Gfi Hiv

Revised Recommendations for
Reducing the Risk of Human
Immunodeficiency Virus Transmission
by Blood and Blood Products
_________________________________________________

Guidance for Industry

Additional copies of this guidance are available from the Office of Communication, Outreach
and Development (OCOD), 10903 New Hampshire Ave., Rm. 3128, Silver Spring, MD 209930002, or by calling 1-800-835-4709 or 240-402-8010, or email [email protected], or from the
Internet at
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm.
For questions on the content of this guidance, contact OCOD at the phone numbers or email
address listed above.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
December 2015

Contains Nonbinding Recommendations

Table of Contents
I.

INTRODUCTION............................................................................................................. 1

II.

BACKGROUND ............................................................................................................... 1
A.
B.
C.
D.
E.
F.
G.

III.

History of Efforts to Reduce HIV Transmission by Blood Products ............... 2
Current Risk of HIV Infection Associated with Specific Behaviors ................ 3
Recent Data Relevant to the Deferral for MSM ................................................ 4
Considerations of the BOTS Working Group .................................................... 7
Outcome of Advisory Committee Meetings ........................................................ 8
Evaluating Alternative Policy Options Using Available Evidence ................... 8
Status of Other Deferral Categories .................................................................. 11

RECOMMENDATIONS................................................................................................ 12
A.
B.
C.
D.
E.
F.
G.

Donor Educational Material and Donor History Questionnaire.................... 12
Donor Deferral .................................................................................................... 14
Donor Requalification ........................................................................................ 16
Product Retrieval and Quarantine; Notification of Consignees of Blood and
Blood Components .............................................................................................. 17
Product Disposition and Labeling ..................................................................... 17
Biological Product Deviation Reporting ........................................................... 20
Testing Requirements and Considerations....................................................... 20

IV.

IMPLEMENTATION .................................................................................................... 21

V.

REFERENCES ................................................................................................................ 22

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Contains Nonbinding Recommendations

Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by
Blood and Blood Products
Guidance for Industry
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.

I.

INTRODUCTION

This guidance document provides you, blood establishments that collect blood or blood
components, including Source Plasma, with FDA’s revised donor deferral recommendations for
individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection.
We (FDA) are also recommending that you make corresponding revisions to your donor
educational materials, donor history questionnaires and accompanying materials, along with
revisions to your donor requalification and product management procedures. This guidance also
incorporates certain other recommendations related to donor educational materials and testing
contained in the memorandum to blood establishments entitled, “Revised Recommendations for
the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood
Products,” dated April 23, 1992 (1992 blood memo) (Ref. 1). This guidance finalizes the draft
guidance of the same title dated May 2015 (80 FR 27973, May 15, 2015) and supersedes the
1992 blood memo. The recommendations contained in this guidance apply to the collection of
blood and blood components, including Source Plasma.
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in FDA’s guidances means that something is suggested or
recommended, but not required.
II.

BACKGROUND

The emergence of Acquired Immune Deficiency Syndrome (AIDS) in the early 1980s and the
recognition that it could be transmitted by blood and blood products had profound effects on the
United States (U.S.) blood system (Refs. 2, 3, 4). Although initially identified in men who have
sex with men (MSM) and associated with male-to-male sexual contact, AIDS was soon noted to
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be transmitted by transfusion of blood products, and by infusion of clotting factor concentrates in
individuals with hemophilia (Refs. 5, 6). Subsequently, AIDS was also found to be associated
with heterosexual transmission through commercial sex work and with intravenous drug use
(Refs. 7, 8). The understanding of risk factors for AIDS in 1983 informed the first blood donor
deferral policy, which at that time was the only way to reduce the chance of transmission of
AIDS through blood product transfusion. In 1984, AIDS was reported to be associated with the
virus now known as HIV, opening the door to development of donor screening tests.
A.

History of Efforts to Reduce HIV Transmission by Blood Products

Beginning in 1983, the FDA issued recommendations for providing donors with
educational material on risk factors for AIDS and for deferring donors with such risk
factors in an effort to prevent transmission of the agent responsible for AIDS (later
understood to be caused by HIV) by blood and blood products (Refs. 2, 9, 10, 11).
Providing donor educational material and asking at-risk donors not to donate was
demonstrated to have a significant impact on preventing HIV transmission prior to the
availability of testing (Ref. 12). However, thousands of recipients of blood and blood
components for transfusion and recipients of plasma-derived clotting factors became
infected with HIV before the causative virus was identified and the first screening tests
for HIV were approved in 1985 (Refs. 2, 4, 10).
Since September 1985, FDA has recommended that blood establishments indefinitely
defer male donors who have had sex with another male, even one time, since 1977, due to
the strong clustering of AIDS illness and the subsequent discovery of high rates of HIV
infection in that population (Ref. 13). On April 23, 1992, FDA issued the 1992 blood
memo, which contains recommendations regarding the deferral for MSM as well as for
other persons with behaviors associated with high rates of HIV exposure, namely
commercial sex workers, those who inject illicit drugs, and certain individuals with other
risk factors.
The use of donor educational material, specific deferral questions, and advances in HIV
donor testing (e.g., HIV antibody assays, p24 antigen assays, and nucleic acid tests
(NAT)) have reduced the risk of HIV transmission from blood transfusion from about 1
in 2500 units prior to HIV testing to a current estimated residual risk of about 1 in 1.47
million transfusions (Refs. 14, 15). The development of pathogen inactivation
procedures for products manufactured from pooled plasma in the 1980s improved the
safety of these products by inactivating lipid-enveloped viruses. No transmissions of
HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) have been documented through
U.S.-licensed plasma-derived products in the past two decades (Ref. 16).
Relating in large part to the development of more sensitive HIV testing methodologies,
there have been calls in the social and scientific literature to revisit the blood donor
deferral policies that were established about three decades ago, in particular, with regard
to the deferral of MSM. During the period from 1997 to 2010, FDA held a number of
public meetings, including workshops and Blood Product Advisory Committee (BPAC)
meetings to further review evidence and to discuss its blood donor deferral policies to
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Contains Nonbinding Recommendations
help prevent the transmission of HIV (Refs. 17, 18, 19, 20). In June 2010, the
Department of Health and Human Services (HHS) brought the issue of deferral of men
who have had sex with another man, even one time, since 1977, for public discussion at a
meeting of the Advisory Committee on Blood Safety and Availability (the Committee).
The Committee heard presentations of currently available scientific data as well as
comments from the public. The Committee recommended to the HHS Secretary “that the
current MSM deferral policy, while suboptimal, should be retained pending the
completion of targeted research studies that might support a safe alternative policy”
(Ref. 21).
Based on these recommendations, in September 2010, an Interagency Blood, Organ &
Tissue Safety Working Group on MSM (BOTS Working Group), consisting of
representatives from the Centers for Disease Control and Prevention (CDC), Health
Resources and Services Administration (HRSA), National Institutes of Health (NIH),
HHS Office of Civil Rights, Office of the Assistant Secretary for Health (OASH), and
FDA, was charged by the Assistant Secretary for Health with exploring the feasibility of
a data and science-driven policy change. Subsequently, the BOTS Working Group
designed and implemented one operational assessment and three research studies to gain
more information to help inform a potential policy change. In addition, it considered the
possibility of conducting a pilot study to assess the effect of a policy change. However,
following review of comments received in response to a Federal Register notice titled,
“Request for Information (RFI) on Design of a Pilot Operational Study To Assess
Alternative Blood Donor Deferral Criteria for Men Who Have Had Sex With Other Men
(MSM)” (77 FR 14801, March 13, 2012) (Ref. 22), requesting comment on potential
pilot study designs, as well as further considerations regarding the significant statistical,
financial and logistical challenges in implementing such a study, the BOTS Working
Group decided that such a pilot study examining the potential effects of a policy change
would not be feasible. Instead, the BOTS Working Group determined that resources at
HHS could be used in more efficient ways to carefully review the studies that had been
initiated (results of which are summarized in section II.C. of this document), to complete
its review of the blood donation deferral criteria, and to establish a national blood safety
monitoring system.
B.

