Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations; Public Workshop, 16513-16514 [2013-05987]
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Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices
and is authorized to assist States in the
prevention and suppression of
communicable diseases. Under this
authority, FDA participates with State
regulatory agencies, some foreign
nations, and the molluscan shellfish
industry in the National Shellfish
Sanitation Program (NSSP).
NSSP is a voluntary, cooperative
program to promote the safety of
molluscan shellfish by providing for the
classification and patrol of shellfish
growing waters and for the inspection
and certification of shellfish processors.
Each participating State and foreign
nation monitors its molluscan shellfish
processors and issues certificates for
those that meet the State or foreign
shellfish control authority’s criteria.
Each participating State and nation
provides a certificate of its certified
shellfish processors to FDA on Form
FDA 3038, ‘‘Interstate Shellfish Dealer’s
Certificate.’’ FDA uses this information
to publish the ‘‘Interstate Certified
Shellfish Shippers List,’’ a monthly
comprehensive listing of all molluscan
shellfish processors certified under the
cooperative program. If FDA did not
collect the information necessary to
compile this list, participating States
would not be able to identify and keep
out shellfish processed by uncertified
processors in other States and foreign
nations. Consequently, NSSP would not
be able to control the distribution of
uncertified and possibly unsafe shellfish
in interstate commerce, and its
effectiveness would be nullified.
In the Federal Register of November
15, 2012 (77 FR 68129), FDA published
a 60-day notice requesting public
comment on the proposed extension of
this collection of information. FDA
received one letter in response to the
notice, containing multiple comments
on the testing methods used by certified
shellfish processors in the NSSP. These
comments were outside the scope of the
four collection-of-information topics on
which the notice requested comments,
and will not be discussed in this
document. FDA estimates the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submission of Interstate Shellfish Dealer’s Certificate ......................................
3038
40
57
2,280
0.10
228
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that 40 respondents
will submit 2,280 Interstate Shellfish
Dealer’s Certificates annually, for a total
burden of 228 hours (2,280 submissions
× 0.10 hours = 228 hours). This estimate
is based on FDA’s experience and the
number of certificates received in the
past 3 years.
Dated: March 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05970 Filed 3–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Application of Advances in Nucleic
Acid and Protein Based Detection
Methods to Multiplex Detection of
Transfusion-Transmissible Agents and
Blood Cell Antigens in Blood
Donations; Public Workshop
AGENCY:
Food and Drug Administration,
srobinson on DSK4SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Application of Advances in
Nucleic Acid and Protein Based
Detection Methods to Multiplex
Detection of Transfusion-Transmissible
Agents and Blood Cell Antigens in
VerDate Mar<14>2013
17:37 Mar 14, 2013
Jkt 229001
Blood Donations.’’ The purpose of this
public workshop is to discuss research
and development of multiplex assays
and the use of these tests in blood donor
screening and blood cell antigen typing.
The public workshop has been planned
in partnership with the AABB (formerly
known as the American Association of
Blood Banks), Advanced Medical
Technology Association (AdvaMed),
America’s Blood Centers, Department of
Defense, Department of Health and
Human Services Office of the Assistant
Secretary for Health, and the National
Heart, Lung and Blood Institute,
National Institutes of Health. The public
workshop will include presentations
and panel discussions by experts from
academic institutions, blood
establishments, industry, and
government agencies.
Date and Time: The public workshop
will be held on April 10, 2013, from 8
a.m. to 5:30 p.m., and April 11, 2013,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held in the Main Auditorium,
Natcher Conference Center, National
Institutes of Health, Bldg. 45, Bethesda,
MD 20892.
Contact Person: Jennifer Scharpf,
Center for Biologics Evaluation and
Research (HFM–300), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6128, FAX: 301–827–2843,
email:
CBEROBRRWorkshops@fda.hhs.gov.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
Registration: Mail, fax, or email your
registration information (including
name, title, firm name, address,
telephone and fax numbers, and email
address) to Jennifer Scharpf (see Contact
Person) by April 1, 2013. There is no
registration fee for the public workshop.
Early registration is recommended
because seating is limited. Registration
on the day of the public workshop will
be provided on a space available basis
beginning at 7:30 a.m. If you need
special accommodations due to a
disability, please contact Jennifer
Scharpf (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION: The
objectives of the workshop are to review
the status of multiplex platforms and
the technological advances in gene
based and protein based pathogen and
blood cell antigen detection methods
and to discuss the scientific pathways to
support the development of multiplex
assays to screen blood donors for bloodborne pathogens and blood cell antigen
typing.
