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)
Food and Drug Administration
Federal Register Volume 81, Issue 190 (September 30, 2016)
| Page Range | 67358-67360 | |
| FR Document | 2016-23622 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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, PRAStaff@fda.hhs.gov. 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Questionnaire/survey Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Cases and controls.\2\.......................... 600 1 600 0.75 (45 minutes)................. 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: 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
![67358 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices
tropical disease priority review user fee User Fees Payment Portal at https:// 1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
amount for FY 2017 that must be userfees.fda.gov/pay. Once you search ‘‘Developing Drugs for Developing
submitted with a priority review for your invoice, click ‘‘Pay Now’’ to be Countries,’’ Health Affairs, vol. 25, no. 2,
pp. 313–324, 2006.
voucher for a human drug application in redirected to Pay.gov. Note that
FY 2017, in addition to any PDUFA fee electronic payment options are based on Dated: September 26, 2016.
that is required for such an application. the balance due. Payments must be Leslie Kux,
drawn on U.S bank accounts. Associate Commissioner for Policy.
III. Fee Schedule for FY 2017 FDA has partnered with the U.S. [FR Doc. 2016–23623 Filed 9–29–16; 8:45 am]
The fee rate for FY 2017 is set out in Department of the Treasury to use BILLING CODE 4164–01–P
Table 1: Pay.gov, a Web-based payment
application, for online electronic
TABLE 1—TROPICAL DISEASE PRI- payment. The Pay.gov feature is DEPARTMENT OF HEALTH AND
ORITY REVIEW SCHEDULE FOR FY available on the FDA Web site after the HUMAN SERVICES
2017 user fee ID number is generated.
The user fee identification (ID) Food and Drug Administration
Fee rate for number should be included on the
Fee category [Docket No. FDA–2016–N–2836]
FY 2017 check, followed by the words ‘‘Tropical
Disease Priority Review.’’ Payments can Agency Information Collection
Application submitted with a be mailed to: Food and Drug
tropical disease priority re- Activities; Proposed Collection;
view voucher in addition to
Administration, P.O. Box 979107, St. Comment Request; Donor Risk
the normal PDUFA fee ..... $2,706,000 Louis, MO 63197–9000. Assessment Questionnaire for the
If checks are sent by a courier that Food and Drug Administration/National
requests a street address, the courier can Heart, Lung, and Blood Institute-
IV. Implementation of Tropical Disease
deliver the checks to: U.S. Bank, Sponsored Transfusion-Transmissible
Priority Review User Fee
Attention: Government Lockbox 979107, Infections Monitoring System—Risk
Under section 524(c)(4)(A) of the 1005 Convention Plaza, St. Louis, MO
FD&C Act, the priority review user fee Factor Elicitation
63101. (Note: This U.S. Bank address is
is due upon submission of a human for courier delivery only. If you have AGENCY: Food and Drug Administration,
drug application for which the priority any questions concerning courier HHS.
review voucher is used. Section delivery contact the U.S. Bank at 314– ACTION: Notice.
524(c)(4)(B) of the FD&C Act specifies 418–4013. This telephone number is
that the application will be considered only for questions about courier SUMMARY: The Food and Drug
incomplete if the priority review user delivery.) The FDA post office box Administration (FDA) is announcing an
fee and all other applicable user fees are number (P.O. Box 979107) must be opportunity for public comment on the
not paid in accordance with FDA written on the check. The tax proposed collection of certain
payment procedures. In addition, FDA identification number of FDA is 53– information by the Agency. Under the
may not grant a waiver, exemption, 0196965. Paperwork Reduction Act of 1995 (the
reduction, or refund of any fees due and If paying by wire transfer, please PRA), Federal Agencies are required to
payable under this section of the FD&C reference your unique user fee ID publish notice in the Federal Register
Act and FDA may not collect priority number when completing your transfer. concerning each proposed collection of
review voucher fees ‘‘except to the The originating financial institution information and to allow 60 days for
extent provided in advance in may charge a wire transfer fee. Please public comment in response to the
appropriation Acts.’’ Section ask your financial institution about the notice. This notice solicits comments on
524(c)(4)(C) and 524(c)(5)(B). Beginning fee and include it with your payment to an information collection request
with FDA’s appropriation for FY 2009, ensure that your fee is fully paid. The regarding risk factors associated with
the annual appropriation language states account information is as follows: U.S. transfusion-transmissible infections
specifically that ‘‘priority review user Dept. of Treasury, TREAS NYC, 33 (TTI) in blood donors.
fees authorized by 21 U.S.C. 360n Liberty St., New York, NY 10045, DATES: Submit either electronic or
(section 524 of the FD&C Act) may be Account Number: 75060099, Routing written comments on the collection of
credited to this account, to remain Number: 021030004, SWIFT: information by November 29, 2016.
available until expended.’’ (Pub. L. 111– FRNYUS33, Beneficiary: FDA, 8455 ADDRESSES: You may submit comments
8, Section 5, Division A, Title VI). Colesville Rd., 14th Floor, Silver Spring, as follows:
The tropical disease priority review MD 20993–0002.
fee established in the new fee schedule Paying by credit card (Discover, VISA, Electronic Submissions
must be paid for any application that is MasterCard, American Express) is Submit electronic comments in the
received on or after October 1, 2016, and available for balances less than $25,000. following way:
submitted with a priority review If the balance exceeds this amount, only • Federal eRulemaking Portal: http://
voucher. This fee must be paid in the ACH option is available. Payments www.regulations.gov. Follow the
addition to any other fee due under must be drawn on U.S. credit cards. instructions for submitting comments.
