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, 89949-89950 [2016-29814]

Download as PDF Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices fully implement the feed standards will vary among States. Dated: December 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–29839 Filed 12–12–16; 8:45 am] BILLING CODE 4164–01–P 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 InstituteSponsored Transfusion-Transmissible Infections Monitoring System—Risk Factor Elicitation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 oira_ submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed pmangrum on DSK3GDR082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 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 mid1980s; 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 TransfusionTransmitted 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 (https://www.fda.gov/downloads/ BiologicsBloodVaccines/Guidance PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 89949 ComplianceRegulatoryInformation/ 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 E:\FR\FM\13DEN1.SGM 13DEN1 89950 Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 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 Number of responses per respondent Number of respondents Questionnaire/survey Cases and controls 2 ......................... 600 Total annual responses 1 600 Average burden per response 0.75 (45 minutes) ............................. Total hours 450 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. Electronic Submissions [FR Doc. 2016–29814 Filed 12–12–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0508] Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishment; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.’’ This guidance is intended to assist persons making tobacco product establishment pmangrum on DSK3GDR082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 15:08 Dec 12, 2016 Jkt 241001 comments, that information will be posted on https://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’’). Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 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 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– 2009–D–0508 for ‘‘Registration and Product Listing for Owners and Operators of Domestic Tobacco Product registration and product listing submissions to FDA. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1

Agencies

[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89949-89950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29814]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 oira_submission@omb.eop.gov. 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, PRAStaff@fda.hhs.gov.

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 (https://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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     Questionnaire/survey          Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cases and controls \2\........             600               1             600  0.75 (45                     450
                                                                                 minutes).
----------------------------------------------------------------------------------------------------------------
\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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.