Hospitals, blood collection centers, cord blood banks

ATTACHMENT A

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Blood Action Plan
FDA/CBER is responsible for regulatory oversight of the U.S. blood supply. FDA promulgates and enforces standards for
blood collection and for the manufacturing of blood products, including both transfusible components of whole blood,
pharmaceuticals derived from blood cells or plasma, and related medical devices. FDA also inspects blood establishments
and monitors reports of errors, accidents and adverse clinical events. CBER works closely with other parts of the Public
Health Service (PHS) to establish blood standards, and to identify and respond to potential threats to blood safety or
supply.
CBER initiated a Blood Action Plan in July 1997, to increase the effectiveness of its scientific and regulatory actions, and
to ensure greater coordination with our PHS partners. The Action Plan addresses highly focused areas of concern such as
emergency operations, response to emerging diseases, and updating of regulations. The Department of Health and Human
Services (HHS) accepted this plan in March 1998. The plan is being jointly implemented by CBER, other FDA
components (i.e., Office of Regulatory Affairs, Office of Chief Counsel, and Office of Policy), the Centers for Disease
Control (CDC), the National Institutes of Health (NIH), and the Health Care Financing Administration (HCFA).
Documents published as part of the Blood Action Plan may be obtained at: www.fda.gov/cber/blood/bldpubs.htm.
Updating Blood Regulations
Reinvention of Blood Regulation
Emerging Infectious Diseases
Insuring Compliance of Plasma Fractionation Establishments
Notification and Lookback
FDA Response to Emergencies and Class I Recalls Affecting Blood Safety
Monitoring and Increasing the Blood Supply

ISSUE

Updating Blood Regulations
FDA needs to update obsolete requirements, provide certain product standards, and
convert some guidance into regulation.

PROPOSED
SOLUTION

FDA will be undertaken to completely review, revise and rewrite the blood regulations.

NECESSARY STEPS
a) CBER will create a database of all regulations, guidance and other instructions for
industry;
b) CBER will create a list of needed, but currently non-existent regulations;
c) FDA will prioritize the list;
d) In the priority order each document will be reviewed, revised, up-dated written or
rewritten; and
e) CBER will explore ways of rapidly producing and disseminating new regulation to
industry.

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COMPLETED
TASKS

http://www.fda.gov/cber/blood/bap.htm

a) The database of all existing documents was completed by September, 1997;
b) The list of needed regulations was completed by September, 1997;
c) An initial priority list was developed by October, 1997;
d) The priority list will be reassessed annually to identify emerging needs;
e) FDA has completed the list of highest priority regulations; and
f) FDA published several proposed updates of the blood regulations by October 31, 1999.

PRESENT
INITIATIVES

a) FDA is reviewing the comments to the proposed regulations;
b) FDA is developing several additional regulations to incoporate existing guidance
documents and identified needs; and
c) FDA continues to assess and prioritize needed regulations.

OUTCOME
a) Reduce the number of exemptions to outdated regulations;
b) Reduce the number of guidance documents lacking enforceability through regulations;
and
c) Increase Industry’s compliance with standards.

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ISSUE

Reinvention of Blood Regulation
The current application process is administratively complex and inefficient. There is a need to
develop streamlined application procedures and to increase self-auditing of quality assurance by
industry.

PROPOSED
SOLUTION

NECESSARY
STEPS

Implement a simplified Biologics License Application (BLA) for blood products in lieu of
application review. In addition, develop product and manufacturing standards. Educate the
industry and take effective compliance actions to insure adequate quality assurance and full
compliance with good manufacturing practices by the industry.
a) CBER will develop the information technology infrastructure to support introduction of a
simplified BLA;
b) FDA will identify the manufacturing and product standards for blood products for which
regulatory standards and regulations would be appropriate in lieu of application submissions;
and
c)FDA will develop an industry education and compliance program to support expedited
application review and industry’s full compliance with GMPs.

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COMPLETED
TASKS

http://www.fda.gov/cber/blood/bap.htm

a) The first phase was to implement a simplified BLA. This was completed prior to December
1999. CBER has also written and published guidance for industry on how to use the simplified
BLA for both plasma derivatives and blood components;
b) The second phase was to develop additional manufacturing and product standards in lieu of
detailed application submissions. An inventory of suitable product standards and procedures has
been developed. A proposed pilot program for Gamma Irradiation of Blood and Blood Products
was published January 1998 to determine the feasibility of this approach. The final rule for this
pilot program was published in March 1999.

PRESENT
INITIATIVES

a) A proposed pilot program for Red Blood Cell Immunization is being developed;
b) If these pilot programs are successful other programs which contain suitable standards and
procedures will be added.

