Department of Health and Human Services March 13, 2012 – Federal Register Recent Federal Regulation Documents
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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)
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.
Advisory Council on Alzheimer's Research, Care, and Services; Request for Nominations
HHS is soliciting nominations for a new, non-Federal member of the Advisory Council on Alzheimer's Research, Care, and Services to fill the position of ``representative of a state public health department.'' Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre-Dissemination Review Program; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Direct-to- Consumer Television AdvertisementsFDAAA DTC Television Ad Pre- Dissemination Review Program.'' This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre- dissemination review'' is used throughout the guidance to refer to review under the FD&C Act, which is entitled ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make subject to this provision, explains how FDA will notify sponsors that an ad is subject to review under this provision, and describes the general and center-specific procedures sponsors should follow to submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These proposed TV ads will be subject to a 45-calendar day review clock by FDA.
Determination That DURANEST (Etidocaine Hydrochloride) Injection, 0.5%, and Five Other DURANEST Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the DURANEST (etidocaine hydrochloride) drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these drug products if all other legal and regulatory requirements are met.
Agency Information Collection Activities: Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments concerning Form FDA 3792, entitled ``Biosimilars User Fee Cover Sheet.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cooperative Manufacturing Arrangements for Licensed Biologics
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Cooperative Manufacturing Arrangements for Licensed Biologics'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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