Current Risk of HIV Infection Associated with Specific Behaviors

Recent data indicate that commercial sex work (CSW) and injection drug use (IDU) are
behaviors that continue to place individuals both at a relatively high risk of HIV infection
and at a relatively high risk of window period transmission of HIV (Ref. 23) and few data
are available on the HIV risk in individuals who have discontinued CSW and IDU (Ref.
24). Deferral policies for CSW and IDU are also based on risks for transfusion
transmitted infectious diseases, in addition to HIV, that are associated with these
behaviors (Ref. 25).
Together, these findings continue to support an indefinite deferral of individuals currently
or previously involved in CSW and IDU behaviors pending the availability of additional

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scientific evidence regarding the safety of alternative strategies for evaluating the risk of
these individuals. Therefore, we have not revised the deferral policies for CSW or IDU.
Although MSM represent a small percentage of the U.S. male population (approximately
7% of men report that they have ever participated in MSM activity and approximately 4%
of men report that they engaged in MSM activity in the last 5 years 1) (Ref. 26), they
comprise a large proportion of adults in the United States with existing and newly
diagnosed HIV infections. Among persons living with HIV in 2012, CDC estimates that
56% were MSM (including MSM who were also IDU) (Ref. 27). MSM remain at
increased risk of HIV infection. In 2010, the majority of new HIV infections were
attributed to male-to-male sexual contact: 63% among all adults and 78% among men,
indicating that male-to-male sexual contact remains associated with high risk of HIV
exposure (Ref. 28).
C.

Recent Data Relevant to the Deferral for MSM

The following results became available by mid-2014, from the operational assessment
and all three of the research studies recommended by the BOTS Working Group.
1.

Operational Assessment
The operational assessment examined quarantine release errors. Such
errors occur when a blood establishment accidentally releases a unit of
blood that should not have been released due to issues with donor
qualification or testing. It became clear at an FDA workshop held in
September 2011 that HIV risk from quarantine release errors has been
minimized effectively by increased use of computerized inventory
management, with a remaining small risk of human errors. Following the
workshop, a White Paper was produced by AABB on this topic which
describes a number of measures that could be taken to characterize and
prevent such errors (Ref. 29). Quarantine release errors currently appear
to contribute minimally to the risk of HIV transmission through the blood
supply (Ref. 30).

2.

Donor History Questionnaire Study
The Donor History Questionnaire (DHQ) Study involved cognitive
interviews with potential donors. After receiving donor educational
materials, the potential donors completed the donor history questionnaire,
and were then interviewed regarding their responses (Ref. 31). The key
result of this study, which was highly consistent for both individuals who
only have sex with partners of the opposite sex and MSM, was that
individuals respond to questions posed by the questionnaire as if they were

Purcell et al., have reported that the estimation of the MSM population as a percent of all males over 13 years
differ by recall period: Past 1 year = 2.9%; past 5 years = 3.9%; and ever = 6.9%.

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Contains Nonbinding Recommendations
answering the more general and subjective question in the self-assessed
context of “is my blood safe,” rather than providing an answer to the
literal questions as asked. In addition, the study found that potential
donors might have benefited from shorter donor educational materials and
the ability to answer “I don’t know” to questions that currently accept only
“yes” or “no” responses.
3.

Retrovirus Epidemiology Donor Study-II (REDS-II) TransfusionTransmitted Retrovirus and Hepatitis Virus Rates and Risk Factors Study
The REDS-II Transfusion-Transmitted Retrovirus and Hepatitis Virus
Rates and Risk Factors Study 2011-2013 was a pilot blood donor
surveillance study that evaluated four viral markers (HBV, HCV, human T
cell lymphotrophic virus (HTLV), and HIV) in just over 50% of the
nation’s blood supply (Ref. 32). It also determined behavioral risk factors
that were associated with donations of blood that tested positive for one of
these viruses compared with control donations. In addition to
demonstrating the feasibility of conducting such a surveillance program,
there were several key findings. These included the finding that for each
of these viral infections, the primary behavioral risk factors were
consistent with the known epidemiology for each infection in the United
States and validated the current blood donor deferral criteria. Sex with an
HIV-positive partner and a history of male-to-male sexual contact
remained the two leading independent risk factors for HIV infection in
blood donors as originally observed in CDC-funded studies from the early
1990’s. Sex with an HIV-positive partner was associated with a 132-fold
increase in risk (multivariable adjusted odds ratio) for being HIV-positive,
and a history of male-to-male sexual contact was associated with a 62-fold
increase in risk. By comparison, the increase in risk for a history of
multiple sexual partners of the opposite sex in the last year was 2.3-fold.

4.

Recipient Epidemiology and Donor Evaluation Study-III (REDS-III)
Blood Donation Rules Opinion Study (BloodDROPS)
BloodDROPS examined the opinions of MSM regarding the blood donor
deferral policy through web-based surveys of the MSM community and
non-compliant MSM who donated blood (Ref. 33). A key finding of
particular note was that MSM, who comprise approximately 7% (Ref. 26)
of the U.S. male population, represented an estimated 2.6% of male blood
donors. Although the data were determined by different methodologies,
they suggest an increase in the proportion of blood donors reporting MSM
behavior from 0.6% in 1993 and 1.2% in 1998. The qualitative responses
by both donating and non-donating groups of MSM revealed that these
individuals view the current policy as discriminatory and stigmatizing, and
that some individuals knowingly donate despite the deferral. When asked
about shortening the deferral period, since last male-to-male sexual
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Contains Nonbinding Recommendations
contact, the most common response was that one year was “acceptable as
a compromise,” especially if shorter periods might be considered after
confirming the safety of the new policy. The web-based community
survey revealed that approximately 90% of MSM think the MSM blood
donation deferral should change, and 59% of MSM reported they would
comply with a change to a one-year deferral. In the male blood donor
survey, 83 of 3183 respondents reported donating after male-to-male
sexual contact; 50.6% reported that they would adhere to a one-year
deferral and 18.1% reported “don’t know” (Ref. 33).
The prevalence of HIV infection in male blood donors who reported that
they were MSM was determined to be 0.25%, which is much lower than
the estimated 11-12% HIV prevalence in the population of individuals
reporting regular MSM behavior (Ref. 33). This indicates that
considerable self-selection likely took place in individuals who presented
to donate.
5.