The first day of this workshop will
include presentations and panel
discussions on the following topics: (1)
Blood safety and infectious agents, (2)
advances in blood-borne pathogen
detection, and (3) molecular DNA-based
typing of blood cell antigens.
The second day of the workshop will
include presentations and discussion on
the following topics: (1) Highly
multiplexed technologies in blood
donor screening; (2) bioinformatics, data
E:\FR\FM\15MRN1.SGM
15MRN1
16514
Federal Register / Vol. 78, No. 51 / Friday, March 15, 2013 / Notices
analysis, and data management issues;
(3) perspectives in developing multiplex
devices for donor screening; and (4)
workshop summary and conclusions.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857.
Dated: March 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05987 Filed 3–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children; Notice of Meeting
srobinson on DSK4SPTVN1PROD with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463, codified at 5 U.S.C.
App. 2), notice is hereby given of the
following meeting:
Name: Secretary’s Advisory Committee on
Heritable Disorders in Newborns and
Children (SACHDNC).
Date and Time: April 19, 2013, 9:30 a.m.
to 3:00 p.m.
Place: Virtual via Webinar.
Status: The meeting is open to the public.
Pre-registration is required. For more
information on registration and webinar
details, please visit the SACHDNC Web site:
https://www.hrsa.gov/advisorycommittees/
mchbadvisory/heritabledisorders.
Purpose: The Secretary’s Advisory
Committee on Heritable Disorders in
Newborns and Children (SACHDNC), as
authorized by Public Law 106–310, which
added section 1111 of the Public Health
Service Act, codified at 42 U.S.C. 300b–10,
was established by Congress to advise the
Secretary of the Department of Health and
Human Services regarding the development
of newborn screening activities, technologies,
policies, guidelines, and programs for
effectively reducing morbidity and mortality
in newborns and children having, or at risk
for, heritable disorders. The SACHDNC’s
recommendations regarding additional
conditions/inherited disorders for screening
that have been adopted by the Secretary are
included in the Recommended Uniform
Screening Panel (RUSP) that constitutes part
of the comprehensive guidelines supported
by the Health Resources and Services
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17:37 Mar 14, 2013
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Administration. Pursuant to section 2713 of
the Public Health Service Act, codified at 42
U.S.C. 300gg–13, non-grandfathered health
plans are required to cover screenings
included in the comprehensive guidelines
without charging a co-payment, co-insurance,
or deductible for plan years (i.e., policy
years) beginning on or after the date that is
one year from the Secretary’s adoption of the
condition for screening. The SACHDNC also
provides advice and recommendations
concerning grants and projects authorized
under section 1109 of the Public Health
Service Act (42 U.S.C. 300b–8).
Agenda: The meeting will include: (1) A
policy paper report on the impact of
recommendations related to sickle cell trait
testing; (2) a presentation on the Affordable
Care Act and the impact on individuals with
heritable disorders; (3) a presentation by the
Agency for Healthcare Research and Quality
regarding the processes behind the U.S.
Preventive Services Task Force review
process; and (4) project reports on screening
for Tyrosinemia Type I and Point of Care
Screening and Lessons Learned.
Proposed agenda items are subject to
change as priorities dictate. The agenda,
webinar information, Committee Roster,
Charter, presentations, and meeting materials
are located on the Advisory Committee’s Web
site at https://www.hrsa.gov/
advisorycommittees/mchbadvisory/
heritabledisorders.
Public Comments: Members of the public
can submit written comments and/or register
to present oral comments. All comments,
whether oral or written, are part of the
official Committee record and will be
available for public inspection and copying.
Individuals who wish to make public
comments are required to register for the
webinar and email Lisa Vasquez
(lvasquez@hrsa.gov) by April 10, 2013. The
public comment period is scheduled for the
morning of April 19, 2013. Written comments
should be emailed to Lisa Vasquez
(lvasquez@hrsa.gov) by April 10, 2013.
