Pre-I.V.F. Planning Packet

Is there anything I can do to reduce the risk of birth defects in my baby?
We all have a 3-4% background risk to have a baby born with a birth defect, genetic disease or mental retardation, regardless of family history. However, women who take 400 micrograms of folic acid daily, prior to conception and throughout pregnancy, will significantly decrease their risk to have a child born with a neural tube defect. Typically, 400 micrograms of folic acid is the amount that is found in a daily multivitamin. Folic acid may reduce the chance for other birth defects as well.
Neural tube defects are malformations of the brain and spine that occur early in pregnancy. Anencephaly and spina bifida are considered to be neural tube defects. Anencephaly is a fatal condition that is the result of poor development of the skull and brain. Spina bifida refers to malformations of the spinal cord and the bones that form the spine. The health impact of spina bifida varies from person to person. A few individuals with spina bifida are mildly affected and have few health concerns, while others have more severe problems that may include paralysis, loss of bowel and bladder control and learning difficulties. Some studies have shown that folic acid use decreases the risk for these conditions by as much as 70%. For couples with a family history of neural tube defects, a ten-fold increase in the amount of folic acid is warranted, which must be taken under medical supervision. Please talk to your doctor about the amount of folic acid that is right for you.

For more information on folic acid, please click here for an information sheet written by the Centers for Disease Control, titled “Folic Acid Now”.

What are the chances of thaw and pregnancy?
Because we only assist in the match and the adoptors choose their own clinic, statistics are based on the national average OR you may ask your clinic what their success rate is for and FET frozen embryo transfer. (average is 40% chance of thaw 50% chance of pregnancy while embryos frozen in 2007 to present there is a 70 to 90% chance of thaw).

Is Down syndrome inherited?
Down syndrome refers to a disorder that includes mental retardation and other birth defects. Most cases of Down syndrome are not considered to be “inherited” in the sense that a parent passed on the condition to a child due to an intrinsic genetic difference or defect in the parent. Typically, an analysis of human chromosomes (also called a karyotype) reveals a total of 46 chromosomes per cell. Chromosomes come in pairs, and we inherit one chromosome of each pair from our mother and the other chromosome of the pair from our father. This means that an egg cell typically has 23 chromosomes, and a sperm cell has 23 chromosomes, which will then lead to a total of 46 chromosomes in the developing fetus. Occasionally, an accident will occur when a particular egg or sperm cell is made, resulting in an extra or missing chromosome. If the egg or sperm cell has an extra chromosome number 21, the resulting fetus will have an extra chromosome 21, and will be affected with Down syndrome. Down syndrome is also called trisomy 21 because there are three copies of chromosome 21, instead of two copies, in every cell of the body of a person with Down syndrome. In general, the chance that a woman will conceive a child with Down syndrome or another chromosome abnormality increases with age.

There are other, less common forms of Down syndrome. Rarely, healthy individuals can have a rearrangement of their chromosomes, called a balanced translocation, that can increase their chance to have a child with Down syndrome or other chromosome problems.

Even less common is mosaic Down syndrome. This can occur if there is an accident in cell division after fertilization, resulting in a developing fetus has some cells with an extra chromosome 21, and some cells with the typical number of chromosomes. People with mosaic Down syndrome are sometimes less severely affected than people with the other two types of Down syndrome.

How can I ensure that our baby has a blood type consistent with my husband’s or partner’s blood type?
Asthma and allergies are thought to be caused by a complex combination of environmental factors as well as some yet to be identified genetic factors. Offspring of a person with asthma or allergic disease are at approximately a 15% risk to develop asthma or allergic disease as well. If both parents are affected with asthma or allergies, then that risk may be as high as 30% to 50%.

Can a baby’s eye color and hair color be predicted or determined?
The color of a person’s eyes is thought to be the result of the interaction of several different genes. The amount of pigment and its distribution in the eye determines whether a person has brown, hazel, green or blue eyes. The common belief that blue eye color, for example, behaves as a “recessive” to brown eye color is not strictly true. There are many families in which both parents have blue eyes, but their children have brown eyes. The opposite can occur as well. Hair color is inherited in a similar manner to eye color, with many different genes involved. There is no genetic testing that can be done to predict the eye and hair color of children. The chance of having a child with a particular eye or hair color cannot be estimated by knowing the eye and hair color of the parents or other family members, as the genetic aspects of both traits in humans is poorly understood.

