82_FR_19140 82 FR 19062 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion

82 FR 19062 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 78 (April 25, 2017)

Page Range19062-19063
FR Document2017-08306

The Food and Drug Administration (FDA or we) 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 (the PRA).

Federal Register, Volume 82 Issue 78 (Tuesday, April 25, 2017) 
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19062-19063]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0868]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry: Use of Serological Tests To Reduce the Risk of Transmission 
of Trypanosoma cruzi Infection in Whole Blood and Blood Components for 
Transfusion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 (the PRA).

DATES: Fax written comments on the collection of information by May 25, 
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 0910-0681. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

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.

Guidance for Industry: Use of Serological Tests To Reduce the Risk of 
Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood 
Components Intended for Transfusion

OMB Control Number 0910-0681--Extension

    The guidance document implements the donor screening 
recommendations for the FDA-approved serological test systems for the 
detection of antibodies to T. cruzi. The use of the donor screening 
tests are to reduce the risk of transmission of T. cruzi infection by 
detecting antibodies to T. cruzi in plasma and serum samples from 
individual human donors, including donors of Whole Blood and blood 
components intended for transfusion. The guidance recommends that 
establishments that manufacture Whole Blood and blood components 
intended for transfusion should notify consignees of all previously 
collected in-date blood and blood components to quarantine and return 
the blood components to establishments or to destroy them within 3 
calendar days after a donor tests repeatedly reactive by a licensed 
test for T. cruzi antibody. When establishments identify a donor who is 
repeatedly reactive by a licensed test for T. cruzi antibodies and for 
whom there is additional information indicating risk of T. cruzi 
infection, such as testing positive on a licensed supplemental test 
(when such test is available) or until such test is available, 
information that the donor or donor's mother resided in an area endemic 
for Chagas disease (Mexico, Central and South America) or as a result 
of other medical diagnostic testing of the donor indicating T. cruzi 
infection, we recommend that the establishment notify consignees of all 
previously distributed blood and blood components collected during the 
lookback period and, if blood and blood components were transfused, 
encourage consignees to notify the recipient's physician of record of a 
possible increased risk of T. cruzi infection.
    Respondents to this information collection are establishments that 
manufacture Whole Blood and blood components intended for transfusion. 
We believe that the information collection provisions in the guidance 
for establishments to notify consignees and for consignees to notify 
the recipient's physician of record in the guidance do not create a new 
burden for respondents and are part of usual and customary business 
practices. Since the end of January 2007, a number of blood centers 
representing a large proportion of U.S. blood collections have been 
testing donors using a licensed assay. We believe these establishments 
have already developed standard operating procedures for notifying 
consignees and for the consignees to notify the recipient's physician 
of record.
    The guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR 601.12 have been approved under OMB control number 0910-0338; 
the

[[Page 19063]]

collections of information in 21 CFR 606.100, 606.121, 606.122, 
606.160(b)(ix), 606.170(b), 610.40, and 630.40 have been approved under 
OMB control numbers 0910-0116 and 0910-0795; the collections of 
information in 21 CFR 606.171 have been approved under OMB control 
number 0910-0458.
    In the Federal Register of November 7, 2016 (81 FR 78170), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08306 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P