OUTCOME
a) More rapid and efficient application review;
b)Decreased number of submissions to FDA; and
c)Improved execution of GMPs and quality assurance by the industry.

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ISSUE

Emerging Infectious Diseases
There are constantly emerging potential threats to the blood supply which require timely action
and a coordinated approach. Examples include new HIV variants; new hepatitis agents; human
herpes virus type 8; Creutzfeld-Jakob Disease; human parvovirus B19; and bacterial
contamination of blood products.

PROPOSED
SOLUTION

NECESSARY
STEPS

A specific scientific and regulatory strategy will be developed for each identified potential
threat. The agency, in collaboration with CDC and NIH, will actively engage in the scientific
investigation of the emerging infectious agents, which would include assessment of the risk to
the blood supply, diagnostic methods, standards development, and regulatory controls.
a) CBER will develop and maintain a database characterizing the effort underway to manage
potential threats to the blood supply;
b) FDA will work closely with NIH and CDC to develop for each recognized emerging agent
strategies that lead to appropriate studies, risk assessment, communication, and any needed
prevention strategies or regulatory controls to protect the blood supply;
c) Proposed prevention strategies or regulatory controls will be brought to public meetings and
Advisory Committees as appropriate to assess implementation proposals; and
d) CBER will meet with PHS agency and other public representatives to discuss current risk
assessment every 6 months.

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COMPLETED
TASKS

http://www.fda.gov/cber/blood/bap.htm

a) A current database of potential threats to the blood supply has been developed and includes
appropriate teams to address each threat;
b) Proposed regulatory actions will be presented as appropriate at the monthly conference call.
c) A chronicle of actions taken by PHS Agencies, since the beginning of the Blood Action Plan,
has been developed.

PRESENT
INITIATIVES

The chronicle of actions taken by PHS Agencies will be reviewed and updated annually.

OUTCOME
a) Improved coordination of FDA efforts with other PHS efforts to address emerging infectious
diseases, and
b) Prevention of transfusion transmitted disease.

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ISSUE

Insuring Compliance of Plasma Fractionation Establishments
The routine inspection of blood and plasma collection establishments has been the responsibility
of ORA for many years. As part of a broader plan to transfer responsibilities for biologic
inspections to the field the responsibility for inspection of plasma fractionators has been
transferred effective November 1996. Additional training in compliance needs to be developed
to enhance the transfer.

PROPOSED
SOLUTION

a) Complete the transfer of the biologics inspection to ORA;
b) Program guidance will be developed and training will be planned and conducted; and
c) A systematic process for reviewing all blood related inspectional findings will be developed
to assure that any industry wide problems are quickly identified and addressed.

NECESSARY
STEPS

a) FDA will complete draft Team Biologics Action Plan;
b) FDA will implement Team Blood as defined in the Team Biologics plan;
c) FDA staff will be trained in the newly defined procedures and develop compliance programs
as needed to implement Team Blood; and
d) The existing transition will require periodic oversight. The Deputy Director, CBER and the
ACRA will meet with appropriate staff until all blood related regulatory activities are in
conformance with ORA standards.

COMPLETED
TASKS

a) The Team Biologics Implementation Plan has been completed;
b) Team Blood has been implemented; and

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c) All Fractionation and Blood Establishments have been inspected by the appropriate cadre of
investigators.
OUTCOME
a) Improve industry compliance with FDA regulations, and
b) Improve agency consistency and efficiency in compliance actions.

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ISSUE

Notification and Lookback
Recipients of blood and plasma products are not routinely notified in a timely manner when
products are recalled. Permanently deferred donors are not routinely notified of the medical
conditions resulting in their deferral. Current look-back requirements address only a narrow
range of conditions.

PROPOSED
SOLUTION

a) FDA will develop regulations and other effective strategies that will clarify the responsibility
of industry to be able to notify product end-users in recall and look-back situations;
b) FDA will re-evaluate the circumstances under which direct patient notification is
appropriate; and
c) CBER will develop regulations to require medical notification of permanently deferred
donors. (Assigned to the updating Blood Regulations Group)

NECESSARY
STEPS

a) Regulations will be written by FDA that require adequate record keeping and an effective
mechanism to identify and notify recipients when a product is implicated in a health hazard;
b) Regulations will be written that require "look-back" for relevant infectious agents. The list of
"relevant" infectious agents will be developed by a team of FDA, NIH, and CDC scientists and
reviewed by the appropriate Advisory Committees; and
c) CBER will develop a regulation for notification of permanently deferred donors. (Assigned
to the Updating Blood Regulations Group)

COMPLETED
TASKS

a) A notice of proposed rulemaking for "recipient notification" was published by FDA August
19, 1999;
b) The list of relevant infectious agents potentially qualifying for "look-back" was developed
by an interagency team and presented to appropriate Advisory Committees. The proposed
regulation was published by FDA on August 19, 1999;
c) FDA has published proposed regulations for the notification of permanently deferred donors
on August 19, 1999. (Assigned to the Updating Blood Regulations Group)

PRESENT
INITIATIVES

Comments to the proposed regulations are being reviewed.