Is good eyesight inherited?
The development of the complex shape and structure of the eye is determined by the interaction of many genes that are inherited from both parents. Many different environmental factors are also thought to impact visual acuity. Also, about 50% of all people have decreased visual acuity that requires correction through the use of glasses or contact lenses. Because eyesight is such a complex trait that is influenced by both genetic and environmental factors, and because so many individuals require the use of glasses, accurately predicting the visual acuity of children is not possible.

What is color vision deficiency, and how is it inherited?
About 8-10% of all men have difficulty distinguishing between certain colors. This does not mean that affected individuals see only black and white, or that colors are invisible to them. In the most common type of color vision deficiency, commonly known as color blindness, individuals have a hard time distinguishing certain shades of red and green. This type of color vision deficiency is inherited as an X-linked trait.

X-linked inheritance means that the gene causing the trait is located on the X chromosome. Women have two X chromosomes and men have one X chromosome and one Y chromosome. The Y chromosome predominantly carries genes that are responsible for male development and it does not contain genes that are responsible for color vision. If a man inherits an X chromosome with a gene on it that causes color blindness, that man will be affected. If a woman inherits an X chromosome with a gene on it that causes color blindness, she will likely have a working copy of that same gene on her other X chromosome and will have normal color vision.

Therefore, if a donor is color blind, he has one X chromosome with the gene for color blindness and one Y chromosome that does not contain any genes on it related to color vision. The donor will only pass on his Y chromosome to his male offspring. As long as the recipient is not a carrier of the gene for color blindness, all the donor’s male offspring will have normal color vision. The donor will only pass on his X chromosome to his female offspring, which will contain the gene for color blindness. As long as the recipient is not a carrier for the gene for color blindness, all the donor’s female offspring will have normal color vision but will be carriers of the gene for color blindness. This means that when female offspring of the colorblind donor are ready to have children of their own, their male children will have a 50% chance of having color blindness.

Is acne genetic?
The cause of acne is unknown. Acne is very common among adolescents, occurring to some degree in approximately 80% of all teens. It is not currently possible to predict whether or not any child will have acne, regardless of family history.

Is alcoholism genetic?
People often have concern about whether the offspring of an alcoholic is at greater risk of becoming an alcoholic. While it is true that children of alcoholics are at greater risk, and alcoholism can appear to “run through” families, the exact cause of alcoholism is uncertain. Currently, it is thought that a complex interaction between genes and environment play a role in shaping a person’s risk for alcoholism. Genetic factors may include the rate at which a person metabolizes alcohol, or differences in the type and number of certain brain receptors. Environmental factors can include the way children model their parent’s behaviors and coping mechanisms, and the availability and pattern of the use of alcohol within a family or peer group. Currently, genetic screening is not available to predict whether or not a person is at higher risk to develop problem drinking patterns.

Is cancer genetic?
Cancer is a very common group of diseases; it is estimated that 1 out of every 3 Americans will develop cancer at some point during their lifetime. All cancers are due to genetic changes that occur in the cells that make up the tumor. Most people who develop cancer acquire these genetic changes in their cells over the course of their life due to the effects of aging and environmental factors; this is often referred to as “sporadic” cancer. However, approximately 5-10% of people who develop cancer will do so because they have inherited a genetic alteration. This genetic alteration is present in every cell of their body, not just in the tumor cells as is seen in “sporadic” cancers. Typically, people who have inherited a genetic alteration that predisposes toward the development of cancer have some noticeable differences from people who develop sporadic cancer. People with an inherited genetic alteration tend to develop cancer at a much earlier age, are more likely to have had more than one cancer develop over their lifetime, and tend to have other family members who have also developed the same type of cancer or a related type of cancer. Donor family histories are analyzed for these features of hereditary cancer syndromes.

