81 FR 78170 - Agency Information Collection Activities; Proposed Collection; 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 Intended for Transfusion
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 215 (November 7, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 215 (November 7, 2016)
| Page Range | 78170-78172 | |
| FR Document | 2016-26792 |
[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)] [Notices] [Pages 78170-78172] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-26792] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0868] Agency Information Collection Activities; Proposed Collection; 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 Intended for Transfusion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on establishing notification of a consignee and consignee notification of a recipient's [[Page 78171]] physician of record regarding a possible increased risk of Trypanosoma cruzi (T. cruzi) infection. DATES: Submit either electronic or written comments on the collection of information by January 6, 2017. 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 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-2013-N-0868 for ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of the Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion.'' 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, including each proposed extension of an existing 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. 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 purpose of the donor screening tests is 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 and positive on a licensed [[Page 78172]] supplemental test, 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 collections of information in 21 CFR 606.100, 606.121, 606.122, 606.160(b)(ix), 606.170(b), 610.40, and 630.6 have been approved under OMB control number 0910-0116; the collections of information in 21 CFR 606.171 have been approved under OMB control number 0910-0458. Dated: November 1, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-26792 Filed 11-4-16; 8:45 am] BILLING CODE 4164-01-P
![78170 Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
information marked as ‘‘confidential’’ partners’ experiences regarding specific partners view especially positively and/
will not be disclosed except in disease states and/or medical devices or negatively?
accordance with 21 CFR 10.20 and other used for the patient’s treatment, • What methods or qualities of
applicable disclosure law. For more diagnosis, or assessment. It will not communication might be preferred or
information about FDA’s posting of solicit or provide external policy advice convenient for patients and care-
comments to public dockets, see 80 FR or opinion. partners?
56469, September 18, 2015, or access Additionally, P&CC will provide an III. Reference
the information at: http://www.fda.gov/ avenue for designated groups of patients
regulatoryinformation/dockets/ and care-partners to address specific The following reference is on display
default.htm. questions pertinent to their treatment, in the Division of Dockets Management
Docket: For access to the docket to diagnosis, or assessment by partnering (see ADDRESSES) and is available for
read background documents or the with patient organizations in an effort to viewing by interested persons between
electronic and written/paper comments connect their members with CDRH staff, 9 a.m. and 4 p.m., Monday through
received, go to http:// when the need for input arises. Patient Friday; it is also available electronically
www.regulations.gov and insert the organizations shall be 501(c)(3) at http://www.regulations.gov. FDA has
docket number, found in brackets in the organizations that have infrastructure verified the Web site address, as of the
heading of this document, into the conducive to soliciting patient and date this document publishes in the
‘‘Search’’ box and follow the prompts caregiver participation, and whose Federal Register, but Web sites are
and/or go to the Division of Dockets membership possesses relevant subject to change over time.
Management, 5630 Fishers Lane, Rm. experience. Topics will be highly 1. FDA, Center for Devices and Radiological
1061, Rockville, MD 20852. focused and restricted to specified Health, ‘‘2016–2017 Strategic Priorities,’’
FOR FURTHER INFORMATION CONTACT: disease states and/or medical devices. available at http://www.fda.gov/
Patients and care-partners will downloads/AboutFDA/CentersOffices/
Anne Hammer, Center for Devices and
participate in P&CC on a gratuitous OfficeofMedicalProductsandTobacco/
Radiological Health, Food and Drug CDRH/CDRHVisionandMission/
Administration, 10903 New Hampshire basis. Patients and care-partners will UCM481588.pdf.
Ave., Bldg. 66, Rm. 5400, Silver Spring, also report any conflict of interests they
may have that are pertinent to the Dated: October 31, 2016.
MD 20993, 301–796–4642, FAX: 301–
847–8510, anne.hammer@fda.hhs.gov. discussion, although conflicts of interest Leslie Kux,
may not disqualify a patient or care- Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
partner from participating in P&CC. [FR Doc. 2016–26784 Filed 11–4–16; 8:45 am]
I. Background BILLING CODE 4164–01–P
II. Patient and Care-Partner Connection
One of the three CDRH 2016–2017 Program
Strategic Priorities is to ‘‘Partner with
Patients’’ 1 (Ref. 1). This priority reflects The Agency is seeking comments DEPARTMENT OF HEALTH AND
and builds on our strong commitment to from interested persons on P&CC in HUMAN SERVICES
patients, who are our most important general, and on the following questions:
customers. CDRH believes that to Food and Drug Administration
General
successfully achieve this mission, we [Docket No. FDA–2013–N–0868]
must consider and engage with patients • What are potential barriers to
as partners. With regard to this priority, inclusion for patients and care-partners? Agency Information Collection
• What can FDA do to avoid or Activities; Proposed Collection;
CDRH also understands that family or
remedy any barriers to inclusion? Comment Request; Guidance for
care-partners are integral to patient care
• What might patients and care- Industry: Use of Serological Tests To
and management of disease, and we are
partners see as appropriate and effective Reduce the Risk of Transmission of
also committed to engaging them in
engagement with FDA? Trypanosoma cruzi Infection in Whole
order to fulfill this mission. FDA will
• How appropriate is the program Blood and Blood Components
work with both groups to advance the
title, ‘‘Patient and Care-partner Intended for Transfusion
development and evaluation of
Connection’’?