19062 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices purity and potency) beyond the DEPARTMENT OF HEALTH AND systems for the detection of antibodies manufacturer’s labeled expiration date HUMAN SERVICES to T. cruzi. The use of the donor so the replacement of stockpiled screening tests are to reduce the risk of product could be deferred. This Food and Drug Administration transmission of T. cruzi infection by document, once finalized, will provide [Docket No. FDA–2013–N–0868] detecting antibodies to T. cruzi in guidance to government stakeholders on plasma and serum samples from testing to extend the shelf life (i.e., Agency Information Collection individual human donors, including expiration date) under section 564A(b) Activities; Submission for Office of donors of Whole Blood and blood of the FD&C Act (21 U.S.C. 360bbb– Management and Budget Review; components intended for transfusion. Comment Request; Guidance for The guidance recommends that 3a(b)) of stockpiled doxycycline tablets Industry: Use of Serological Tests To establishments that manufacture Whole and capsules for public health Reduce the Risk of Transmission of Blood and blood components intended emergency preparedness and response for transfusion should notify consignees purposes for an anthrax emergency. Trypanosoma cruzi Infection in Whole Blood and Blood Components for of all previously collected in-date blood The draft guidance applies to both Transfusion and blood components to quarantine doxycycline monohydrate and and return the blood components to doxycycline hyclate tablets and AGENCY: Food and Drug Administration, establishments or to destroy them capsules equivalent to 50 mg and 100 HHS. within 3 calendar days after a donor mg of doxycycline that are indicated for ACTION: Notice. tests repeatedly reactive by a licensed PEP or treatment of inhalational test for T. cruzi antibody. When anthrax. Where doxycycline is SUMMARY: The Food and Drug establishments identify a donor who is Administration (FDA or we) is repeatedly reactive by a licensed test for mentioned throughout this guidance, it announcing that a proposed collection T. cruzi antibodies and for whom there is meant to include both the hyclate and of information has been submitted to the is additional information indicating risk monohydrate forms of the drug that are Office of Management and Budget of T. cruzi infection, such as testing indicated for PEP or treatment of (OMB) for review and clearance under positive on a licensed supplemental test inhalational anthrax. the Paperwork Reduction Act of 1995 (when such test is available) or until This draft guidance is being issued (the PRA). such test is available, information that consistent with FDA’s good guidance DATES: Fax written comments on the the donor or donor’s mother resided in practices regulation (21 CFR 10.115). collection of information by May 25, an area endemic for Chagas disease The draft guidance, when finalized, will 2017. (Mexico, Central and South America) or represent the current thinking of FDA as a result of other medical diagnostic ADDRESSES: To ensure that comments on on ‘‘Extending Expiration Dates of testing of the donor indicating T. cruzi the information collection are received, Doxycycline Tablets and Capsules in infection, we recommend that the OMB recommends that written Strategic Stockpiles.’’ It does not establishment notify consignees of all comments be faxed to the Office of establish any rights for any person and previously distributed blood and blood Information and Regulatory Affairs, is not binding on FDA or the public. components collected during the OMB, Attn: FDA Desk Officer, FAX: You can use an alternative approach if lookback period and, if blood and blood 202–395–7285, or emailed to oira_ it satisfies the requirements of the components were transfused, encourage submission@omb.eop.gov. All consignees to notify the recipient’s applicable statutes and regulations. comments should be identified with the physician of record of a possible OMB control number 0910–0681. Also increased risk of T. cruzi infection. II. Paperwork Reduction Act of 1995 include the FDA docket number found Respondents to this information This guidance refers to previously in brackets in the heading of this collection are establishments that approved collections of information that document. manufacture Whole Blood and blood are subject to review by the Office of FOR FURTHER INFORMATION CONTACT: components intended for transfusion. Management and Budget (OMB) under JonnaLynn Capezzuto, Office of We believe that the information the Paperwork Reduction Act of 1995 Operations, Food and Drug collection provisions in the guidance for (44 U.S.C. 3501–3520). The collection of Administration, Three White Flint establishments to notify consignees and information has been approved under North, 10A63, 11601 Landsdown St., for consignees to notify the recipient’s OMB control number 0910–0595. North Bethesda, MD 20852, 301–796– physician of record in the guidance do 3794. not create a new burden for respondents III. Electronic Access and are part of usual and customary SUPPLEMENTARY INFORMATION: In business practices. Since the end of Persons with access to the Internet compliance with 44 U.S.C. 3507, FDA January 2007, a number of blood centers may obtain the draft guidance at either has submitted the following proposed representing a large proportion of U.S. http://www.fda.gov/Drugs/Guidance collection of information to OMB for blood collections have been testing ComplianceRegulatoryInformation/ review and clearance. donors using a licensed assay. We Guidances/default.htm or https:// Guidance for Industry: Use of believe these establishments have www.regulations.gov. Serological Tests To Reduce the Risk of already developed standard operating asabaliauskas on DSK3SPTVN1PROD with NOTICES Dated: April 19, 2017. Transmission of Trypanosoma cruzi procedures for notifying consignees and Anna K. Abram, Infection in Whole Blood and Blood for the consignees to notify the Components Intended for Transfusion recipient’s physician of record. Deputy Commissioner for Policy, Planning, The guidance also refers to previously Legislation, and Analysis. OMB Control Number 0910–0681— approved collections of information [FR Doc. 2017–08326 Filed 4–24–17; 8:45 am] Extension found in FDA regulations. The BILLING CODE 4164–01–P The guidance document implements collections of information in 21 CFR the donor screening recommendations 601.12 have been approved under OMB for the FDA-approved serological test control number 0910–0338; the VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1

Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices 19063 collections of information in 21 CFR Avenue, Bldg. 51, Rm. 6314, Silver III. Participating in the Public 606.100, 606.121, 606.122, Spring, MD 20993, 301–796–7578, Workshop 606.160(b)(ix), 606.170(b), 610.40, and Kayla.Garvin@fda.hhs.gov. Registration: To register for the public 630.40 have been approved under OMB SUPPLEMENTARY INFORMATION: workshop, please visit the following control numbers 0910–0116 and 0910– Web site: https://www.eventbrite.com/e/ 0795; the collections of information in I. Background sentinel-training-at-food-and-drug- 21 CFR 606.171 have been approved The Sentinel Initiative began in 2008 administration-registration- under OMB control number 0910–0458. as a multiyear effort to create a national 32503315291. Please provide required In the Federal Register of November electronic system for monitoring the contact information for each attendee, 7, 2016 (81 FR 78170), we published a performance of FDA-regulated medical including name, title, affiliation, and 60-day notice requesting public products. The Sentinel Initiative is email. comment on the proposed extension of FDA’s response to the Food and Drug Registration is free and based on this collection of information. No Administration Amendments Act of space availability, with priority given to comments were received in response to 2007 (FDAAA) requirement that FDA early registrants. Early registration is the notice. work with public, academic, and private recommended because seating is Dated: April 18, 2017. entities to develop a system to obtain limited; therefore, FDA may limit the Anna K. Abram, information from existing electronic number of participants from each Deputy Commissioner for Policy, Planning, health care data from multiple sources organization. If time and space permit, Legislation, and Analysis. to assess the safety of FDA approved onsite registration on the day of the [FR Doc. 2017–08306 Filed 4–24–17; 8:45 am] medical products. public workshop will be provided BILLING CODE 4164–01–P The Sentinel System uses a beginning at 9 a.m. distributed data approach in which Data If you need special accommodations Partners maintain physical and due to a disability, please contact Kayla DEPARTMENT OF HEALTH AND operational control over electronic Garvin no later than June 30, 2017. HUMAN SERVICES health care data in their existing Streaming Webcast of the public environments. The distributed approach workshop: This public workshop will Food and Drug Administration is achieved by using a standardized data also be Webcast at: https:// [Docket No. FDA–2017–N–0001] structure referred to as the Sentinel collaboration.fda.gov/ Common Data Model. Data Partners sentineltraining2017/. Sentinel Training at the Food and Drug transform their data locally in If you have never attended a Connect Administration; Public Workshop accordance with the Common Data Pro event before, test your connection at Model, which enables them to execute https://collaboration.fda.gov/common/ AGENCY: Food and Drug Administration, standardized computer programs that help/en/support/meeting_test.htm. To HHS. run identically at each Data Partner site. get a quick overview of the Connect Pro ACTION: Notice of public workshop. Data Partners are able to review the program, visit https://www.adobe.com/ SUMMARY: The Food and Drug results of the queries before sending go/connectpro_overview. FDA has Administration (FDA, the Agency, or them back to the Sentinel Operations verified the Web site addresses in this we) is announcing the following public Center. Queries are distributed and document, as of the date this document workshop entitled ‘‘Sentinel Training at results are returned through a secure publishes in the Federal Register, but FDA.’’ The purpose of the public portal to preserve privacy. Web sites are subject to change over workshop is to provide training to II. Topics for Discussion at the Public time. understand the kinds of questions that Workshop Transcripts: Please be advised that can be asked using health care claims transcripts will not be available. data generally and within the FDA This full-day seminar, targeting Dated: April 19, 2017. Sentinel System specifically, allowing clinical researchers and others without Leslie Kux, an understanding of the capabilities of direct experience using health care claims data, will provide an overview of Associate Commissioner for Policy. the Sentinel System. [FR Doc. 2017–08302 Filed 4–24–17; 8:45 am] data that are and are not available in the DATES: The public workshop will be Sentinel Distributed Database, the BILLING CODE 4164–01–P held on July 10, 2017, from 10 a.m. to Sentinel Common Data Model, and a 4 p.m. description of the distributed tools ADDRESSES: The public workshop will available to work with the data. This DEPARTMENT OF HEALTH AND be held at FDA’s White Oak Campus, seminar will help those in attendance HUMAN SERVICES 10903 New Hampshire Ave., Bldg. 31, understand the kinds of questions that Rm. 1503 (the Great Room), Silver Food and Drug Administration can be asked using health care claims Spring, MD 20993. Entrance for the data generally and within the Sentinel [Docket No. FDA–2013–N–1393] public workshop participants (non-FDA System specifically. Attendees will employees) is through Building 1 where leave with an understanding of the Agency Information Collection routine security check procedures will capabilities of the Sentinel System. The Activities; Submission for Office of be performed. For parking and security Sentinel System can help the public, Management and Budget Review; asabaliauskas on DSK3SPTVN1PROD with NOTICES information, please refer to https:// academia, and private entities better Comment Request; Patent Term www.fda.gov/AboutFDA/ understand potential safety issues Restoration, Due Diligence Petitions, WorkingatFDA/BuildingsandFacilities/ associated with FDA-approved medical Filing, Format, and Content of WhiteOakCampusInformation/ products. Importantly, users can get Petitions ucm241740.htm. responses to their questions in a matter AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: of weeks, as compared to months, or HHS. Kayla Garvin, Food and Drug even longer using traditional ACTION: Notice. Administration, 10903 New Hampshire surveillance methods. VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\25APN1.SGM 25APN1


Document Created: 2017-04-25 02:18:54
Document Modified: 2017-04-25 02:18:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by May 25, 2017.
ContactJonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
FR Citation82 FR 19062 
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