81 FR 67358 - Agency Information Collection Activities; Proposed Collection; 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 190 (September 30, 2016)

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 on an information collection request regarding risk factors associated with transfusion-transmissible infections (TTI) in blood donors.

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67358-67360]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 on an information collection request regarding 
risk factors associated with transfusion-transmissible infections (TTI) 
in blood donors.

DATES: Submit either electronic or written comments on the collection 
of information by November 29, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or

[[Page 67359]]

anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2836 for ``Donor Risk Assessment Questionnaire for the Food 
and Drug Administration (FDA)/National Heart, Lung, and Blood Institute 
(NHLBI)-sponsored Transfusion-Transmissible Infections Monitoring 
System (TTIMS)--Risk Factor Elicitation (RFE).'' 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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Donor Risk Assessment Questionnaire for the Food and Drug 
Administration (FDA)/National Heart, Lung, and Blood Institute (NHLBI)-
Sponsored Transfusion-Transmissible Infections Monitoring System 
(TTIMS)--Risk Factor Elicitation (RFE) OMB Control Number--New

    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 United States 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.

[[Page 67360]]

    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) 
which 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 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.
    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 per response       Total hours
                                                    respondents       respondent       responses
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Cases and controls.\2\..........................             600                1              600   0.75 (45 minutes).................             450
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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: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23622 Filed 9-29-16; 8:45 am]
BILLING CODE 4164-01-P