81 FR 89949 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System-Risk Factor Elicitation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 239 (December 13, 2016)

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89949-89950]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2836]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Donor Risk Assessment 
Questionnaire for the Food and Drug Administration/National Heart, 
Lung, and Blood Institute-Sponsored Transfusion-Transmissible 
Infections Monitoring System--Risk Factor Elicitation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
12, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--New and 
title ``Donor Risk Assessment Questionnaire for the Food and Drug 
Administration/National Heart, Lung, and Blood Institute-sponsored 
Transfusion-Transmissible Infections Monitoring System--Risk Factor 
Elicitation.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
    Donor Risk Assessment Questionnaire for FDA/National Heart, Lung, 
and Blood Institute (NHLBI)-sponsored Transfusion-Transmissible 
Infections Monitoring System (TTIMS)--Risk Factor Elicitation OMB 
Control Number--New
    FDA intends to interview blood donors to collect risk factor 
information associated with testing positive for a Transfusion-
Transmissible Infection (TTI). This collection of information is part 
of a larger initiative called TTIMS, which is a collaborative project 
funded by FDA, the NHLBI of the National Institutes of Health (NIH), 
and the Department of Health and Human Services (HHS) Office of the 
Assistant Secretary of Health with input from other Agencies in HHS, 
including the Centers for Disease Control and Prevention (CDC). FDA 
will use these scientific data collected through such interview-based 
risk factor elicitation of blood donors to monitor and help ensure the 
safety of the U.S. blood supply.
    Previous assessments of risk factor profiles among blood donors 
found to be positive for human immunodeficiency virus (HIV) were funded 
by CDC for approximately 10 years after implementation of HIV serologic 
screening of blood donors in the mid-1980s; whereas studies of 
Hepatitis C virus (HCV) seropositive donors, funded by NIH, were 
conducted in the early 1990s. Information on current risk factors in 
blood donors as assessed using analytical study designs was next 
evaluated by the Transfusion-Transmitted Retrovirus and Hepatitis Virus 
Rates and Risk Factors Study conducted by the NHLBI Retrovirus 
Epidemiology Donor Study-II (REDS-II) approved under OMB control number 
0925-0630. Through a risk factor questionnaire, this study elicited 
risk factors in blood donors who tested confirmed positive for one of 
four transfusion-transmissible infections: HIV, HCV, Hepatitis B virus 
(HBV), and Human T-cell Lymphotropic virus. The study also elicited 
risk factors from donors who did not have any infections (controls) and 
compared their responses to those of the donors with confirmed 
infection (cases). Results from the REDS-II study were published in 
2015.
    FDA issued a document entitled ``Revised Recommendations for 
Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood 
and Blood Products, Guidance for Industry'' dated December 2015 (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf) 
that changed the blood donor criterion for men who have sex with men 
(MSM) from an indefinite (permanent) deferral to a 12-month deferral 
since last MSM contact. The impact of this change in the deferral 
criteria requires a national monitoring effort as part of TTIMS to 
assess if the relative proportions of risk factors for infection in 
blood donors have changed following the adoption of the 12-month donor 
deferral for MSM. TTIMS will use similar procedures as the ones used in 
the REDS-II study to monitor and evaluate risk factors among HIV-
positive donors and recently HCV or HBV infected donors as well as 
controls.
    This study will help identify the specific risk factors for TTI and 
their prevalence in blood donors, and help inform FDA on the proportion 
of incident (new) infections among all HIV positive blood donors. 
Donations with incident infections have the greatest potential 
transmission risk because they could be missed during routine blood 
screening. The study will help FDA evaluate the effectiveness of 
screening strategies in reducing the risk of HIV transmission from at-
risk donors and to evaluate if there are unexpected consequences 
associated with the recent change in donor deferral policy such as an 
increase in HIV incidence among donors. These data also will inform FDA 
regarding future 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, and 
to inform the design of potential studies to evaluate the feasibility 
and effectiveness of such alternative deferral options.
    TTIMS will include a comprehensive interview based epidemiological 
study of risk factor information for viral infection-positive blood 
donors at the American Red Cross (ARC), Blood Systems, Inc. (BSI), New 
York Blood Center (NYBC), and OneBlood that will identify the current 
predominant risk factors and reasons for virus-positive donations. The 
TTIMS program establishes a new, ongoing donor hemovigilance capacity 
that currently does not exist in the United States. Using procedures 
developed by the REDS-II study, TTIMS will establish this capacity in 
greater than 50 percent of all blood donations collected in the 
country.
    As part of the TTIMS project, a comprehensive hemovigilance 
database will be created that integrates the risk

[[Page 89950]]

factor information collected through donor interviews of blood donor 
with the resulting data from disease marker testing and blood 
components collected by participating organizations into a research 
database. Following successful initiation of the risk factor 
interviews, the TTIMS network is poised to be expanded to include 
additional blood centers and/or re-focused on other safety threats as 
warranted. In this way, the TTIMS program will maintain standardized, 
statistically and scientifically robust processes for applying 
hemovigilance information across blood collection organizations.
    The specific objectives are to:
     Determine current behavioral risk factors associated with 
all HIV infections, incident HBV, and incident HCV infections in blood 
donors (including parenteral and sexual risks) across the participating 
blood collection organizations using a case-control study design.
     Determine infectious disease marker prevalence and 
incidence for HIV, HBV, and HCV overall and by demographic 
characteristics of donors in the majority of blood donations collected 
in the country. This will be accomplished by forming epidemiological 
databases consisting of harmonized operational data from ARC, BSI, 
NYBC, and OneBlood.
     Analyze integrated risk factor and infectious marker 
testing data concurrently because when taken together these may suggest 
that blood centers are not achieving the same degree of success in 
educational efforts to prevent donation by donors with risk behaviors 
across all demographic groups.
    The respondents will be persons who donated blood in the United 
States and these participants will be defined as cases and controls. 
The estimated number of respondents is based on an overall expected 
participation in the risk factor survey. We estimate a case to control 
ratio of 1:2 (200 to 400) with a 50 percent case enrollment.
    In the Federal Register of September 30, 2016 (81 FR 67358), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received a few comments from the public. 
FDA concurs with one comment that providing more information to the 
blood center and FDA may aid in prevention of transmission of 
infectious disease and is critical to the safety of the blood supply. 
Four comments received were not responsive to the comment request on 
the four specified aspects of the collection of information. None of 
the responses specifically commented on any of the proposed questions, 
nor did they request that FDA make any other changes to the Donor Risk 
Assessment Questionnaire. Furthermore, the responses did not provide 
any data or explanation that would support a change regarding the 
information collection requirements.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
     Questionnaire/survey          Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Cases and controls \2\........             600               1             600  0.75 (45                     450
                                                                                 minutes).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Cases consist of virus-positive donations, and controls represent uninfected donors.


    Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29814 Filed 12-12-16; 8:45 am]
 BILLING CODE 4164-01-P