PDUFA. Payment must be made in U.S. Comments submitted electronically,
currency by electronic check, check, V. Reference including attachments, to http://
bank draft, wire transfer, credit card, or The following reference is on display www.regulations.gov will be posted to
mstockstill on DSK3G9T082PROD with NOTICES
U.S. postal money order payable to the in the Division of Dockets Management the docket unchanged. Because your
order of the Food and Drug (HFA–305), Food and Drug comment will be made public, you are
Administration. The preferred payment Administration, 5630 Fishers Lane, Rm. solely responsible for ensuring that your
method is online using electronic check 1061, Rockville, MD 20852, and is comment does not include any
(Automated Clearing House (ACH) also available for viewing by interested confidential information that you or a
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payments can be submitted using the Monday through Friday. such as medical information, your or
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![67360 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices
FDA issued a document entitled donors. These data also will inform FDA the TTIMS program will maintain
‘‘Revised Recommendations for regarding future blood donor deferral standardized, statistically and
Reducing the Risk of Human policy options to reduce the risk of HIV scientifically robust processes for
Immunodeficiency Virus Transmission transmission, including the feasibility of applying hemovigilance information
by Blood and Blood Products, Guidance moving from the existing time-based across blood collection organizations.
for Industry’’ dated December 2015 deferrals related to risk behaviors to The specific objectives are to:
(http://www.fda.gov/downloads/ alternate deferral options, such as the • Determine current behavioral risk
BiologicsBloodVaccines/Guidance use of individual risk assessments, and factors associated with all HIV
ComplianceRegulatoryInformation/ to inform the design of potential studies infections, incident HBV, and incident
Guidances/Blood/UCM446580.pdf) to evaluate the feasibility and HCV infections in blood donors
which changed the blood donor effectiveness of such alternative deferral (including parenteral and sexual risks)
criterion for men who have sex with options. across the participating blood collection
men (MSM) from an indefinite TTIMS will include a comprehensive organizations using a case-control study
(permanent) deferral to a 12-month interview-based epidemiological study design.
deferral since last MSM contact. The of risk factor information for viral • Determine infectious disease
impact of this change in the deferral infection-positive blood donors at the marker prevalence and incidence for
criteria requires a national monitoring American Red Cross (ARC), Blood HIV, HBV, and HCV overall and by
effort as part of TTIMS to assess if the Systems, Inc. (BSI), New York Blood demographic characteristics of donors
relative proportions of risk factors for Center (NYBC), and OneBlood that will in the majority of blood donations
infection in blood donors have changed identify the current predominant risk collected in the country. This will be
following the adoption of the 12-month factors and reasons for virus-positive accomplished by forming
donor deferral for MSM. TTIMS will use donations. The TTIMS program epidemiological databases consisting of
similar procedures as the ones used in establishes a new, ongoing donor harmonized operational data from ARC,
the REDS–II study to monitor and hemovigilance capacity that currently BSI, NYBC, and OneBlood.
evaluate risk factors among HIV-positive does not exist in the United States. • Analyze integrated risk factor and
donors and recently HCV or HBV Using procedures developed by the infectious marker testing data
infected donors as well as controls. REDS–II study, TTIMS will establish concurrently because when taken
This study will help identify the this capacity in greater than 50 percent together these may suggest that blood
specific risk factors for TTI and their of all blood donations collected in the centers are not achieving the same
prevalence in blood donors, and help country. degree of success in educational efforts
inform FDA on the proportion of As part of the TTIMS project, a to prevent donation by donors with risk
incident (new) infections among all HIV comprehensive hemovigilance database behaviors across all demographic
positive blood donors. Donations with will be created that integrates the risk groups.
incident infections have the greatest factor information collected through The respondents will be persons who
potential transmission risk because they donor interviews of blood donor with donated blood in the United States and
could be missed during routine blood the resulting data from disease marker these participants will be defined as
screening. The study will help FDA testing and blood components collected cases and controls. The estimated
evaluate the effectiveness of screening by participating organizations into a number of respondents is based on an
strategies in reducing the risk of HIV research database. Following successful overall expected participation in the
transmission from at-risk donors and to initiation of the risk factor interviews, risk factor survey. We estimate a case to
evaluate if there are unexpected the TTIMS network is poised to be control ratio of 1:2 (200 to 400) with a
consequences associated with the recent expanded to include additional blood 50 percent case enrollment.
change in donor deferral policy such as centers and/or re-focused on other FDA estimates the burden of this
an increase in HIV incidence among safety threats as warranted. In this way, collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden Total
Questionnaire/survey responses per
respondents responses per response hours
respondent
Cases and controls.2 ............................................ 600 1 600 0.75 (45 minutes) .......... 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: September 26, 2016. DEPARTMENT OF HEALTH AND ACTION: Notice.
Leslie Kux, HUMAN SERVICES
Associate Commissioner for Policy. SUMMARY: The Food and Drug
[FR Doc. 2016–23622 Filed 9–29–16; 8:45 am] Food and Drug Administration Administration (FDA or the Agency) is
BILLING CODE 4164–01–P
announcing the fee rate for using a rare
pediatric disease priority review
mstockstill on DSK3G9T082PROD with NOTICES
[Docket No. FDA–2016–N–0007]
voucher for fiscal year (FY) 2017. The
Fee for Using a Rare Pediatric Disease Federal Food, Drug, and Cosmetic Act
Priority Review Voucher in Fiscal Year (the FD&C Act), as amended by the Food
2017 and Drug Administration Safety and
Innovation Act (FDASIA), authorizes
AGENCY: Food and Drug Administration, FDA to determine and collect rare
HHS. pediatric disease priority review user
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Document Created: 2018-02-09 13:33:48
Document Modified: 2018-02-09 13:33:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by November 29, 2016. | |
| 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] | |
| FR Citation | 81 FR 67358 |
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