[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 42001-42002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15009]



[[Page 42001]]

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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: Submit written comments (including recommendations) on the 
collection of information by August 12, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0841. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 (RFE)

OMB Control Number 0910-0841--Revision

    FDA intends to interview blood donors to collect risk factor 
information associated with testing positive for a 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 recently revised the currently approved collection instrument 
for the collection of information and have included recently issued 
Agency guidance. On April 2, 2020, FDA issued a revised guidance 
document entitled ``Revised Recommendations for Reducing the Risk of 
Human Immunodeficiency Virus Transmission by Blood and Blood Products; 
Guidance for Industry'' dated April 2020 (available at: https://www.fda.gov/media/92490/download), which changed the blood donor 
criterion for men who have sex with men (MSM) from a 12-month deferral 
to a 3-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 3-
month donor deferral for MSM. We also made a change to the Risk Factor 
Assessment interview questionnaire to keep the TTIMS interview relevant 
with the current deferral. 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

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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 factor information 
collected through interviews of blood donors 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 
refocused 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 January 8, 2020 (85 FR 922), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received two comments that were generally 
supportive of the collection. One comment also contained a specific 
suggestion that, in analyzing the data after it is collected, we 
utilize an ``underreporting correction factor'' identified by the 
commenter. The comment did not suggest that we make any changes to the 
Donor Risk Assessment Questionnaire or the information collection 
requirements. We appreciate the commenter's interest in the accuracy of 
the TTIMS and will consider the ``underreporting correction factor'' 
identified by the commenter when analyzing the data.
    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  0.5 (30 minutes)             300
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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.

    We have adjusted our burden estimate, which has resulted in a 
decrease to the currently approved burden. Based on experience with 
this survey, we decreased the average burden per response from 45 to 30 
minutes, resulting in a change from 450 to 300 total hours.

    Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15009 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P