Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, To Reduce the Risk of Transmission of Hepatitis B Virus; Availability, 68133-68134 [2012-27783]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 221 / Thursday, November 15, 2012 / Notices
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
[FR Doc. 2012–27724 Filed 11–14–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0799]
Guidance for Industry: Use of Nucleic
Acid Tests on Pooled and Individual
Samples From Donors of Whole Blood
and Blood Components, Including
Source Plasma, To Reduce the Risk of
Transmission of Hepatitis B Virus;
Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Use of Nucleic
Acid Tests on Pooled and Individual
Samples from Donors of Whole Blood
and Blood Components, including
Source Plasma, to Reduce the Risk of
Transmission of Hepatitis B Virus,’’
dated October 2012. The guidance
document provides recommendations
on the use of FDA-licensed nucleic acid
tests (NAT) to screen blood donors for
hepatitis B virus (HBV)
deoxyribonucleic acid (DNA) and
recommendations for product testing
and disposition, donor management,
methods for donor requalification, and
product labeling. In addition, the
guidance provides notification that FDA
considers the use of an FDA-licensed
HBV NAT to be necessary to reduce
adequately and appropriately the risk of
transmission of HBV. The guidance is
intended for blood establishments that
collect Whole Blood and blood
components for transfusion or for
further manufacture, including
recovered plasma, Source Plasma and
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:22 Nov 14, 2012
Jkt 229001
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
E. Levine, Jr., Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
DATES:
Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Source Leukocytes. The guidance
announced in this notice finalizes the
draft guidance of the same title, dated
November 2011. The guidance also
supplements previous memoranda and
guidance from FDA concerning the
testing of donations for hepatitis B
surface antigen (HBsAg) and antibody to
hepatitis B core antigen (anti-HBc) and
the management of donors and
donations mentioned in those
documents.
I. Background
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Use of Nucleic Acid Tests on
Pooled and Individual Samples from
Donors of Whole Blood and Blood
Components, including Source Plasma,
to Reduce the Risk of Transmission of
Hepatitis B Virus,’’ dated October 2012.
FDA is providing blood establishments
that collect Whole Blood and blood
components for transfusion or for
further manufacture, including
recovered plasma, Source Plasma and
Source Leukocytes, with
recommendations concerning the use of
FDA-licensed NAT to screen blood
donors for HBV DNA. FDA is also
providing these blood establishments
with recommendations for product
testing and disposition, donor
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
68133
management, methods for donor
requalification, and product labeling.
In addition, FDA is notifying those
blood establishments that FDA
considers the use of an FDA-licensed
HBV NAT to be necessary to reduce
adequately and appropriately the risk of
transmission of HBV. FDA-licensed
HBV NAT can detect evidence of
infection at an earlier stage than is
possible using previously approved
HBsAg and anti-HBc tests. Therefore,
FDA is recommending the use FDAlicensed HBV NAT, in accordance with
the requirements under Title 21 Code of
Federal Regulations, 610.40(a) and (b)
(21 CFR 610.40(a) and (b)).
The guidance supplements previous
memoranda and guidance from FDA to
blood establishments concerning the
testing of donations for HBsAg and antiHBc, and the management of donors and
donations mentioned in those
documents. Note that testing Whole
Blood and blood components for
transfusion and Source Leukocytes for
further manufacture for HBsAg and antiHBc, and Source Plasma for HBsAg,
should continue when a blood
establishment implements HBV NAT.
FDA may consider advancements in
technology for testing blood donations,
as well as data obtained following the
implementation of HBV NAT, to make
future recommendations on adequate
and appropriate testing for HBV.
In the Federal Register of November
28, 2011 (76 FR 72950), FDA announced
the availability of the draft guidance of
the same title, dated November 2011.
FDA received several comments on the
draft guidance and those comments
were considered as the guidance was
finalized. In addition to minor editorial
changes made to improve clarity,
changes to the draft guidance include
revised labeling recommendations and
an extension of the time for
implementation of the guidance to 6
months after publication of the final
guidance. The guidance announced in
this notice finalizes the draft guidance
dated November 2011.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents FDA’s current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
E:\FR\FM\15NON1.SGM
15NON1
68134
Federal Register / Vol. 77, No. 221 / Thursday, November 15, 2012 / Notices
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
§ 601.12 and in §§ 606.121 and 610.40
have been approved under OMB control
numbers 0910–0338 and 0910–0116,
respectively.
III. Comments
plans and instruments, contact: Dr.
Amanda Greene, Office of Science
Policy and Public Liaison, NINR, NIH,
Democracy One, 6701 Democracy Blvd.,
Suite 700, Bethesda, MD 20892 or call
non-toll-free number (301) 496–9601 or
Email your request, including your
address to: amanda.greene@nih.gov.