Supportive Data on Australian MSM Policy Change
Some epidemiologic data are available from countries that have changed
their deferral policy for MSM (Refs. 34, 35). The most robust data
measuring the impact of these policy changes are available from Australia
(Ref. 36). Australia also has a voluntary blood donor system and has a
similar percentage of men reporting male-to-male sexual contact at some
time during their lives (5% compared with 7% in the United States (Ref.
26). During the five years before and five years after a change from a
lifetime deferral to a one-year deferral in Australia, there was no change in
risk to the blood supply, defined by the number of HIV positive donations
per year and the proportion of HIV-positive donors with male-to-male sex
as a risk factor. In addition, the compliance rate with the one-year MSM
deferral among male donors in Australia following the policy change was
>99.7% (Ref. 37). Of note, donors in Australia must sign a declaration in
the presence of blood center staff that they understand that there are
penalties, including fines and imprisonment, for providing false or
misleading information. No such declaration is required in the United
States, nor are donors advised of penalties for providing false or
misleading information.
While a number of countries in addition to Australia have adopted a 12
month deferral policy for MSM, at this time, a number of other countries
in Western Europe and the Middle East continue to maintain an indefinite
or permanent deferral policy for MSM. To comply with global regulatory
requirements on deferral policies, manufacturers of blood and blood
components, including Source Plasma, collected in the U.S. and intended
for further manufacturing use in other countries, may not be able to

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implement FDA’s recommended 12 month donor deferral policy for MSM
and instead may maintain longer deferral policies.
D.

Considerations of the BOTS Working Group

Over the course of its deliberations, the BOTS Working Group reviewed and discussed
several different options for the MSM policy:
• no change,
• change to a five-year deferral,
• change to a one-year deferral,
• change to a deferral less than one year,
• pre-testing of potential donors, and
• deferral based upon individual risk assessment.
Although not making a change would maintain the current level of safety of the blood
supply, as noted above, there is evidence that the indefinite deferral policy is becoming
less effective over time. In addition, the indefinite policy is perceived by some as
discriminatory. The data that a five-year deferral would be safer than a one-year deferral
are not compelling. However, some have argued that a five-year deferral would, in
theory, add a safeguard by allowing time for intervention against an emerging infectious
disease that might spread rapidly among MSM and be transmitted through blood
transfusion. Sufficient data are not available to assess the effectiveness of selecting
MSM with low HIV risk based on deferral times of less than one year since last exposure.
The individual risk-based options were not determined to be viable options for a policy
change at this time for a number of reasons: pretesting would be logistically challenging,
and would likely also be viewed as discriminatory by some individuals, and individual
risk assessment by trained medical professionals would be very difficult to validate and
implement in our current blood donor system due to resource constraints. Additionally,
the available epidemiologic data in the published literature do not support the concept
that MSM who report mutual monogamy with a partner or who report routine use of safe
sex practices are at low risk for HIV. Specifically, the rate of partner infidelity in
ostensibly monogamous heterosexual couples and same-sex male couples is estimated to
be about 25%, and condom use is associated with a 1 to 2% failure rate per episode of
anal intercourse (Refs. 38, 39, 40, 41). In addition, the prevalence of HIV infection is
significantly higher in MSM with multiple male partners compared with individuals who
have only multiple opposite sex partners (Ref. 28).
Change to a one-year deferral is also supported by other evidence, including the
experience in countries that have already changed their policies to a one-year deferral
(Argentina, Australia, Brazil, Hungary, Japan, Sweden and United Kingdom). In
addition, this change would potentially better harmonize the deferral for MSM with the
one-year deferral in place for both men and women who engage in certain other sexual
behaviors associated with an increased risk of HIV exposure (e.g., sex with an HIVpositive partner, sex with a commercial sex worker). Thus, following careful review, the
BOTS Working Group was supportive of a policy change to a one-year deferral for
MSM.
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Contains Nonbinding Recommendations
E.

Outcome of Advisory Committee Meetings

Following deliberation of the BOTS Working Group, two advisory committee meetings
were held. The Advisory Committee on Blood and Tissue Safety and Availability
(ACBTSA) met on November 13, 2014, to review the MSM deferral policy (Ref. 33).
The scientific information described in sections II.C. and D. was presented to the
ACBTSA members along with the BOTS Working Group recommendation.
Additionally, the meeting included an open public hearing session. The ACBTSA voted
16 to 2 to recommend a policy change to a one-year MSM deferral. It also recommended
that this change be accompanied by establishment of a robust system to monitor the
safety of the blood supply and a communication plan on the policy change targeted to all
stakeholders.
Subsequently, on December 2, 2014, the BPAC met to consider measurement of HIV
incidence in blood donors as an additional method to assess transfusion risk, and the
potential value of laboratory tests to detect recently acquired HIV infections in
seropositive donors as part of a Transfusion Transmissible Infections Monitoring System
(TTIMS) (Ref. 42). An open public hearing was also held. At that meeting, FDA noted
that it intended to establish in collaboration with the National Heart, Lung, and Blood
Institute (NHLBI), NIH, a general program to monitor the safety of the blood supply for a
number of different transfusion-transmitted viral infections. FDA also noted that it
intended to explore options and engage in public discussions of issues such as
enhancements to education about the donation of safe blood and further evaluation of the
effectiveness of the blood donor history questionnaire. In their comments, some BPAC
committee members indicated support for a change in MSM deferral policy to one year,
and most members noted that they considered concomitant establishment of a blood
donor monitoring program a prerequisite for any policy change. On the topic of testing
for recency of HIV infection, several BPAC committee members commented that tests
looking at how recently HIV infection had been contracted (recency tests 2) could
potentially be very useful additions to the established measures of incidence for
monitoring the safety of the blood supply.
F.

Evaluating Alternative Policy Options Using Available Evidence

FDA is responsible for maintaining the safety of the blood supply in the U.S. FDA
recognizes that the current indefinite deferrals for certain groups are not optimal.
However, changes to the existing deferral policies must be made in the context of
maintaining the high level of safety of the U.S. blood supply achieved to date.
2

HIV recency tests typically involve detailed assessment of the strength and characteristics of antibody profiles that
develop and change over time in response to HIV infection. Thus, it appears to be technically feasible that a
serologically-based HIV recency test, once validated in a blood donor setting, could reflect a high likelihood that an
HIV infection occurred within a certain interval of time (e.g., in the past six months). While such tests are not yet
FDA-approved for this purpose, this additional measure of new HIV infection may increase the statistical power to
assess whether HIV incidence in the blood donor pool changed significantly after a change in the deferral
recommendations.

