
not able to assess the donor's platelet count either prior to or
immediately following the initiation of the collection procedure, you
may collect platelets by plateletpheresis, but you must not collect 9.0
x 10\11\ or more platelets from that donor.
    (2) You must defer from platelet donation a donor whose pre-
donation platelet count is less than 150,000 platelets/[mu]L until a
subsequent pre-donation platelet count indicates that the donor's
platelet count is at least 150,000 platelets/[mu]L; and
    (3) You must take appropriate steps to assure that the donor's
intended post-donation platelet count will be no less than 100,000
platelets/[mu]L.
    (e) Frequency of plateletpheresis collection. (1) The donor may
donate no more than a total of 24 plateletpheresis collections during a
12-month rolling period.
    (2) When you collect fewer than 6 x 10\11\ platelets, you must wait
at least 2 calendar days before any subsequent plateletpheresis
collection. You must not attempt to collect more than 2 collections
within a 7 calendar day period.
    (3) When you collect 6 x 10\11\ or more platelets, you must wait at
least 7 calendar days before any subsequent plateletpheresis
collection.
    (4) Exception. For a period not to exceed 30 calendar days, a donor
may serve as a dedicated plateletpheresis donor for a single recipient,
in accordance with Sec.  610.40(c)(1) of this chapter, as often as is
medically necessary, provided that the donor is in good health, as
determined and documented by the responsible physician, and the donor's
platelet count is at least 150,000 platelets/[mu]L, measured at the
conclusion of the previous donation or before initiating
plateletpheresis for the current donation.
    (f) Deferral of plateletpheresis donors due to red blood cell loss.
(1) You must defer a donor from donating platelets by plateletpheresis
or a co-collection of platelets and plasma by apheresis for 8 weeks if
the donor has donated a unit of Whole Blood, or a single unit of Red
Blood Cells by apheresis unless at least 2 calendar days have passed
and the extracorporeal volume of the apheresis device is less than 100
milliliters.
    (2) You must defer a donor from donating platelets for a period of
16 weeks if the donor donates two units of Red Blood Cells during a
single apheresis procedure.
    (3) You must defer a donor for 8 weeks or more if the cumulative
red blood cell loss in any 8 week period could adversely affect donor
health.
    (g) The responsible physician must obtain the informed consent of a
plateletpheresis donor on the first day of donation, and at subsequent
intervals no longer than 1 year.
    (1) The responsible physician must explain the risks and hazards of
the procedure to the donor; and
    (2) The explanation must be made in such a manner that the donor
may give consent, and has a clear opportunity to refuse the procedure.

0
32. Revise Sec.  640.22(c) to read as follows:

Sec.  640.22  Collection of source material.

* * * * *
    (c) If plateletpheresis is used, the procedure for collection must
be as prescribed in Sec. Sec.  640.21, 640.64 (except paragraph (c)),
and 640.65, or as described in an approved biologics license
application (BLA) or an approved supplement to a BLA.
* * * * *

Sec.  640.23  [Amended]

0
33. In Sec.  640.23(a), remove ``Sec.  640.5(a), (b),'' and add in its
place ``Sec.  640.5(b)''.

Sec.  640.27  [Removed]

0
34. Remove Sec.  640.27.
0
35. Revise Sec.  640.31 to read as follows:

Sec.  640.31  Eligibility of donors.

    (a) Whole Blood donors must meet the criteria for donor eligibility
prescribed in Sec. Sec.  630.10 and 630.15 of this chapter.
    (b) Collection establishments must determine the eligibility of
plasmapheresis donors in accordance with Sec. Sec.  630.10 and 630.15
of this chapter.

Sec.  640.32  [Amended]

0
36. In Sec.  640.32(b), remove ``Sec. Sec.  640.62, 640.64'' and add in
its place ``Sec.  640.64''.

Sec.  640.33  [Amended]

0
37. In Sec.  640.33(a), remove ``Sec.  640.5(a), (b),'' and add in its
place ``Sec.  640.5(b)''.
0
38. Revise Sec.  640.51 to read as follows:

Sec.  640.51  Eligibility of donors.

    (a) Whole blood donors must meet the criteria for eligibility
prescribed in Sec. Sec.  630.10 and 630.15 of this chapter.
    (b) Collection establishments must determine the eligibility of
plasmapheresis donors in accordance with Sec. Sec.  630.10 and 630.15
of this chapter.

