This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document.
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA or Agency) is establishing a public docket for comment on the Agency's blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry” dated December 2015. Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.
Submit either electronic or written comments by November 25, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2016-N-1502 for “Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of Public Docket; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Jonathan McKnight, 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.
In the Federal Register of December 23, 2015 (80 FR 79913), FDA announced the availability of the guidance entitled “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry” dated December 2015 (December 2015 guidance) http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf.
The December 2015 guidance updates blood donor deferral recommendations to reflect the most current scientific evidence. The recommendations also help ensure continued safety of the blood supply by reducing the risk of HIV transmission by blood and blood products. As part of the updated blood donor deferral recommendations in the December 2015 guidance, FDA changed the recommendation for an indefinite deferral period for men who have sex with men (MSM) to a deferral period of 12 months since the last sexual contact with another man. The updated recommendations better align the deferral period for MSM with the ( printed page 49674) deferral period for other men and women at increased risk for HIV infection, such as those who had a recent blood transfusion or who have been accidentally exposed to the blood of another individual through a needle stick. In reviewing the Agency's recommendations to reduce the risk of HIV transmission through blood and blood products, FDA rigorously examined several alternative options, including individual risk assessment. Ultimately, FDA concluded that the 12-month deferral period is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population.
As described in the December 2015 guidance, throughout the process of comprehensively updating blood donor deferral policies, FDA has worked with other government Agencies, considered input from external advisory committees, reviewed comments from stakeholders to the draft guidance of the same title (80 FR 27973, May 15, 2015), and carefully examined the most recent available scientific evidence. FDA also has implemented a nationally representative transfusion-transmissible infections monitoring system for the U.S. blood supply with assistance from the National Heart, Lung, and Blood Institute at the National Institutes of Health. This system provides critical information to help inform future actions that FDA may take on blood donor policies.
When FDA issued the December 2015 guidance, it noted that while the December 2015 guidance represents FDA's current thinking on the subject, FDA was committed to continuing to reevaluate and update blood donor deferral policies as new scientific information becomes available. FDA also noted that, because the process must be data-driven, FDA could not specify a time for when future policy changes might occur.
As part of the effort to continue to assess its donor deferral policies, FDA is opening this docket to provide a mechanism for the public to submit additional information regarding potential blood donor deferral policy options. Specifically, we invite interested persons to submit to the docket comments supported by scientific evidence regarding possible revisions to FDA's blood donor deferral policies to reduce the risk of HIV transmission by blood and blood products. FDA requests that commenters provide scientific evidence, such as data from research, to support any suggestions. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility or effectiveness of such alternative deferral policy options.
FDA recognizes that many stakeholders have expressed the desire to move from a time-based deferral period to a deferral policy based on individual risk assessment. An individual risk assessment would involve asking potential donors a series of questions designed to defer donors with high risk behaviors. In particular, we invite commenters to address the following and provide supporting scientific evidence such as data from research:
1. What questions would most effectively identify individuals at risk of transmitting HIV through blood donation?
2. Are there specific questions that could be asked that might best capture the recent risk of a donor acquiring HIV infection, such as within the 2 to 4 weeks immediately preceding blood donation?
3. How specific can the questions be regarding sexual practices while remaining understandable and acceptable to all blood donors? For example, could questions about specific sexual behaviors be asked if they helped to identify which donors should be at least temporarily deferred because of risk factors? To the extent the questions are explicit about sexual practices, how willing will donors be to answer such questions accurately?
4. Under what circumstances would a short deferral period for high risk behavior be appropriate? For each short deferral period identified, please specify the duration of the deferral and provide the scientific rationale.
5. What changes might be necessary within blood collection establishments to assure that accurate, individual HIV risk assessments are performed?
6. How best to design a potential study to evaluate the feasibility and effectiveness of alternative deferral options such as individual risk assessment?
FDA will consider comments and supporting scientific data received as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.
Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17804 Filed 7-26-16; 11:15 am]
BILLING CODE 4164-01-P
680 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.