innovative medical devices and to • What, if any, other titles should AGENCY: Food and Drug Administration,
monitor the performance of marketed FDA consider? HHS.
devices. In addition, partnerships will
ACTION: Notice.
be leveraged, by promoting a culture of Inclusion
meaningful patient engagement and • What types of organizations are SUMMARY: The Food and Drug
interaction between CDRH staff and appropriate for such a partnership? Administration (FDA or we) is
patients and care-partners. • What are potential barriers to announcing an opportunity for public
To achieve this goal, FDA intends to effective communication between FDA, comment on the proposed collection of
establish a new program, called the partner organizations, patients, and certain information by the Agency.
Patient and Care-partner Connection care-partners? Under the Paperwork Reduction Act of
(P&CC). This program is designed to • How can FDA engage patients, 1995 (the PRA), Federal Agencies are
provide CDRH staff with a formal especially those who are hard to reach required to publish notice in the
process by which they can engage with or from underserved communities who Federal Register concerning each
patients and care-partners to obtain proposed collection of information,
sradovich on DSK3GMQ082PROD with NOTICES
are typically underrepresented in such
input on key issues. P&CC will broaden initiatives? including each proposed extension of an
CDRH’s exposure to patients’ and care- existing collection of information, and
Communication to allow 60 days for public comment in
1 CDRH’s 2016–2017 Strategic Priorities, in • What lines of questioning would be response to the notice. This notice
addition to ‘‘partner[ing] with patients,’’ include
‘‘Establish a National Evaluation System for
considered appropriate? solicits comments on establishing
Medical Devices’’ and ‘‘Promote a Culture of • What characteristics of such a notification of a consignee and
Quality and Organizational Excellence.’’ program might patients and care- consignee notification of a recipient’s
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![78172 Federal Register / Vol. 81, No. 215 / Monday, November 7, 2016 / Notices
supplemental test, we recommend that the discussions could disclose as amended. The grant applications and
the establishment notify consignees of confidential trade secrets or commercial the discussions could disclose
all previously distributed blood and property such as patentable material, confidential trade secrets or commercial
blood components collected during the and personal information concerning property such as patentable material,
lookback period and, if blood and blood individuals associated with the grant and personal information concerning
components were transfused, encourage applications, the disclosure of which individuals associated with the grant
consignees to notify the recipient’s would constitute a clearly unwarranted applications, the disclosure of which
physician of record of a possible invasion of personal privacy. would constitute a clearly unwarranted
increased risk of T. cruzi infection. Name of Committee: National Institute of invasion of personal privacy.
Respondents to this information Allergy and Infectious Diseases Special Name of Committee: National Institute of
collection are establishments that Emphasis Panel; Human Tissue Models For Environmental Health Sciences Special
manufacture Whole Blood and blood Infectious Diseases (U19). Emphasis Panel; Research Opportunities in
components intended for transfusion. Date: December 1–2, 2016. Environmental Health Sciences (R21).
We believe that the information Time: 8:00 a.m. to 5:30 p.m. Date: November 21, 2016.
collection provisions in the guidance for Agenda: To review and evaluate grant Time: 10:00 a.m. to 12:00 p.m.
establishments to notify consignees and applications. Agenda: To review and evaluate grant
Place: The William F. Bolger Center, applications.
for consignees to notify the recipient’s Stained Glass Hall, 9600 Newbridge Drive, Place: NIEHS/National Institutes of Health,
physician of record in the guidance do Potomac, MD 20854. Keystone Building, Room 3118, 79 T.W.
not create a new burden for respondents Contact Person: Brenda Lange-Gustafson, Alexander Drive, Research Triangle Park, NC
and are part of usual and customary Ph.D., Scientific Review Officer, Scientific 27709, (Telephone Conference Call).