Are traits such as athleticism, creativity, writing skill and mathematical talent inherited?
All of the traits mentioned are considered to be multifactorial. This means that it’s likely that there is some genetic contribution, combined with environmental factors, which influence the expression and degree of expression of these traits. Currently, there is no way to predict or estimate a child’s likelihood to express any of these traits based on the apparent expression of these traits in the parent. There is also no genetic testing available for these traits.

Do we perform psychological testing on our donors?
California Cryobank provides Keirsey Temperament Sorter results to clients on some of our donors. This test does not provide any information on the donor’s current mental health or his risk to develop any particular type of neuropsychiatric illness. The Keirsey Temperament Sorter provides our clients with some insight into the donor’s temperament and his personal style when interacting with others. It cannot predict the general temperament of the donor’s offspring, because personality and social behavior are influenced by environmental factors. No one, regardless of the method of reproduction, can predict the temperament, interests, skills and talents of their children.

Is major mental illness genetic?
Neuropsychiatric illnesses, such as bipolar disorder and schizophrenia, are considered to be multifactorial in origin. This means that while it is likely that people who develop these illnesses have an underlying aggregation of several genes that make them susceptible, environmental factors also likely played a role in triggering the disorder. Currently, the specific causes of these illnesses are poorly understood, and there are no clinical genetic tests available that can predict a person’s risk to develop these conditions. A good resource for more information on mental illness is the National Institute for Mental Health’s website: http://www.nimh.nih.gov/home.cfm"

Q and A 2005 Donor Eligibility FDA Final Rule and Draft Guidance
http://www.fda.gov/cber/rules/suitdonorq&a.htm

Center for Biologics Evaluation and Research, U.S. Food and Drug Administration


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CBER
CBER
Questions and Answers
for Roll-Out of Donor Eligibility Final Rule and Draft Guidance

Information updated 6/14/2005

What is the purpose of this rule?

FDA is finalizing its proposed requirements to screen and test donors of human cell, tissue, and cellular and tissue-based products (HCT/Ps) for risk factors for, and clinical evidence of, relevant communicable disease agents or diseases [1271.1(a)]. FDA believes that these requirements will increase the safety of HCT/Ps, and public confidence in their safety, by preventing the introduction, transmission and spread of communicable disease.

Has FDA issued other rules regarding HCT/Ps?

Yes. FDA is publishing a set of 3 rules in order to implement its proposed approach to the regulation of HCT/Ps, which was announced in 1997. The 3 rules were published as proposed rules for comment. The first rule on registration and listing was finalized on January 19, 2001. By March 29, 2004, FDA expected all establishments that recover, process, store, label, package or distribute HCT/P, or that screen or test the donor of the HCT/P, to be registered with FDA and list their HCT/Ps. The donor eligibility rule (DE rule) is the second rule to be finalized. FDA is in the process of finalizing the third rule on current good tissue practice (GTP rule), which was proposed on January 8, 2001.

When will the donor eligibility rule become effective?

This rule will become effective on May 25, 2005. At that time, FDA intends to have finalized and published the GTP rule. Both rules would become effective at the same time. FDA chose a 12-month effective date to allow the DE and GTP rules to become effective at the same time and to provide sufficient time for training and implementation to ensure effective compliance.

Will the requirements in this rule apply to HCT/Ps procured before the effective date?

No. The requirements apply to HCT/Ps procured on or after the effective date.

Doesn't FDA already have requirements for tissue donor screening and testing?

Yes. Since 1993, FDA has been regulating human tissue intended for transplantation under 21 CFR 1270. Part 1270 contains requirements for determining the suitability of a donor of human tissue intended for transplantation, as well as requirements for written procedures, record keeping and inspection. These requirements apply to certain tissues (musculoskeletal, skin, and ocular) and certain diseases (HIV, hepatitis B and hepatitis C).

How will this new rule be different? Who will it apply to?

