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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)
Notices
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Department of Health and Human Services
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United States Government Agency or Subagency
The Department of Health and Human Services (HHS) is seeking to identify interest and obtain information relevant to the design of a pilot operational study (or studies) on alternative donor deferral criteria that would permit blood and plasma donations (subsequently termed ``blood donations'') by men who have had sex with other men (MSM). Based upon documented higher levels of certain transfusion- transmissible infections (e.g. Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV)) in some groups of men who have had sex with men, all men with a history of this behavior since 1977 are currently deferred from donating blood. However, the increased effectiveness of donor testing for HIV, HBV, syphilis and other infectious agents has greatly enhanced blood safety. As a result, questions have been raised about the need to continue an indefinite deferral of all MSM and whether there could be blood donation by MSM who may not be at increased risk. In June 2010, HHS sought advice from its Advisory Committee for Blood Safety and Availability (ACBSA) on the issue of the current MSM deferral policy. The Advisory Committee noted that the existing policy is suboptimal, but recommended that the policy should be retained pending the completion of targeted research studies that might support a safe alternative policy. HHS and the agencies responsible for blood safety are committed to efforts to maintain and enhance the safety of the nation's blood supply, taking into account all new and emerging scientific information. Consistent with the June 2010 recommendations of the ACBSA, HHS seeks to determine through appropriate studies whether blood safety can be maintained or enhanced under revised blood donor screening criteria that would permit donation by some MSM. This request for information (RFI) is being issued in recognition of the challenges of designing such studies. This RFI seeks information from interested parties regarding the design, logistics and feasibility of a pilot operational study (or studies) to assess alternative blood donor eligibility criteria for MSM. Responses to this RFI will inform HHS on the design, logistics and feasibility of such a study, which, if feasible, could result in identifying potential pathways toward future alternate policies that will maintain or enhance the current very high levels of blood safety. The concept is to conduct a pilot operational study, in which MSM who meet specified criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients during the course of the study. Data would be gathered to assess the effectiveness of the specified criteria to select low risk donors among MSM. Upon completing all data collection activities, there will be a transparent and evidence-based evaluation of current and possible future MSM blood donation policies. This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of HHS. HHS does not intend to award a grant or contract to pay for the preparation of any information submitted or for the use of such information by HHS. Whereas all responses to this notice will be carefully considered, acknowledgment of receipt of responses will not be made, nor will respondents be notified of the evaluation by HHS of the information received. No basis for claims against HHS shall arise as a result of a response to this request for information or to the use of such information by HHS as either part of our evaluation process or in developing specifications for any subsequent announcement.
77 FR 14801
https://www.govinfo.gov/app/details/FR-2012-03-13/2012-6091
2012-6091
fr13mr12-66
4150-41-P
https://www.govinfo.gov/app/details/FR-2012-03-13/2012-6091
https://www.govinfo.gov/content/pkg/FR-2012-03-13/html/2012-6091.htm
https://www.govinfo.gov/content/pkg/FR-2012-03-13/pdf/2012-6091.pdf
4 p.
14801
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77 FR 14801
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); Federal Register Vol. 77, Issue
NOTICE
2012-6091
DEPARTMENT OF HEALTH AND HUMAN SERVICES
4150-41-P
2012-6091
Notice.
The Department of Health and Human Services (HHS) is seeking to identify interest and obtain information relevant to the design of a pilot operational study (or studies) on alternative donor deferral criteria that would permit blood and plasma donations (subsequently termed ``blood donations'') by men who have had sex with other men (MSM). Based upon documented higher levels of certain transfusion- transmissible infections (e.g. Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV)) in some groups of men who have had sex with men, all men with a history of this behavior since 1977 are currently deferred from donating blood. However, the increased effectiveness of donor testing for HIV, HBV, syphilis and other infectious agents has greatly enhanced blood safety. As a result, questions have been raised about the need to continue an indefinite deferral of all MSM and whether there could be blood donation by MSM who may not be at increased risk. In June 2010, HHS sought advice from its Advisory Committee for Blood Safety and Availability (ACBSA) on the issue of the current MSM deferral policy. The Advisory Committee noted that the existing policy is suboptimal, but recommended that the policy should be retained pending the completion of targeted research studies that might support a safe alternative policy. HHS and the agencies responsible for blood safety are committed to efforts to maintain and enhance the safety of the nation's blood supply, taking into account all new and emerging scientific information. Consistent with the June 2010 recommendations of the ACBSA, HHS seeks to determine through appropriate studies whether blood safety can be maintained or enhanced under revised blood donor screening criteria that would permit donation by some MSM. This request for information (RFI) is being issued in recognition of the challenges of designing such studies. This RFI seeks information from interested parties regarding the design, logistics and feasibility of a pilot operational study (or studies) to assess alternative blood donor eligibility criteria for MSM. Responses to this RFI will inform HHS on the design, logistics and feasibility of such a study, which, if feasible, could result in identifying potential pathways toward future alternate policies that will maintain or enhance the current very high levels of blood safety. The concept is to conduct a pilot operational study, in which MSM who meet specified criteria would be permitted to donate blood, with additional safeguards in place to protect blood recipients during the course of the study. Data would be gathered to assess the effectiveness of the specified criteria to select low risk donors among MSM. Upon completing all data collection activities, there will be a transparent and evidence-based evaluation of current and possible future MSM blood donation policies. This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of HHS. HHS does not intend to award a grant or contract to pay for the preparation of any information submitted or for the use of such information by HHS. Whereas all responses to this notice will be carefully considered, acknowledgment of receipt of responses will not be made, nor will respondents be notified of the evaluation by HHS of the information received. No basis for claims against HHS shall arise as a result of a response to this request for information or to the use of such information by HHS as either part of our evaluation process or in developing specifications for any subsequent announcement.
All responses must be received no later than 4 p.m. EDT on June 11, 2012 at the address listed below.
James Berger, Acting Director for Blood Safety and Availability, Office of the Assistant Secretary for Health, Office of the Secretary, U.S. Department of Health and Human Services, 1101 Wootton Parkway, Tower Building, Suite 250, Rockville, MD 20852.
Design of Pilot Operational Studies; Request for Information:
Assessment of Alternative Blood Donor Deferral Criteria for Men Who Have Had Sex with Other Men
,
http://www.cdc.gov/hiv/surveillance/resources/reports/2009report/index.htm
http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/UCM054430.pdf
http://www.fda.gov/ohrms/dockets/ac/cber00.htm#Blood%20Prducts
http://www.hhs.gov/ash/bloodsafety/advisorycommittee/recommendations/msm-deferral_qa_20110722-final.pdf
http://www.regulations.gov
Federal Register
Vol. 77, no. 49
Office of the Federal Register, National Archives and Records Administration
2012-03-13
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