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OUTCOME
a) Donors are notified of their medical deferral leading to opportunities for treatment and
reduced secondary transmission, and
b) Recipients are notified of potential transfusion related risks leading to opportunities for
treatment and reduced secondary transmission.

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FDA Response to Emergencies and Class I Recalls Affecting Blood Safety

ISSUE

FDA needs to use standardized procedures for handling emergencies affecting blood safety.
FDA needs to implement a standardized procedure for managing emergencies related to
blood safety.

PROPOSED
SOLUTION
NECESSARY STEPS

a) Finalize emergency procedures and develop checklists where useful;
b) Train FDA staff;
c) Systematically evaluate FDA’s response to blood emergencies to assure that the process
functioned smoothly and appropriately; and
d) Early decisions on Class I product recalls.
COMPLETED
TASKS

a) Procedures for responses to Emergencies and Class I recalls have been finalized;
b) FDA staff has been educated in the changes made in handling emergency operations;
and
c) A team of senior managers to conduct systematic reviews of blood emergencies has been
selected.

OUTCOME
a) Increase speed, efficiency, and coordination of FDA response to an emergency affecting
blood safety, and
b) Enhanced public health protection in the face of threats to blood safety.

ISSUE

Monitoring and Increasing the Blood Supply
PHS Agencies need to monitor and evaluate the adequacy of the blood supply and take steps to
increase supplies as required.

PROPOSED
SOLUTION
NECESSARY
STEPS

PHS Agencies will establish and oversee data collection mechanisms to permit timely prediction
of blood shortages. PHS Agencies will develop and implement strategies to increase the blood
supply.
a) Monitor the blood supply;

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b) Encourage more donations by eligible donors;
c) Improve donor relations as part of recruitment and retention;
d) Remove restrictions to safe donation; and
e) Address economic issues facing the blood industry.
COMPLETED
TASKS

a) NHLBI has funded a pilot monthly surveillance program for three years starting in November
1999;
b) DHHS is committed to continue to encourage and cooperate with coordinated private sector
initiatives on public service announcements related to blood donor campaigns. Senior health
officials have met with industry to develop a general statement concerning the national blood
supply. DHHS has developed a plan to enlist national philanthropic and other private sector
organizations to take a lead role in promoting blood donations at times of shortage;
c) The first workshop on Donor Incentives was held February 28, 2000;
d) NHLBI has had internal discussions to explore the feasibility of initiating studies on the
development of educational programs to encourage blood donation as a civic responsibility; and
e) The first joint CDC/FDA workshop concerning donor suitability issues was held on June
26-27, 2000.

PRESENT
INITIATIVES

a) A decision will be made within PHS by October 1, 2001 whether to create a long term PHS
Agency responsibility for monitoring the blood supply.
b) FDA will publish guidance on use of Donor Incentives.
c) NHLBI will continue to support evaluation of blood donor incentive models to encourage
donation through workshops and studies to be completed by October 1, 2002.
d) FDA will issue draft guidance to industry on recruitment practices.
e) Based on the results of ongoing NHLBI supported research, FDA will issue guidance on use
of computer assisted interviews.
f) FDA will coordinate a joint government/industry initiative on simplifying and abbreviating the
donor questionnaire to commence by January 1, 2001. A workshop to discuss the donor
questionnaire issues will be held October 16, 2000.
g) FDA will issue guidance on labeling and frequency exemptions for therapeutic
hemochromatosis donations.
h) As funds permit, CDC and FDA have agreed to continue to co-sponsor workshops in FY2000
and FY 2001 to determine the safety and efficacy of policy changes regarding current donor
suitability criteria, test requirements and reentry. Where feasible, FDA will issue guidance to
eliminate unnecessary restrictions.
i) FDA and NHLBI will co-sponsor a workshop with industry to identify and define "best
practices" in donor recruitment on July 6-7, 2000.
j) PHS is committed to bring to discussion at the PHS AC BSA potential safety measures with

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significant cost implications. Funding strategies to address implementation of NAT screening
and leukoreduction are being addressed. DHHS is working to clarify policies on reimbursement
for blood services and products.
OUTCOME
a) Improve the ability to predict and respond to blood shortages; and
b) Increase the availability and elasticity of the blood supply.

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Questions/Comments about the Blood Action Plan, send e-mail to [email protected]
Updated: March 17, 2001

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