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Contains Nonbinding Recommendations
The safety of the blood supply rests upon the practical implementation of a combination
of screening measures that are based upon the best available scientific evidence. The
following is a summary of the practical and scientific considerations associated with
various potential options regarding changing the blood donor deferral policy for reducing
the risk of HIV transmission.
1.

No change in policy, continue indefinite deferral. Evidence indicates
that the indefinite deferral policy for men who have had sex with other
men, even once, since 1977 has become less effective over time. Similar
data are not available for CSW and IDU. The rate of non-compliance of
MSM under the indefinite deferral policy appears to be increasing because
the percentage of male donors estimated to be MSM has risen from 0.6%
in 1993, to 1.2% in 1998, and to 2.6% in 2013. Therefore, it is appropriate
to consider alternatives.

2.

Eliminate any deferral related to HIV for all donors and rely on
laboratory testing alone. HIV testing on blood donated in the United
States is currently implemented by assays including nucleic acid testing.
Nucleic acid testing is generally performed on pools of 6 to 16 donor
samples. Pooling of samples both markedly reduces the cost of testing
and is associated with a reduced number of false positive samples. The
window period when recent HIV infection might be missed using this
testing strategy is approximately 9 days. Given this, it has been suggested
that no donor deferral is necessary, given the relatively low likelihood that
a recently infected individual would give blood. However, in the setting
of the approximately 50,000 new HIV infections per year in the United
States, conservative calculations performed by FDA estimate that this
approach could potentially be associated with an approximately four-fold
increase in HIV transmissions resulting from blood transfusions each year.
Such a policy, increasing the potential for the transmission of HIV
infection, is not aligned with maintaining or improving the safety of the
blood supply in the U.S.

3.

Eliminate any deferral related to HIV for all donors and implement
laboratory pre-testing. Rapid tests for HIV infection have been
approved, and could potentially be used at blood collection centers to prescreen potential donors in order to reduce collection of HIV-positive units.
However, such tests do not address the problem of identifying recently
infected donors. Testing individuals 10 to 14 days in advance of blood
donation and then retesting them on the day of donation could
theoretically reduce the potential for window period transmission of HIV
without the need for a prolonged period of sexual abstinence, so long as
individuals refrain from sexual activity between the time that the initial
testing is performed and the time of blood donation, when such testing
would be performed again. However, retesting donors for the millions of
donations made each year would add significant burden to donors to
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Contains Nonbinding Recommendations
appear for donation on two separate occasions and would add very
significant logistic complexity to the blood donor system. For example,
initial testing would need to be completed and the results would need to be
available for review at the time individuals returned to donate during the
specific time interval during which the results would be valid. An
alternative, pre-testing those individuals identified through certain
screening questions as potentially being at increased risk of HIV, would
first require validation of the questions posed and would have similar
logistic complexity.
4.

Individually assess donor risk. Although individual donor assessment
for risk of HIV and other infections has been implemented in a few
countries, significant differences exist regarding the situation in those
countries and the situation in the United States. For example, in South
Africa, HIV transmission is primarily heterosexual and every unit is
screened individually for HIV, given the epidemiology affecting all
available blood donors. Individual risk assessment presents significant
challenges in the United States for a number of reasons. At this time there
are inadequate data to support the effectiveness of the use of donor
educational materials and questionnaires on safe sexual practices for the
prevention of transfusion-transmitted infections through donated blood. In
addition, self-report of monogamy cannot be relied upon because of the
relatively high rate of infidelity between partners in any type of sexual
relationship (Ref. 38). Even if a potential donor is truthful in providing
responses regarding his or her own behavior, the response may not be
meaningful if a partner has not been monogamous. Although the
effectiveness of individual assessment of donor risk can be explored in the
future, currently there is no validated and accepted individual risk
assessment tool or questionnaire.

5.

Implement a time-based deferral. Although it might seem that any
deferral longer than the 9 day window period would be effective, this
assumption is incorrect because of recall bias, non-compliance, and other
behavioral factors. As a group, in the United States, MSM have the
highest HIV risk: according to CDC, two-thirds of new HIV infections
occur in the approximately 2% of the population who are MSM (Ref. 27).
The risk of HIV among MSM is more than twenty-fold higher than that of
men who have sex with multiple female partners and women who have
sex with multiple male partners (Ref. 32). Thus, absent another
scientifically-validated way of identifying individuals at highest risk of
transmitting HIV, a time-based deferral for MSM since last sexual
encounter is the one deferral policy that has been demonstrated to be
effective in a setting with similar HIV epidemiology to the United States.
The data available from the transition to a one-year deferral policy in
Australia are particularly compelling because it monitored the effect of the
change using a national blood surveillance program. Data for the five
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years preceding and following the change from an indefinite to a one-year
deferral showed no detectable decrease in safety of the blood supply.
Twenty-four HIV-positive donations were identified among 4,025,571
donations prior to the change in policy compared with 24 among
4,964,628 donations following it. Scientifically robust data are not
available for time-based deferral periods of less than one year.
FDA concludes that the available evidence most strongly supports a change from the
indefinite deferral to a one year blood donor deferral policy for MSM, and FDA expects
that this change will maintain or improve blood safety with respect to HIV. FDA will
continue to monitor the safety of the blood supply, including the effect of a change to a
one year deferral.
G.

Status of Other Deferral Categories

In addition to the behavioral deferrals noted for MSM, CSW and IDU, the 1992 blood
memo addressed several other deferrals that had been recommended in order to reduce
the risk of HIV transmission through the blood supply (Ref. 1). For most of these
deferrals, directly applicable data are not available at this time to support a change in the
existing deferral policies.
In the case of the deferral for persons with hemophilia or related clotting disorders who
have received clotting factor concentrates, the rationale for deferral has changed from
prevention of HIV transmission to that of ensuring that donors are not harmed by the use
of large bore needles used during the donation process. Given the enhanced safety
measures now used in the manufacture of clotting factor concentrates (Ref. 16), FDA
does not consider the receipt of FDA-licensed clotting factor concentrates or sex with a
person that has received clotting factor concentrates to be a risk factor for HIV or
hepatitis. Therefore, we no longer recommend deferral for individuals who have had sex
with an individual with hemophilia or related clotting factor deficiencies who has used
clotting factor concentrates. Further, FDA has not recommended a deferral for the
receipt of other FDA-licensed plasma-derivatives because of HIV or hepatitis risk 3.
H.