The new rule, codified in 21 CFR 1271 (subpart C), will cover donors of additional cells and tissues and will require screening and testing of these donors for additional communicable diseases [1271.1(b)]. For instance, the new rule will apply to donors of hematopoietic stem/progenitor cells derived from peripheral and umbilical cord blood (e.g., cord blood); reproductive cells and tissue (e.g., semen, oocyte, embryo), human dura mater, and human heart valves, in addition to donors of musculoskeletal, skin, and ocular tissue. The new rule will also apply to donors of biological products and medical devices that contain or consist of human cells or tissue [1271.3(d)].

What is meant by a "donor eligibility determination"?

A donor eligibility determination is based on screening and testing the donor for certain communicable disease agents and diseases, which we term "relevant communicable disease agents and diseases." A donor eligibility determination is required for all donors, with some exceptions [1271.45(b)]. An HCT/P cannot be administered to a patient until the donor has been determined to be eligible, with some exceptions [1271.45(c)].

What is a "relevant communicable disease agent or disease"?

The rule identifies specific diseases and disease agents, which are relevant to all HCT/Ps. It also identifies specific diseases and disease agents, which are relevant only to certain kinds of HCT/Ps (i.e., because there is a risk of transmission only through certain HCT/Ps) [1271.3(r)(1)].

In addition, other disease agents or diseases may meet the following criteria to be considered a "relevant communicable disease agent or disease":

* There is a risk of transmission of the disease agent or disease by the HCT/P to the recipient or others who come in contact with the tissue, because it has sufficient incidence or prevalence in the potential donor population or may have been released accidentally or intentionally to place potential donors at risk.

* The relevant communicable disease agent is fatal or life-threatening, results in permanent impairment or damage, or necessitates medical or surgical intervention.

* There are appropriate screening measures developed and/or appropriate donor screening tests approved by FDA for the disease agent [1271.3(r)(2)].

FDA issued draft guidance at the same time as the rule, stating that FDA believes that the following diseases meet these criteria-- West Nile Virus, Severe Acute Respiratory Syndrome (SARS), Vaccinia (the agent in the smallpox vaccine) and Sepsis. Accordingly, in the draft guidance FDA recommends that establishments screen donors for these diseases.

How is a potential donor determined to be eligible?

A potential donor is determined to be eligible if donor screening indicates that the donor is free from risk factors for, and clinical evidence of, infection due to a relevant communicable disease agent or disease, is free from communicable disease risks associated with xenotransplantation, and the results of testing for relevant communicable disease agents or diseases are negative [1271.50]. The specific risk factors, clinical and physical evidence, and tests that we recommend are detailed in the draft guidance that has been published along with this rule.

Who makes the donor eligibility determination?

A responsible person makes this determination [1271.50(a)]. A responsible person is one who is authorized, trained and qualified to perform this task [1271.3(t)].

What happens to the HCT/P before the donor eligibility determination is made?

The HCT/P from this donor is kept "in quarantine." This means that the HCT/P is identified in some manner to prevent its improper release [1271.3(q)]. An HCT/P in quarantine can still be shipped, provided that it is accompanied by records containing a distinct identification code and indicating that the determination has not been completed and that the HCT/P should not be administered [1271.60].

Can you ever administer an HCT/P if the donor eligibility determination has not been completed?

Yes, if there is an urgent medical need for the HCT/P [1271.60(d)]. This means that no comparable HCT/P is available and the recipient is likely to die or suffer serious morbidity with this HCT/P [1271.3(u)]. If you make an HCT/P available for use under urgent medical need, you must label it with special labels [1271.60(d)(2)]. The HCT/P must be accompanied by the results of any screening and testing that has been performed and a list of required screening and testing that has not yet been completed [1271.60(d)(2)]. You must document that you notified the physician using the HCT/P that the testing and screening were not complete [1271.60(d)(3)].

What happens to an HCT/P from a donor determined to be ineligible?

An HCT/P from a donor who is determined to be ineligible must be stored or identified in a manner that will prevent its improper release, until the HCT/P is destroyed or disposed of in another way (e.g., for nonclinical purposes) [1271.65(a)].