Sec.  640.52  [Amended]

0
39. In Sec.  640.52(b), remove ``Sec. Sec.  640.62, 640.64'' and add in
its place ``Sec.  640.64''.

Sec.  640.53  [Amended]

0
40. In Sec.  640.53(a), remove ``Sec.  640.5(a), (b),'' and add in its
place ``Sec.  640.5(b)''.

Sec.  640.61  [Removed]

0
41. Remove Sec.  640.61.

Sec.  640.62  [Removed]

0
42. Remove Sec.  640.62.

Sec.  640.63  [Removed]

0
43. Remove Sec.  640.63.

Sec.  640.64  [Amended]

0
44. In Sec.  640.64, remove and reserve paragraph (a).
0
45. Amend Sec.  640.65 as follows:
0
a. In paragraph (b)(1)(i), revise the first sentence;
0
b. In paragraph (b)(1)(ii), remove ``physician on the premises'' and
add its place ``responsible physician'';
0
c. Revise paragraph (b)(2)(i); and
0
d. In paragraphs (b)(2)(iii) and (iv) remove ``physician on the
premises'' and add in its place ``responsible physician''.
    The revisions read as follows:

Sec.  640.65  Plasmapheresis.

* * * * *
    (b) * * *
    (1)(i) Except as provided under Sec.  630.25 of this chapter, the
responsible physician must draw a sample of blood from each donor on
the day of the initial physical examination or plasmapheresis,
whichever comes first, and at least every 4 months thereafter. * * *
* * * * *
    (2)(i) Except as provided under Sec.  630.25 of this chapter, the
responsible physician must review the accumulated laboratory data,
including any tracings of the plasma or serum protein electrophoresis
pattern, the calculated values of the protein composition of each
component, and the collection records within 14 calendar days after the
sample is drawn to determine whether or not the donor should be
deferred from further donation. If a determination is not made within
14 calendar days, the donor must be deferred pending such a
determination. The responsible physician must sign the review. If the
protein composition is not within normal limits established by the
testing laboratory, or if the total protein level is less than 6.0
grams per deciliter or more than 9.0 grams per deciliter in a plasma
sample or serum sample, the donor must be deferred from donation until
the protein composition returns to acceptable levels. Reinstatement of
the donor into the plasmapheresis program when the donor's protein
composition values have returned to an acceptable level must first be
approved by the responsible physician.
* * * * *

0
46. In Sec.  640.66, revise the first sentence and remove the second
sentence. The revisions read as follows:

Sec.  640.66  Immunization of donors.

    If specific immunization of a donor is to be performed, the
selection, scheduling and administration of the antigen, and the
evaluation of each donor's clinical response, shall be by the
responsible physician. * * *

Sec.  640.67  [Amended]

0
47. In Sec.  640.67, remove ``communicable disease agents'' and add in
its place ``relevant transfusion-transmitted infections''.
0
48. In Sec.  640.69, add paragraphs (e) and (f) to read as follows:

Sec.  640.69  General requirements.

* * * * *
    (e) Restrictions on distribution. Establishments must ensure that
Source Plasma donated by paid donors not be used for further
manufacturing into injectable products until the donor has a record of
being found eligible to donate in accordance with Sec.  630.10 of this
chapter and a record of negative test results on all tests required
under Sec.  610.40(a) of this chapter on two occasions in the past 6
months.
    (f) Hold. Source Plasma donated by paid donors determined to be
suitable for further manufacturing into injectable products must be
held in quarantine for a minimum of 60 calendar days before it is
released for further manufacturing. If, after placing a donation in
quarantine under this section, the donor is subsequently deferred under
Sec.  610.41 of this chapter, or you subsequently determine a donor to
be ineligible under Sec.  630.10 of this chapter due to risk factors
closely associated with exposure to, or clinical evidence of, infection
due to a relevant transfusion-transmitted infection, you must not
distribute quarantined donations from that donor for further
manufacturing use to make an injectable product.