Comments regarding this information
collection are best assured of having
their full effect if received within 30days of the date of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY:
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either http:
//www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27783 Filed 11–14–12; 8:45 am]
BILLING CODE 4160–01–P
National Institutes of Health
Submission for OMB Review;
Comment Request (30-day): National
Institute of Nursing Research (NINR)
Summer Genetics Institute Alumni
Survey
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This information
collection was previously published in
the Federal Register on June 29, 2012,
page 38840 and allowed 60-days for
public comment. No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the:
Office of Management and Budget,
Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
Proposed Collection: National Institute
of Nursing Research (NINR) Summer
Genetics Institute Alumni Survey,
–0925–New
Need and Use of Information
Collection: The NINR Summer Genetics
Institute Alumni Survey will obtain
information on the long-term outcomes
of the NINR Summer Genetics Institute
training program for nurse scientists and
faculty. Target participants are alumni
of this training institute which began in
2000. The survey inquires about career
activities, including research, clinical,
teaching and educational activities,
since completion of the NINR Summer
Genetics Institute. This is a 39-item
survey that takes an average of 30
minutes to complete. The findings will
provide valuable information on the
influence of the Institute in developing
genetics research capability among
Institute alumni, and development and
expansion of clinical practice in
genetics among alumni who are nurse
clinicians.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
75.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Number of
respondents
Frequency of
response
Average time
per response
(in hours)
Total burden
hours
Researchers .....................................................................................................
150
1
30/60
75
Dated: November 2, 2012.
Amanda Greene,
Project Clearance Liaison, NINR, National
Institutes of Health.
[FR Doc. 2012–27578 Filed 11–14–12; 8:45 am]
TKELLEY on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Interagency Autism Coordinating
Committee (IACC) Subcommittee for
Services Research and Policy.
VerDate Mar<15>2010
16:22 Nov 14, 2012
Jkt 229001
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
The IACC Subcommittee for Services
Research and Policy will be having a
webinar/conference call on Tuesday,
November 27, 2012. The Subcommittee
will discuss and vote on draft Updates
for Chapters 5 and 6 of the 2012 IACC
Strategic Plan, which include services
and lifespan issues. These Updates will
describe recent progress that has been
made in the autism field as well as any
new gap areas in research that have
emerged since the previously released
2011 Strategic Plan. The meeting will be
open to the public and accessible by
webinar and conference call.
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68133-68134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27783]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0799]
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and
Individual Samples From Donors of Whole Blood and Blood Components,
Including Source Plasma, To Reduce the Risk of Transmission of
Hepatitis B Virus; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Use of
Nucleic Acid Tests on Pooled and Individual Samples from Donors of
Whole Blood and Blood Components, including Source Plasma, to Reduce
the Risk of Transmission of Hepatitis B Virus,'' dated October 2012.
The guidance document provides recommendations on the use of FDA-
licensed nucleic acid tests (NAT) to screen blood donors for hepatitis
B virus (HBV) deoxyribonucleic acid (DNA) and recommendations for
product testing and disposition, donor management, methods for donor
requalification, and product labeling. In addition, the guidance
provides notification that FDA considers the use of an FDA-licensed HBV
NAT to be necessary to reduce adequately and appropriately the risk of
transmission of HBV. The guidance is intended for blood establishments
that collect Whole Blood and blood components for transfusion or for
further manufacture, including recovered plasma, Source Plasma and
Source Leukocytes. The guidance announced in this notice finalizes the
draft guidance of the same title, dated November 2011. The guidance
also supplements previous memoranda and guidance from FDA concerning
the testing of donations for hepatitis B surface antigen (HBsAg) and
antibody to hepatitis B core antigen (anti-HBc) and the management of
donors and donations mentioned in those documents.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Use of Nucleic Acid Tests on Pooled and
Individual Samples from Donors of Whole Blood and Blood Components,
including Source Plasma, to Reduce the Risk of Transmission of
Hepatitis B Virus,'' dated October 2012. FDA is providing blood
establishments that collect Whole Blood and blood components for
transfusion or for further manufacture, including recovered plasma,
Source Plasma and Source Leukocytes, with recommendations concerning
the use of FDA-licensed NAT to screen blood donors for HBV DNA. FDA is
also providing these blood establishments with recommendations for
product testing and disposition, donor management, methods for donor
requalification, and product labeling.
In addition, FDA is notifying those blood establishments that FDA
considers the use of an FDA-licensed HBV NAT to be necessary to reduce
adequately and appropriately the risk of transmission of HBV. FDA-
licensed HBV NAT can detect evidence of infection at an earlier stage
than is possible using previously approved HBsAg and anti-HBc tests.
Therefore, FDA is recommending the use FDA-licensed HBV NAT, in
accordance with the requirements under Title 21 Code of Federal
Regulations, 610.40(a) and (b) (21 CFR 610.40(a) and (b)).
The guidance supplements previous memoranda and guidance from FDA
to blood establishments concerning the testing of donations for HBsAg
and anti-HBc, and the management of donors and donations mentioned in
those documents. Note that testing Whole Blood and blood components for
transfusion and Source Leukocytes for further manufacture for HBsAg and
anti-HBc, and Source Plasma for HBsAg, should continue when a blood
establishment implements HBV NAT. FDA may consider advancements in
technology for testing blood donations, as well as data obtained
following the implementation of HBV NAT, to make future recommendations
on adequate and appropriate testing for HBV.
In the Federal Register of November 28, 2011 (76 FR 72950), FDA
announced the availability of the draft guidance of the same title,
dated November 2011. FDA received several comments on the draft
guidance and those comments were considered as the guidance was
finalized. In addition to minor editorial changes made to improve
clarity, changes to the draft guidance include revised labeling
recommendations and an extension of the time for implementation of the
guidance to 6 months after publication of the final guidance. The
guidance announced in this notice finalizes the draft guidance dated
November 2011.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirement of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These
[[Page 68134]]
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in Sec. 601.12
and in Sec. Sec. 606.121 and 610.40 have been approved under OMB
control numbers 0910-0338 and 0910-0116, respectively.
III. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: November 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27783 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P