Is an HCT/P from an ineligible donor always prohibited from being used?

No. There are some situations where such an HCT/P is not prohibited from use. For example, the HCT/P may be used in a first-degree or second-degree blood relative. Reproductive cells or tissue from a directed reproductive donor (i.e., the donor and recipient know each other before donation) may be used. If there is an urgent medical need, the HCT/P may be used. The HCT/P must have special labeling, and the physician must be notified of the results of screening and testing [1271.65(b)].

What does "donor screening" mean?

Donor screening consists of reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [1271.75]. These records include a current donor medical history interview (with the donor or another individual who is able to provide information about the donor's medical history and relevant social behavior), a current physical assessment, and, if available, medical records, laboratory test results, coroner and autopsy reports, and records or other information received from any source pertaining to risk factors for relevant communicable disease (e.g., social behavior, clinical signs and symptoms of relevant communicable disease, and treatments related to medical conditions suggestive of risk for relevant communicable disease [1271.3(s)].

For which relevant communicable disease agents and diseases are all HCT/P donors screened?

All HCT/P donors (with some exceptions) are screened for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases, including HIV, hepatitis B, hepatitis C, human transmissible spongiform encephalopathy (e.g., Creutzfeldt-Jakob Disease), and Treponema pallidum (the agent of syphilis) [1271.75(a)]. Risk factors for, clinical evidence of, and physical evidence of these diseases are discussed in the draft guidance accompanying this rulemaking. Risk factors for human transmissible spongiform encephalopathy are discussed in a specific draft guidance entitled, "Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" [67 FR 42789, June 25, 2002]. We intend to issue a single final guidance document that incorporates the draft guidance on CJD and vCJD and the draft guidance accompanying this rule into a final guidance on donor eligibility determination.

In addition to the above, for which relevant communicable disease agents and diseases are donors of viable, leukocyte-rich cells and tissue screened?

Donors of viable, leukocyte-rich cells and tissues (these are listed in the draft guidance for comment) are screened for risk factors for, and clinical evidence of relevant cell-associated communicable disease agents and diseases, including human T lymphotropic virus (HTLV), in addition to those listed in the previous response [1271.75(b)].

For which relevant communicable disease agents and diseases are all HCT/P donors tested?

All HCT/P donors are tested for HIV-1, HIV-2, hepatitis B, hepatitis C, and Treponema pallidum [1271.85(a)]. The specific tests that are recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease are discussed in the draft guidance.

In addition to the above, for which relevant communicable disease agents and diseases are donors of viable, leukocyte-rich cells and tissues tested?

Donors of viable, leukocyte-rich cells and tissue (identified in the draft guidance) are tested for HTLV-I and II, in addition to those listed in the previous response [1271.85(b)(1)]. Also, although Cytomegalovirus (CMV) is not a relevant communicable disease, these donors must be tested for evidence of infection due to CMV, and procedures governing the release of an HCT/P from a CMV-positive donor must be developed [1271.85(b)(2)].

When must you collect a specimen from the donor, to be used for testing for relevant communicable diseases?

You must collect the donor specimen at the time of recovery of the cells or tissue. However, if collection at the time of recovery is not feasible, then you may collect the specimen up to 7 days before or after recovery or, for donors of peripheral blood stem/progenitor cells, oocytes and minimally manipulated bone marrow, up to 30 days before recovery [1271.80(b)].

Where must the testing be performed?

A laboratory that either is CLIA-certified or has met equivalent requirements, as determined by the Centers for Medicare and Medicaid, must perform required testing [1271.80(c)].

What type of test must be used?

You must use an appropriate FDA-licensed, approved, or cleared donor screening test, according to the manufacturer's instructions. If applicable, a test specifically labeled for cadaveric specimens must be used when available [1271.80(c)].

Is plasma dilution a consideration when performing the test on a post-mortem specimen?

Yes. You must consider a donor ineligible if plasma dilution sufficient to affect the results of communicable disease testing is suspected, unless you test a pre-transfusion specimen or use an appropriate algorithm designed to evaluate volumes of fluids administered in the 48 hours before specimen collection, and the algorithm shows that plasma dilution sufficient to affect test results has not occurred [1271.80(d)(2)]. An example of an algorithm is given in the draft guidance for comment.