business practices. Since the end of Review Program, Division of Extramural Contact Person: RoseAnne M. McGee,
January 2007, a number of blood centers Activities, Room # 3G41B National Institutes Scientific Review Officer, Scientific Review
representing a large proportion of U.S. of Health/NIAID, 5601 Fishers Lane, MSC Branch, Division of Extramural Research and
blood collections have been testing 9823, Bethesda, MD 20892–9823, (240) 669– Training, Nat. Institute of Environmental
5047, bgustafson@niaid.nih.gov. Health Sciences, P.O. Box 12233, MD EC–30,
donors using a licensed assay. We Research Triangle Park, NC 27709, (919) 541–
believe these establishments have Name of Committee: National Institute of
Allergy and Infectious Diseases Special 0752, mcgee1@niehs.nih.gov.
already developed standard operating (Catalogue of Federal Domestic Assistance
Emphasis Panel; NIAID Clinical Trial
procedures for notifying consignees and Implementation Grant (R01). Program Nos. 93.115, Biometry and Risk
for the consignees to notify the Date: December 16, 2016. Estimation—Health Risks from
recipient’s physician of record. Time: 1:00 p.m. to 3:00 p.m. Environmental Exposures; 93.142, NIEHS
The guidance also refers to previously Agenda: To review and evaluate grant Hazardous Waste Worker Health and Safety
approved collections of information applications. Training; 93.143, NIEHS Superfund
found in FDA regulations. The Place: National Institutes of Health, 5601 Hazardous Substances—Basic Research and
Fishers Lane, Rockville, MD 20892, Education; 93.894, Resources and Manpower
collections of information in 21 CFR
(Telephone Conference Call). Development in the Environmental Health
601.12 have been approved under OMB Sciences; 93.113, Biological Response to
control number 0910–0338; the Contact Person: Chelsea D. Boyd, Scientific
Review Officer, Scientific Review Program, Environmental Health Hazards; 93.114,
collections of information in 21 CFR Applied Toxicological Research and Testing,
DEA/NIAID/NIH/DHHS, 5601 Fishers Lane,
606.100, 606.121, 606.122, MSC–9823, Rockville, MD 20852–9834, 240– National Institutes of Health, HHS)
606.160(b)(ix), 606.170(b), 610.40, and 669–2081, chelsea.boyd@nih.gov. Dated: November 1, 2016.
630.6 have been approved under OMB (Catalogue of Federal Domestic Assistance Michelle Trout,
control number 0910–0116; the Program Nos. 93.855, Allergy, Immunology, Program Analyst, Office of Federal Advisory
collections of information in 21 CFR and Transplantation Research; 93.856, Committee Policy.
606.171 have been approved under Microbiology and Infectious Diseases
[FR Doc. 2016–26767 Filed 11–4–16; 8:45 am]
OMB control number 0910–0458. Research, National Institutes of Health, HHS)
BILLING CODE 4140–01–P
Dated: November 1, 2016. Dated: November 1, 2016.
Leslie Kux, Natasha M. Copeland,
Associate Commissioner for Policy. Program Analyst, Office of Federal Advisory DEPARTMENT OF HEALTH AND
[FR Doc. 2016–26792 Filed 11–4–16; 8:45 am] Committee Policy. HUMAN SERVICES
BILLING CODE 4164–01–P [FR Doc. 2016–26772 Filed 11–4–16; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND Center for Scientific Review; Notice of
HUMAN SERVICES DEPARTMENT OF HEALTH AND Closed Meetings
HUMAN SERVICES Pursuant to section 10(d) of the
National Institutes of Health Federal Advisory Committee Act, as
National Institutes of Health amended (5 U.S.C. App.), notice is
National Institute of Allergy and
hereby given of the following meetings.
Infectious Diseases; Notice of Closed National Institute of Environmental The meetings will be closed to the
Meetings Health Sciences; Notice of Closed public in accordance with the
Meeting provisions set forth in sections
Pursuant to section 10(d) of the
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
sradovich on DSK3GMQ082PROD with NOTICES
Federal Advisory Committee Act, as Pursuant to section 10(d) of the
amended (5 U.S.C. App.), notice is Federal Advisory Committee Act, as as amended. The grant applications and
hereby given of the following meetings. amended (5 U.S.C. App.), notice is the discussions could disclose
The meetings will be closed to the hereby given of the following meeting. confidential trade secrets or commercial
public in accordance with the The meeting will be closed to the property such as patentable material,
provisions set forth in sections public in accordance with the and personal information concerning
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., provisions set forth in sections individuals associated with the grant
as amended. The grant applications and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., applications, the disclosure of which
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Document Created: 2018-02-14 08:21:56
Document Modified: 2018-02-14 08:21:56
| 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 January 6, 2017. | |
| 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 78170 |
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