Blood Safety Monitoring

A Transfusion Transmissible Infections Monitoring System (TTIMS) is being
implemented in the United States in order to facilitate monitoring of the safety of the U.S.
blood supply for a variety of different pathogens. FDA will use TTIMS to further
investigate and refine blood safety screening measures over the coming years. Through
this monitoring system a variety of donor risk factors can also be evaluated, based in part
upon further investigation of units donated that are detected upon screening to contain
infectious agents. Based upon the information obtained from TTIMS and other sources,
3

Consistent with the donor history questionnaires and accompanying materials prepared by AABB and Plasma
Protein Therapeutics Association (PPTA) and found acceptable by FDA, a voluntary donor deferral exists for the
receipt of Hepatitis B Immune Globulin because the donor had been recently exposed to hepatitis B virus.

11

Contains Nonbinding Recommendations
additional studies may be undertaken in the future in order to further assess the
effectiveness of alternatives to time-based donor deferral strategies, including such
approaches as individual risk assessments. As part of its ongoing efforts to ensure the
safety of the blood supply, FDA intends to routinely review information from the TTIMS
along with emerging scientific evidence to reevaluate its donor deferral policies.
III.

RECOMMENDATIONS

The following sections summarize the revised recommendations related to blood donor deferral
and requalification related to reducing the risk of HIV transmission by blood and blood products.
Given the passage of time, and in order to simplify practical application of these criteria for
donors and blood collection establishments, reference made previously in some criteria to “since
1977” has been dropped as the period of time during which individuals are assessed to be at risk
of transmitting HIV.
A.

4

Donor Educational Material and Donor History Questionnaire
1.

We recommend that donors be provided donor educational material before
each donation explaining the risk of HIV transmission by blood and blood
products and certain behaviors associated with the risk of HIV infection so
that donors can self defer. We recommend the donor educational
materials explain that individuals with risk factors for HIV need to be
aware of the signs and symptoms associated with acute HIV infection,
namely fever, enlarged lymph nodes, sore throat and rash. 4 FDA currently
recommends, and under 21 CFR 630.10(b), effective May 23, 2016, FDA
will require that donor educational material be presented to donors in a
manner they will understand, which may include oral, written, or
multimedia formats, and must instruct the donor not to donate when a risk
factor for HIV infection is present. The donor educational material should
indicate that individuals who have engaged in any activity or who have
any risk factor that would result in a deferral (see section III.B. of this
guidance) should not donate blood or blood components.

2.

We recommend that blood collection establishments update their donor
educational material, DHQ, including full-length and abbreviated DHQs,
and accompanying materials (e.g., flow charts) and processes to
incorporate the recommendations provided in this guidance.

See CDC website at http://www.cdc.gov/hiv/basics/whatishiv.html.

12

Contains Nonbinding Recommendations
3.

We recommend that the updated DHQ include the following elements to
assess donors for risk:
a.
b.
c.
d.

e.
f.

g.
h.
i.
j.

A history ever of a positive 5 test for HIV,
A history ever of exchanging sex 6 for money or drugs,
A history ever of non-prescription injection drug use 7,
A history in the past 12 months of sex with any of the following
individuals: a person with a history ever of positive test for HIV, a
person with a history ever of exchanging sex for money or drugs,
or a person with a history ever of non-prescription injection drug
use,
A history in the past 12 months of receiving a transfusion of Whole
Blood or blood components such as packed red blood cells,
platelets, or plasma,
A history in the past 12 months of contact with blood of another
individual through percutaneous inoculation such as a needle stick
or through contact with a donor’s open wound or mucous
membranes,
A history in the past 12 months of a tattoo, ear or body piercing,
A history in the past 12 months of syphilis or gonorrhea, or
treatment for syphilis or gonorrhea,
For male donors: a history in the past 12 months of sex with
another man,
For female donors: a history in the past 12 months of sex with a
man who has had sex with another man in the past 12 months.

Note: In the context of the donor history questionnaire, FDA recommends that
male or female gender be taken to be self-identified and self-reported.

5

In this context, “positive” includes reactive test results on an HIV diagnostic assay and repeatedly reactive or
reactive results on antibody or NAT blood donor screening assays, respectively.
6
Throughout this guidance the term “sex” refers to having anal, oral, or vaginal sex, regardless of whether or not a
condom or other protection is used.
7
Non-prescription injection drug use includes not only the injection of non-prescription drugs, but also includes the
improper injection of legally-prescribed drugs, such as injecting a prescription drug intended for oral administration
or injecting a prescription drug that was prescribed for another individual.

13

Contains Nonbinding Recommendations
B.

Donor Deferral

We recommend that you defer as follows:
1.

Defer indefinitely an individual who has ever had a positive test for HIV 8.

2.

Defer indefinitely an individual who has ever exchanged sex for money or
drugs.

3.

Defer indefinitely an individual who has ever engaged in non-prescription
injection drug use.

4.

Defer for 12 months from the most recent sexual contact any individual
who has a history of sex with a person who: has ever had a positive test
for HIV, ever exchanged sex for money or drugs, or ever engaged in nonprescription injection drug use.

5.

Defer for 12 months from the most recent allogeneic transfusion any
individual who has a history of receiving an allogeneic transfusion of
Whole Blood or blood components.

6.

Defer for 12 months from the most recent exposure, any individual who
has a history of contact with blood of another individual through
percutaneous inoculation such as a needle stick or through contact with a
donor’s open wound or mucous membranes.

7.

Defer for 12 months from the most recent tattoo, ear or body piercing, an
individual who has a history of tattoo, ear or body piercing. However,
individuals who have undergone tattooing within 12 months of donation
are eligible to donate if the tattoo was applied by a state regulated entity
with sterile needles and non-reused ink. Individuals who have undergone
ear or body piercing within 12 months of donation are eligible to donate if
the piercing was done using single-use equipment.

8.

Defer for 12 months after completion of treatment, an individual with a
history of syphilis or gonorrhea, or an individual with a history of
diagnosis or treatment for syphilis or gonorrhea in the past 12 months.

9.

Defer for 12 months from the most recent sexual contact, a man who has
had sex with another man during the past 12 months.

8

A donor deferred because of a repeatedly reactive or reactive result on an antibody or a NAT blood donor
screening assay, respectively, may be considered for re-entry by a requalification method or process found
acceptable for such purposes by FDA (21 CFR 610.41(b)). Current FDA recommendations are found in “Guidance
for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C
Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry, dated May 2010. Under 21 CFR
630.35(b), effective May 23, 2016, deferred donors with a previously false-positive result on an HIV diagnostic test
may be considered for re-entry by a requalification method or process found acceptable for such purposes by FDA
(21 CFR 630.35(b)). We recommend that you contact FDA for recommendations on a case by case basis for an
acceptable requalification method or process.

14

Contains Nonbinding Recommendations
10.