What records must accompany an HCT/P after the donor eligibility determination is complete?

The accompanying records must include, at a minimum, a distinct identification code that relates the HCT/P to the donor, a statement that the donor has been determined to be eligible or ineligible, and a summary of records used to make the donor eligibility determination. The records must not contain any information that might identify the donor, except in the case of autologous or directed reproductive donations or donations made by first-degree or second degree blood relatives [1271.55].

How long must records of the donor eligibility determination be kept?

Records pertaining to a particular HCT/P must be retained for 10 years after the date of administration, or if this date is not known, then at least 10 years after the date of distribution, disposition, or expiration of the HCT/P, whichever is later [1271.55(d)].

What procedures must you have regarding the donor eligibility determination?

You must have procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with other requirements in this rule. Before implementing these procedures, a responsible person must review and approve them. The procedures must be available to the personnel. You may use standard procedures prepared by another organization, provided they are consistent with and as stringent as the requirements in this rule [1271.47].

REPRODUCTIVE CELLS AND TISSUES

What specific exceptions does this rule have for donors of reproductive cells and tissues?

* The final rule does not require a 6-month quarantine for donations and retesting of directed semen donors [1271.85(d)].

* The rule does not prohibit the use of reproductive cells and tissue from directed donors determined to be ineligible [1271.65(b)(ii)].

* Donors who are sexually intimate partners are not required to be screened or tested [1271.90(a)(2)].

* Testing and screening of sexually intimate partners who later decide to donate embryos is not required; however, when possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of the embryos to a recipient. [1271.90(a)(4)]

* Under certain circumstances, cryopreserved reproductive cells and tissue, other than embryos, can be used for directed donation, even if the donor(s) were not screened and tested initially, provided that appropriate measures are taken to screen and test the donor(s) before transfer to the recipient [1271.90(a)(3)].

* For anonymous semen donors who make repeated donations, you may perform an abbreviated history [1271.75(e)], and you are not required to collect and test a blood specimen at each donation, provided that complete donor screening and testing is performed at least every 6 months [1271.85(d)].

In addition to the requirements for all HCT/P donors, for which relevant communicable disease agents and diseases are donors of reproductive cells and tissues screened and tested?

Anonymous and directed semen and oocyte donors, and certain embryo donors, are screened and tested for relevant genitourinary disease agents, including Chlamydia trachomatis and Neisseria gonorrhea, at the time of donation. However, anonymous and directed oocyte donors would be exempt from such testing when oocytes are retrieved in a way that ensures freedom from contamination with these disease agents (e.g., nonvaginal laparoscopy). Anonymous and directed semen donors are also screened and tested for HTLV and CMV, because semen is considered leukocyte-rich [1271.85(c)].

What special requirements apply to anonymous semen donors?

Anonymous semen donors who make repeated donations may undergo abbreviated donor screening at each donation to identify any change to risk factors for, and clinical evidence of, relevant communicable disease agents and diseases since the last donation. Complete donor screening and testing is required every six months [1271.75(e)].

Semen from anonymous donors must be quarantined for at least six months, at which time the donor must be re-tested [1271.85(d)].

What special requirements apply to directed semen donors?

Directed semen donors must be tested at the time of donation, but do not have to be retested 6 months later (as do anonymous semen donors) [1271.85(d)]. Directed donation of fresh semen is allowed. The term "directed reproductive donor" means a reproductive donor who knows and is known by the recipient before donation [1271.3(l)]. Directed donations from donors who test positive or indicate a risk factor for a relevant communicable disease are not prohibited from use. Special labeling of the HCT/P is required to indicate increased risk of relevant communicable disease [1271.65(b)].

Do sexually intimate partners have to be screened and tested?

No. However, special labeling of the HCT/P is required [1271.90(a)(2)].

horizontal rule

DRAFT GUIDANCE

What is the purpose of the draft guidance?

