Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry.” The guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with revised donor deferral recommendations for individuals at increased risk for transmitting human immunodeficiency virus (HIV) infection. The guidance document recommends corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification, product management, and testing procedures. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2015 and supersedes the memorandum to blood establishments entitled “Revised Recommendations for the Prevention of Human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). While this guidance represents FDA's current thinking on the subject, our recommendations may evolve over time as new scientific evidence becomes available.
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Submit written/paper submissions as follows:
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• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the guidance to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1–800–835–4709 or 240–402–8010. See the
Valerie A. Butler, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911.
FDA is announcing the availability of a document entitled, “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry.” 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
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. On April 23, 1992, FDA issued the 1992 blood memo, which consolidated its recommendations regarding the deferral of donors at risk of HIV, including the deferral for MSM, as well as deferral recommendations for other persons with behaviors associated with high rates of HIV exposure, namely commercial sex workers, those who inject non-prescription drugs, and certain other individuals with HIV risk factors.
The use of donor educational material, specific deferral questions, and advances in HIV donor testing have reduced the risk of HIV transmission from blood transfusion from about 1 in 2500 transfusions prior to HIV testing to a current estimated residual risk of about 1 in 1.47 million transfusions. Since the implementation in 1985 of donor testing for antibodies to HIV, FDA and the U.S. Department of Health and Human Services (HHS) have held a number of public meetings, including public scientific workshops and meetings of the Blood Products Advisory Committee and the HHS Advisory Committee on Blood Safety and Availability (ACBSA) to further review evidence and discuss FDA's blood donor deferral policies to reduce the risk of transmission of HIV by blood and blood products. Consistent with recommendations of the ACBSA in June 2010, studies that might support a policy change were carried out by the Public Health Service in 2011 to 2014. A recommendation for a policy change to the blood donor deferral period for MSM from indefinite deferral to 1 year since the last sexual contact was announced by the Commissioner of Food and Drugs in December 2014. This guidance implements that recommended policy change.
In addition, the guidance provides donor deferral recommendations for other individuals at increased risk for transmitting HIV infection, including commercial sex workers, non-prescription injection drug users, women who have sex with MSM, and certain other individuals with other risk factors. The guidance provides revised recommendations for donor educational materials, donor history questionnaires and accompanying materials, as well as for donor requalification and product management procedures.
In the
Approximately one-half of the comments opposed FDA's time-based deferral policy for MSM and considered the proposed policy to be discriminatory and lacking a scientific rationale. Many of these comments recommended that FDA adopt an individual risk assessment based approach, regardless of an individual's sexual orientation or gender identity. Other comments supported a time-based deferral policy shorter than 1year, or no deferral period at all, because of advances in blood donor testing technologies that permit earlier detection of new HIV infections. Comments requested that FDA commit to reexamining its deferral policies as new technologies, such as pathogen reduction technology are implemented and data regarding compliance with the revised policies become available.
Most of the remaining comments advocated for the continuation of the indefinite deferral policy for MSM and expressed concern regarding the safety of the blood should the revised policy for MSM donors be adopted. Opponents of the proposed change commented on the HIV incidence and prevalence rates among MSM; the potential failure of HIV tests to capture window-period infections; the risk of emerging pathogens for which testing does not exist; and, the potential for decreased compliance rates with the new deferral policy. Other comments argued that FDA should not compromise public health and the safety of the blood supply to satisfy special interest groups.
A smaller number of comments, including those from certain patient advocacy organizations, supported the proposed 1-year deferral policy for MSM predicated on the establishment of a transfusion-transmitted infectious disease monitoring system to enhance safety monitoring and allow rapid responses to emerging threats to the blood supply. Further, similar comments advocated for an evaluation of the effectiveness of the donor educational materials and donor history questionnaires prior to the implementation of new donor deferral policies.
Finally, comments received from the blood industry were generally supportive of the revised MSM donor deferral policy. However, some comments noted that manufacturers of plasma for further manufacturing use (
Finally numerous commenters requested FDA to clarify the recommendation for deferral of women who have had sex with MSM.
FDA carefully considered all of the comments received in response to the draft guidance and the available scientific data, including the results of
In response to comments, FDA made the following changes when finalizing the guidance: (1) Amended the recommendations regarding the inclusion of signs and symptoms associated with HIV in the donor educational materials; (2) revised the recommendation for the deferral of female donors who have had sex with MSM; (3) stated that FDA no longer recommends deferral for individuals who have had sex with an individual with hemophilia or related clotting deficiencies requiring treatment with clotting factor concentrates; and (4) revised the recommendations regarding product retrieval and consignee notification of distributed blood products collected from a donor who should have been deferred for HIV risk factors. In addition, FDA made the following changes to clarify certain recommendations in the guidance, which are consistent with current policy: (1) Clarified that donors who have been determined to have a false-positive HIV test may be reentered according to a requalification method found acceptable to FDA; (2) noted that recipients of allogeneic blood transfusions (
FDA remains committed to exploring options and engaging in public discussions regarding enhancements to donor and public education regarding safe blood donors and evaluating the effectiveness of the donor history questionnaire. Further, with the implementation of a transfusion transmitted infectious disease monitoring system, FDA will be able to monitor donor risk factors and the safety of the blood supply, as well as investigate and refine blood safety measures in the future. FDA's recommendations may evolve over time as new scientific data become available on strategies to maintain or improve blood safety.
The guidance announced in this notice finalizes the draft guidance dated May 2015 and supersedes the 1992 blood memo.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on recommendations for reducing the risk of HIV transmission by blood and blood products. 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.
The guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910–0338; the collections of information in 21 CFR 606.171 have been approved under OMB control number 0910–0458; and the collections of information in 21 CFR 610.46, 630.6, 640.3 and 640.63 have been approved under OMB control number 0910–0116.
Persons with access to the Internet may obtain the guidance at either