Defer for 12 months from the most recent sexual contact, a female who
has had sex during the past 12 months with a man who has had sex with
another man in the past 12 months.

We recommend that you defer indefinitely an individual with hemophilia or related
clotting factor deficiencies requiring treatment with clotting factor concentrates for
reasons of donor safety, rather than based upon the risk of HIV infection. Accordingly,
we no longer recommend deferral for individuals who have had sex with an individual
with hemophilia or related clotting factor deficiencies requiring treatment with clotting
factor concentrates.
Notes:
1.

Additional recommendations for donor deferral to reduce the risk of HIV
transmission by blood and blood products have been established in other
FDA guidance documents, including:
•

“Guidance for Industry: Recommendations for Screening, Testing,
and Management of Blood Donors and Blood and Blood
Components Based on Screening Tests for Syphilis,” dated
September 2014;

•

“Guidance for Industry - Recommendations for Management of
Donors at Increased Risk for Human Immunodeficiency Virus
Type 1 (HIV-1) Group O Infection,” dated August 2009; and,

•

“Memorandum to All Registered Blood Establishments Recommendations for the Deferral of Current and Recent Inmates
of Correctional Institutions as Donors of Whole Blood, Blood
Components, Source Leukocytes, and Source Plasma,” dated June
8, 1995.

2.

Collections from donors at risk of HIV infection must be approved by
CBER under 21 CFR 640.120, consistent with the “Guideline for
Collection of Blood or Blood Products from Donors with Positive Tests
for Infectious Disease Markers (“High Risk” Donors),” dated September
1989.

3.

FDA currently recommends, and under 21 CFR 630.5 and 630.10(a),
effective May 23, 2016, FDA will require the responsible physician of a
blood collection establishment to determine the eligibility of a donor, and

15

Contains Nonbinding Recommendations
to defer any donor if the donation could adversely affect the health of the
donor or the safety of the blood or blood component. 9
C.

Donor Requalification
1.

Donors deferred because of a history of sex during the past 12 months
with any of the following individuals: a person who has a positive test for
HIV; a person with a history of exchanging sex for money or drugs; or a
person with a history of non-prescription injection drug use, may be
eligible to donate provided that 12 months since the last sexual contact
have passed and they meet all other donor eligibility criteria.

2.

Donors deferred because of a history of receiving an allogeneic
transfusion of Whole Blood or blood components such as packed red
blood cells, platelets, or plasma during the past 12 months may be eligible
to donate if 12 months have passed since their last allogeneic transfusion
and they meet all other donor eligibility criteria.

3.

Donors deferred because of a history of contact with blood of another
individual through percutaneous inoculation such as a needle stick or
through contact with a donor’s open wound or mucous membranes during
the past 12 months may be eligible to donate if 12 months have passed
since their last exposure and they meet all other donor eligibility criteria.

4.

Donors deferred because of a history of tattoo, ear or body piercing in the
past 12 months may be eligible to donate if 12 months have passed since
their last tattoo, ear or body piercing and they meet all other donor
eligibility criteria.

5.

Donors deferred because of a history of syphilis or gonorrhea, or treatment
for syphilis or gonorrhea in the past 12 months may be eligible to donate if
12 months have passed since diagnosis and completion of treatment and
they meet all other donor eligibility criteria.

6.

Male donors previously deferred because of a history of sex with another
man, even one time, since 1977, may be eligible to donate provided that
they have not had sex with another man during the past 12 months and
they meet all other donor eligibility criteria.

7.

Male donors deferred because of a history of sex with another man in the
past 12 months may be eligible to donate provided they have not had sex

9

See “Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use”
final rule (80 FR 29842, May 22, 2015) https://www.federalregister.gov/articles/2015/05/22/201512228/requirements-for-blood-and-blood-components-intended-for-transfusion-or-for-further-manufacturing. The
final rule is effective May 23, 2016.

16

Contains Nonbinding Recommendations
with another man during the past 12 months and they meet all other donor
eligibility criteria.
8.

D.

Female donors deferred because of a history of sex in the past 12 months
with a man who has had sex with another man in the past 12 months may
be eligible to donate provided that during the past 12 months the female
donors have not had sex with a man who has had sex with another man in
the past 12 months and the female donors meet all other donor eligibility
criteria.

Product Retrieval and Quarantine; Notification of Consignees of Blood and
Blood Components

If you collected blood or blood components from a donor who tests reactive for HIV on
that donation, or when you are made aware of other reliable test results or information
indicating evidence of HIV infection, you must follow the HIV “lookback” requirements
in 21 CFR 610.46.
In addition, we recommend that you take the following actions if you determine that
blood or blood components have been collected from a donor who should have been
deferred according to the recommendations in section III.B. 2-10 of this guidance, for
reasons other than a positive HIV test result.

E.

1.

If you collected blood or blood components from a donor who should have
been deferred according to the recommendations in section III.B. of this
guidance, we recommend that you quarantine and destroy any
undistributed in-date blood or blood components collected from that
donor.

2.

If you distributed blood or blood components collected from a donor who
should have been deferred according to the recommendations in section
III.B. of this guidance, we recommend that you notify consignees of the
in-date blood and blood components collected from the donor during the
period that he or she should have been deferred. We recommend that the
consignee retrieve and quarantine the in-date blood and blood components
collected from that donor during the period he or she should have been
deferred. We do not recommend retrieval and quarantine of plasma
pooled for further manufacturing into products that are manufactured
under processes that include validated viral clearance steps, which have
been shown to be robust in the clearance of lipid-enveloped viruses.

Product Disposition and Labeling
1.

We recommend that you destroy or re-label blood or blood components
that were collected from a donor who should have been deferred based on
risk factors for HIV infection in accordance with the recommendations in
17

Contains Nonbinding Recommendations
section III.B. of this guidance. If you re-label the blood or blood
components as described in this section, they may be released for research
or for manufacture into noninjectable products or in vitro diagnostic
reagents when no other suitable sources are available.
a.

You must use the following statement to prominently re-label the
blood or blood components originally collected for transfusion in
accordance with 21 CFR 606.121(f):
“NOT FOR TRANSFUSION: Collected From a Donor
Determined To Be At Risk For Infection With HIV”
In addition, you should include one of the following cautionary
label statements, as applicable:
“Caution: For Laboratory Research Only”
or
“Caution: For Further Manufacturing into In Vitro Diagnostic
Reagents For Which There Are No Alternative Sources”
or
“Caution: For Use in Manufacturing Noninjectable Products
Only”
And, for recovered plasma:
“Not for Use in Products Subject to License Under Section 351 of
the Public Health Service Act”

b.

You should use the following statements to prominently re-label
the un-pooled blood or blood components originally collected or
intended for further manufacture:
“Collected from a Donor Determined to be at Risk for Infection
with HIV”
And
“Caution: For Laboratory Research Only”
or
“Caution: For Further Manufacturing into In Vitro Diagnostic
Reagents For Which There Are No Alternative Sources”
18

Contains Nonbinding Recommendations
or
“Caution: For Use in Manufacturing Noninjectable Products
Only”
And, for recovered plasma:
“Not for Use in Products Subject to License Under Section 351 of
the Public Health Service Act”
2.