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on eligibility for donors of human cells, tissues, and cellular and tissue-based products. In guidance, FDA provides recommendations for complying with the requirements contained in the donor eligibility rule.

Will it supersede the current Guidance for Industry, published in 1997?

No. The 1997 guidance will remain in effect, but will apply to donors of HCT/Ps procured prior to the effective date of the rule.

Will I have an opportunity to comment on the draft guidance?

Yes. Although comments on a guidance document may be made at any time, we have requested that comments be made within 90 days, in order to assure that the comment will be considered as the agency drafts a final guidance.

Why are additional relevant communicable diseases listed in the draft guidance-they are not in the rule?

In the rule, we define relevant communicable diseases, identify certain relevant communicable diseases, and list criteria that must be met for another disease to be considered a relevant communicable disease. We list HIV, HBV, HCV, human transmissible spongiform encephalopathies, including CJD, and syphilis as relevant communicable diseases for all donors; HTLV for donors of leukocyte-rich HCT/Ps; and Chlamydia trachomatis and Neisseria gonorrhea for donors of reproductive cells and tissues. These diseases were proposed in the proposed donor suitability rule. Consistent with good guidance practices, when FDA believes a "new" disease agent or disease meets criteria specified in the rule, the agency ordinarily obtains public comment by identifying the new disease in draft guidance and explaining how, in FDA's view, the new disease meets those criteria. Comments on the draft guidance would be considered in any final guidance on the subject. The additional relevant communicable diseases identified in the draft guidance issued for comment today are West Nile Virus (WNV), SARS, Vaccinia (smallpox vaccination) and Sepsis. FDA believes that these diseases meet the criteria for inclusion as relevant communicable diseases, and explains the reasons in the draft guidance.

What do I do if I have questions?

If you have questions, please contact the Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 800-835-4709 or 301-827-1800. Questions may also be submitted via e-mail to tissuereg@cber.fda.gov (industry) or octma@cber.fda.gov (consumers and health care professionals).


Updated June 16, 2005


FDA / Center for Biologics Evaluation and Research
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May 2005 FDA Eligibility Determination for Donors of Human Cells, Tissue Feb 2007 http://www.fda.gov/cber/rules/suitdonorq&a.htm#4
Link to pdf report FDA Guidelines
http://www.fda.gov/cber/gdlns/tissdonor.pdf

When did the donor eligibility rule become effective?

The donor eligibility rule became effective on May 25, 2005. FDA chose a 12-month effective date to provide sufficient time for training and implementation to ensure compliance.

Do the requirements in this rule apply to HCT/Ps recovered before the effective date?

The requirements apply to HCT/Ps recovered on or after the effective date of May 25, 2005.

Did FDA already have requirements for tissue donor screening and testing prior to the donor eligibility rule?

FDA has regulated human tissue intended for transplantation under 21 CFR 1270, since 1993. Part 1270 contains requirements for determining the suitability of a donor of human tissue intended for transplantation, as well as requirements for written procedures, record keeping and inspection. These requirements apply to certain tissues (e.g., musculoskeletal, skin, vascular, and ocular) recovered prior to May 25, 2005 and certain diseases (HIV, hepatitis B and hepatitis C).

Who does the donor eligibility rule apply to?

The donor eligibility rule, codified in 21 CFR 1271 (subpart C), applies to donors of HCT/Ps recovered on or after May 25, 2005, and requires screening and testing of donors for risk factors for, and clinical evidence of, infection due to relevant communicable disease agents and diseases [1271.1(b)]. For instance, the rule applies to donors of hematopoietic stem/progenitor cells derived from peripheral and umbilical cord blood (e.g., cord blood); reproductive cells and tissue (e.g., semen, oocyte, embryo), human dura mater, and human heart valves, in addition to donors of musculoskeletal, skin, vascular, and ocular tissue. The donor eligibility rule also applies to donors of HCT/Ps regulated as drugs, devices, and/or biological products under the Federal Food Drug and Cosmetic (FD&C) Act or section 351 of the Public Health Service Act.