Sec.  640.71  [Amended]

0
49. Amend Sec.  640.71 as follows:
0
a. In paragraph (a) introductory text, remove ``the following tests''
and add in its place ``testing performed in accordance with Sec.
610.40 of this chapter and Sec.  640.65(b)'';
0
b. Remove paragraphs (a)(1) through (4); and
0
c. In paragraph (b)(1), remove ``licensed physician'' and add in its
place ``responsible physician''.
0
50. In Sec.  640.72, revise paragraphs (a)(2) through (4) to read as
follows:

Sec.  640.72  Records.

    (a) * * *
    (2)(i) For each donor, establishments must maintain records
including a separate and complete record of initial and periodic
examinations, tests, laboratory data, and interviews, etc., as required
in Sec. Sec.  630.10 and 630.15 of this chapter and Sec. Sec.  640.65,
640.66, and 640.67, except as provided in paragraph (a)(2)(ii) of this
section.
    (ii) Negative results for testing for evidence of infection due to
relevant transfusion-transmitted infections required in Sec.  610.40 of
this chapter, and the volume or weight of plasma withdrawn from a donor
need not be recorded on the individual donor record if such information
is maintained on the premises of the plasmapheresis center where the
donor's plasma has been collected.
    (3) The original or a clear copy or other durable record which may
be electronic of the donor's consent for participation in the
plasmapheresis program or for immunization.
    (4) Records of the medical history and physical examination of the
donor conducted in accordance with Sec.  630.15(b)(1) of this chapter
and, where applicable, Sec.  630.15(b)(5) of this chapter must document
the eligibility of the donor as a plasmapheresis donor and,

when applicable, as an immunized donor.
* * * * *

0
51. Revise Sec.  640.120 to read as follows:

Sec.  640.120  Alternative procedures.

    (a) The Director, Center for Biologics Evaluation and Research, may
issue an exception or alternative to any requirement in subchapter F of
chapter I of title 21 of the Code of Federal Regulations regarding
blood, blood components, or blood products. The Director may issue such
an exception or alternative in response to:
    (1) A written request from an establishment. Licensed
establishments must submit such requests in accordance with Sec.
601.12 of this chapter;
    (2) An oral request from an establishment, if there are difficult
circumstances and submission of a written request is not feasible.
Establishments must follow up such oral request by submitting written
requests under paragraph (a)(1) of this section within 5 working days.
    (b) To respond to a public health need, the Director may issue a
notice of exception or alternative to any requirement in subchapter F
of chapter I of title 21 of the Code of Federal Regulations regarding
blood, blood components, or blood products, if a variance under this
section is necessary to assure that blood, blood components, or blood
products will be available in a specified location or locations to
address an urgent and immediate need for blood, blood components, or
blood products or to provide for appropriate donor screening and
testing.
    (c) If the Director issues such an exception or alternative orally,
the Director will follow up by issuing a written notice of the
exception or alternative. Periodically, FDA will provide a list of
approved exceptions and alternative procedures on the FDA Center for
Biologics Evaluation and Research Web site.

0
52. Add subpart M, consisting of Sec. Sec.  640.125 and 640.130, to
part 640 to read as follows:

Subpart M--Definitions and Medical Supervision
Sec.
640.125 Definitions.
640.130 Medical supervision.

Sec.  640.125  Definitions.

    The definitions set out in Sec.  630.3 of this chapter apply to the
use of those defined terms in this part.

Sec.  640.130  Medical supervision.

    The requirements for medical supervision established in Sec.  630.5
of this chapter supplement the regulations in this part.

PART 660--ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR
LABORATORY TESTS

0
53. The authority citation for 21 CFR part 660 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.

0
54. Revise Sec.  660.31 to read as follows:

Sec.  660.31  Eligibility of donor.

    Donors of peripheral blood for Reagent Red Blood Cells must meet
all the criteria for donor eligibility under Sec. Sec.  630.10 and
630.15 of this chapter.

PART 820--QUALITY SYSTEM REGULATION

0
55. The authority citation for 21 CFR part 820 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

Sec.  820.1  [Amended]

0
56. In Sec.  820.1(a)(1), remove ``Manufacturers of human blood and
blood components are not subject to this part, but are subject to part
606 of this chapter'' and add in its place ``Manufacturers of blood and
blood components used for transfusion or for further manufacturing are
not subject to this part, but are subject to subchapter F of this
chapter''.

    Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12228 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P