You must destroy or re-label blood or blood components, including
Source Plasma, collected from a donor who currently tests reactive for
HIV or collected from a donor deferred for reactive HIV testing
(21 CFR 610.40(h)). If you re-label the blood or blood components,
including Source Plasma, in accordance with 21 CFR 610.40(h) and
606.121, the blood or blood components may be released for research or
for manufacture into noninjectable products or in vitro diagnostic reagents
when no other suitable sources are available. You must label the reactive
unit with the “BIOHAZARD” legend (21 CFR 610.40(h)(2)(ii)(B)), and:
a.

You must use the following statement to prominently re-label the
blood or blood components originally collected for transfusion
(21 CFR 606.121(f)):
“NOT FOR TRANSFUSION: Collected From a Donor
Determined To Be Reactive for HIV”
In addition, you should use one of the following cautionary label
statements, as applicable:
“Caution: For Laboratory Research Only”
or
“Caution: For Further Manufacturing into In Vitro Diagnostic
Reagents For Which There Are No Alternative Sources”
or
“Caution: For Further Manufacturing Use as a Component of a
Medical Device For Which There Are No Alternative Sources”

b.

You must use the following statement to prominently re-label the
un-pooled blood or blood components, including Source Plasma,
originally collected or intended for further manufacture
(21 CFR 610.40(h)(2)(ii)(C)):
19

Contains Nonbinding Recommendations

“Collected from a Donor Determined to be Reactive for Infection
with HIV”
In addition, you should use one of the following cautionary label
statements, as applicable:
“Caution: For Laboratory Research Only”
or
“Caution: For Further Manufacturing into In Vitro Diagnostic
Reagents For Which There Are No Alternative Sources”
or
“Caution: For Further Manufacturing Use as a Component of a
Medical Device For Which There Are No Alternative Sources”
F.

Biological Product Deviation Reporting

If you have distributed blood or blood components for transfusion or for further
manufacturing, collected from a donor who should have been deferred according to
section III.B. of this guidance, you should report a biological product deviation as soon as
possible, but you must report within 45 calendar days from the date you acquire the
information reasonably suggesting that a reportable event has occurred
(21 CFR 606.171).
G.

Testing Requirements and Considerations

Section 610.40(a) (21 CFR 610.40(a)) requires establishments that collect blood or blood
components to test each donation intended for use in preparing a product, for evidence of
infection due to HIV type 1 (HIV-1) and HIV type 2 (HIV-2). In addition,
21 CFR 610.40(b) requires you to use one or more approved screening test as necessary
to reduce adequately and appropriately the risk of transmission of HIV-1 and HIV-2.
FDA has considered the use of approved donor screening tests for antibodies to both
HIV-1 and HIV-2 as necessary to reduce adequately and appropriately the risk of
transmission of HIV. In addition, FDA recommendations on the use of approved HIV-1
nucleic acid donor screening tests to meet the requirements under 21 CFR 610.40(b) are
found in, “Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual
Samples from Donors of Whole Blood and Blood Components (including Source Plasma
and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of
Transmission of HIV-1 and HCV,” dated October 2004.
You must defer a donor who tests reactive by a donor-screening test for HIV-1 or HIV-2
(21 CFR 610.41), you must perform further testing using a supplemental test on
20

Contains Nonbinding Recommendations
donations that test reactive on a screening test, when available. If no supplemental test is
available, you must perform one or more licensed, approved or cleared test as adequate
and appropriate to provide additional information regarding the donor’s infection status.
(21 CFR 610.40(e)). You must make reasonable attempts to notify a donor who has been
deferred based on the results of tests for communicable diseases (21 CFR 630.6). Where
appropriate, donors who are deferred because of reactive test results should be provided
information about the need for medical follow-up and counseling.
Current FDA recommendations are found in “Guidance for Industry: Nucleic Acid
Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C
Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry,” dated
May 2010. In addition, for the purpose of donor counseling, if a donation tests repeatedly
reactive for antibodies to HIV-1/HIV-2 or for HIV-2 on an approved donor screening
test, but HIV-1 positivity is not confirmed on an approved supplemental test, further
testing may be performed using licensed or approved tests to diagnose HIV-2 infection
and clarify the donor’s infection status.
IV.

IMPLEMENTATION

You may implement these recommendations once you have revised your donor educational
material, DHQ, including full-length and abbreviated DHQs, and accompanying materials to
reflect the new donor deferral recommendations. Licensed blood establishments must report the
indicated revisions to FDA in the following manner (21 CFR 601.12):
1. Revision of your own donor educational materials, DHQ and accompanying
materials must be submitted to FDA as a prior approval supplement (PAS) under
21 CFR 601.12(b).
2. Revision of a previously FDA accepted DHQ and accompanying materials must
be reported as a major change if you are revising the FDA accepted DHQ and
accompanying materials to implement these new recommendations. Report such
a change to FDA as a prior approval supplement (PAS) under 21 CFR 601.12(b).
3. If the current version of the donor educational materials, DHQ and accompanying
materials prepared by the AABB Donor History Task Force or PPTA are revised
to contain the recommendations in this guidance and are found acceptable by
FDA, we would consider the implementation of the donor educational materials,
DHQ and accompanying materials to be minor changes, if implemented without
modification and in their entirety as a complete process for administering
questions to donors. Report such a change to FDA in your annual report under
21 CFR 601.12(d), noting the date the process was implemented.

21

Contains Nonbinding Recommendations
V.

REFERENCES

1.

FDA Memorandum to All Registered Blood Establishments: Revised Recommendations
for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and
Blood Products, April 23, 1992.

2.

Epstein JS, Jaffe HW, Alter HJ, Klein HG, Blood system changes since recognition of
transfusion-associated AIDS, Transfusion 2013, 53:2365-2374.

3.

Stramer SL, Dodd RY, Transfusion-transmitted emerging infectious disease: 30 years of
challenges and progress, Transfusion 2013, 53:2375-2383.

4.

Dubin C, Francis D, Closing the circle: a thirty-year retrospective on the AIDS/blood
epidemic, Transfusion 2013, 53:2359-2364.

5.

Centers for Disease Control and Prevention, Epidemiologic Notes and Reports
Pneumocystis carinii Pneumonia among Persons with Hemophilia A, MMWR 1982,
31:365-367.

6.

Centers for Disease Control and Prevention, Epidemiologic Notes and Reports Possible
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7.

Ginzburg HM, Intravenous drug users and the acquired immune deficiency syndrome,
Public Health Rep 1984, 99:206-212.

8.

Van de Perre P, Clumeck N, Carael M, Nzabihimana E, Robert-Guroff M, De Mol P,
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infection with human T-cell lymphotropic virus type III, The Lancet 1985, 8454:524-527.

9.

FDA Memorandum: Recommendations to Decrease the Risk of Transmitting Acquired
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10.

Leveton LB, Sox Jr HC, Stoto MA, eds, HIV and the blood supply: an analysis of crisis
decision making, Institute of Medicine, National Academy Press, Washington DC 1995.

11.

Centers for Disease Control and Prevention, Current Trends Prevention of Acquired
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12.

Perkins HA, Busch MP, Transfusion-associated infections: 50 years of relentless
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Centers for Disease Control and Prevention, Update: Revised Public Health Service
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14.

Ward JW, Grindon AJ, Feorino PM, Schable C, Parvin M, Allen JR, Laboratory and
epidemiologic evaluation of an enzyme immunoassay for antibodies to HTLV-III, JAMA
1986, 256:357-361.
22

Contains Nonbinding Recommendations
15.

Zou S, Stramer SL, Dodd RY, Donor testing and risk: current prevalence, incidence, and
residual risk of transfusion-transmissible agents in US allogeneic donations, Transfus
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16.

Klamroth R, Gröner A, Simon TL, Pathogen inactivation and removal methods for
plasma-derived clotting factor concentrates, Transfusion 2014, 54:1406-1417.

17.

FDA Blood Products Advisory Committee Meeting, December 11-12, 1997,
http://www.fda.gov/ohrms/dockets/ac/cber97t.htm

18.

FDA Workshop on Donor Suitability, 1998,
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gsConferences/TranscriptsMinutes/UCM056297.pdf

19.

FDA Blood Products Advisory Committee Meeting, September 14, 2000,
http://www.fda.gov/ohrms/dockets/ac/cber00.htm#Blood%20Prducts

20.

FDA Workshop on Behavior-Based Donor Deferral in the NAT Era, 2006,
http://www.fda.gov/downloads/biologicsbloodvaccines/newsevents/workshopsmeetingsc
onferences/transcriptsminutes/ucm054430.pdf

21.

HHS Advisory Committee on Blood Safety and Availability Meeting, 2010,
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ommendations/06112010_recommendations.pdf

22.

Federal Register Notice, “Request for Information (RFI) on Design of a Pilot Operational
Study To Assess Alternative Blood Donor Deferral Criteria for Men Who Have Had Sex
With Other Men (MSM)” (77 FR 14801, March 13, 2012)
https://www.federalregister.gov/articles/2012/03/13/2012-6091/request-for-informationrfi-on-design-of-a-pilot-operational-study-to-assess-alternative-blood-donor

23.

Kucirka LM1, Sarathy H, Govindan P, Wolf JH, Ellison TA, Hart LJ, Montgomery RA,
Ros RL, Segev DL, Risk of window period HIV infection in high infectious risk donors:
systematic review and meta-analysis, Am J Transplant 2011, 11:1176-1187.

24.

United Kingdom Scientific, SaBTO Advisory Committee on the Safety of Blood, Tissues
and Organs, Donor Selection Criteria Review, April 2011,
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25.

Soriano V, Vispo E, Labarga P, Medrano J, Barreiro P, Viral hepatitis and HIV coinfection, Antiviral Res 2010, 85:303-315.

26.

Purcell DW, Johnson CH, Lansky A, Prejean J, Stein R, Denning P, Gaul Z, Weinstock
H, Su J, Crepaz N, Estimating the population size of men who have sex with men in the
United States to obtain HIV and syphilis rates, Open AIDS J 2012, M6:98-107.

23

Contains Nonbinding Recommendations
27.

CDC, HIV Surveillance Report, 2012; vol 24. Published November 2014,
http://www.cdc.gov/hiv/library/reports/surveillance

28.

CDC, Estimated HIV incidence in the United States, 2007–2010. HIV Surveillance
Supplemental Report 2012; 17(No. 4). Published December 2012.

29.

AABB on Quarantine Release Errors, White Paper 2013,
http://www.aabb.org/research/whitepapers/Documents/quarantine-release-errors-whitepaper.pdf#search=qre

30.

FDA workshop on Quarantine Release Errors in Blood Establishments, September 2011,
http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferen
ces/ucm263117.htm

31.

Advisory Committee on Blood and Tissue Safety and Availability, Results from the
Uniform Donor History Questionnaire, December 2013,
http://www.hhs.gov/ash/bloodsafety/advisorycommittee/acbtsa_201312meeting_agenda.
html

32.

Custer B, Kessler D, Vahidnia F, Leparc G, Krysztof DE, Shaz B, Kamel H, Glynn S,
Dodd RY, Stramer SL; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II),
Risk factors for retrovirus and hepatitis virus infections in accepted blood donors,
Transfusion 2014, doi: 10.1111/trf.12951.

33.

Advisory Committee on Blood and Tissue Safety and Availability, NHLBI Recipient
Epidemiology and Donor Study-III (REDS-III), Noncompliance with the men who have
sex with men (MSM) deferral among U.S. male blood donors, Blood Donation Rules
Opinion Study (BloodDROPS), November 13, 2014,
http://webcast.nccsite.com/nih/0016/.

34.

Benjamin RJ, et al, Deferral of males who had sex with other males, Vox Sanguinis 2011,
101: 339-367.

35.

Offergeld R, et al, Sexual risk behavior and donor deferral in Europe, Vox Sanguinis
2014, 107:420-427.

36.

Seed CR, Kiely P, Law M, Keller AJ, No evidence of a significantly increased risk of
transfusion-transmitted human immunodeficiency virus infection in Australia subsequent
to implementing a 12-month deferral for men who have had sex with men, Transfusion
2010, 50:2722-2730.

37.

Lucky TTA, Seed CR, Waller D, Lee JF, McDonald A, Wand H, Wroth S, Shuttleworth
G, Keller AJ, Pink J, Wilson DP, Understanding noncompliance with selective donor
deferral criteria for high-risk behaviors in Australian blood donors, Transfusion 2014,
54:1739-1749.

38.

Mark KP, Janssen E, Milhausen RR, Infidelity in heterosexual couples: demographic,
interpersonal, and personality-related predictors of extradyadic sex, Arch Sex Behav
2011, 40:971-982.
24

Contains Nonbinding Recommendations
39.

Stone E, Heagerty P, Vittinghoff E, Douglas JM Jr, Koblin BA, Mayer KH, Celum CL,
Gross M, Woody GE, Marmor M, Seage GR III, Buchbinder SP, Correlates of condom
failure in a sexually active cohort of men who have sex with men, J Acquir Immune
Defic Syndr Hum Retrovirol 1999, 20:495-501.

40.

Weller S, Davis-Beaty K, Condom effectiveness in reducing heterosexual HIV
transmission. Cochrane Database of Systematic Reviews 2002. (1):CD003255.

41.

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