Written comments should identify the
individual’s name, address, email, telephone
number, professional or business affiliation,
type of expertise (i.e., parent, researcher,
clinician, public health, etc.) and the topic/
subject matter of comment. To ensure that all
individuals who have registered to make oral
comments can be accommodated, the
allocated time may be limited. Individuals
who are associated with groups or have
similar interests may be requested to
combine their comments and present them
through a single representative. No
audiovisual presentations are permitted.
Contact Person: Anyone interested in
obtaining other relevant information should
contact the designated federal officer (DFO),
Debi Sarkar, Maternal and Child Health
Bureau, Health Resources and Services
Administration, Room 18A–19, Parklawn
Building, 5600 Fishers Lane, Rockville,
Maryland 20857; telephone: 301–443–1080;
email: dsarkar@hrsa.gov.
More information on the Advisory
Committee is available at https://
www.hrsa.gov/advisorycommittees/
mchbadvisory/heritabledisorders.
PO 00000
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Fmt 4703
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Dated: March 11, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–06042 Filed 3–14–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 78 FR 14311–14312,
dated March 5, 2013).
This notice reflects organizational
changes to the Health Resources and
Services Administration. This notice
updates the functional statement for the
Bureau of Primary Health Care (RC).
Specifically, this notice: (1) Establishes
the Office of National Assistance and
Special Populations (RCE); (2) abolishes
the Office of Training and Technical
Assistance Coordination (RCS) and the
Office of Special Population Health
(RCG); and (3) updates the functional
statement for the Office of the Associate
Administrator (RC), the Office of
Administrative Management (RCM), the
Office of Policy and Program
Development (RCH), and the Office of
Quality and Data (RCK).
Chapter RC—Bureau of Primary Health
Care
Section RC–10, Organization
Delete in its entirety and replace with
the following:
The Bureau of Primary Health Care
(RC) is headed by the Associate
Administrator, who reports directly to
the Administrator, Health Resources
and Services Administration. The
Bureau of Primary Health Care includes
the following components:
(1) Office of the Associate
Administrator (RC);
(2) Office of Administrative
Management (RCM);
(3) Office of Policy and Program
Development (RCH);
(4) Office of Quality and Data (RCK);
(5) Office of National Assistance and
Special Populations (RCE);
(6) Northeast Division (RCU);
(7) Central Southeast Division (RCV);
(8) North Central Division (RCT); and
E:\FR\FM\15MRN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16513-16514]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05987]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Application of Advances in Nucleic Acid and Protein Based
Detection Methods to Multiplex Detection of Transfusion-Transmissible
Agents and Blood Cell Antigens in Blood Donations; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: ``Application of Advances in Nucleic Acid and
Protein Based Detection Methods to Multiplex Detection of Transfusion-
Transmissible Agents and Blood Cell Antigens in Blood Donations.'' The
purpose of this public workshop is to discuss research and development
of multiplex assays and the use of these tests in blood donor screening
and blood cell antigen typing. The public workshop has been planned in
partnership with the AABB (formerly known as the American Association
of Blood Banks), Advanced Medical Technology Association (AdvaMed),
America's Blood Centers, Department of Defense, Department of Health
and Human Services Office of the Assistant Secretary for Health, and
the National Heart, Lung and Blood Institute, National Institutes of
Health. The public workshop will include presentations and panel
discussions by experts from academic institutions, blood
establishments, industry, and government agencies.
Date and Time: The public workshop will be held on April 10, 2013,
from 8 a.m. to 5:30 p.m., and April 11, 2013, from 8 a.m. to 5 p.m.
Location: The public workshop will be held in the Main Auditorium,
Natcher Conference Center, National Institutes of Health, Bldg. 45,
Bethesda, MD 20892.
Contact Person: Jennifer Scharpf, Center for Biologics Evaluation
and Research (HFM-300), Food and Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6128, FAX: 301-827-
2843, email: CBEROBRRWorkshops@fda.hhs.gov.
Registration: Mail, fax, or email your registration information
(including name, title, firm name, address, telephone and fax numbers,
and email address) to Jennifer Scharpf (see Contact Person) by April 1,
2013. There is no registration fee for the public workshop. Early
registration is recommended because seating is limited. Registration on
the day of the public workshop will be provided on a space available
basis beginning at 7:30 a.m. If you need special accommodations due to
a disability, please contact Jennifer Scharpf (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: The objectives of the workshop are to review
the status of multiplex platforms and the technological advances in
gene based and protein based pathogen and blood cell antigen detection
methods and to discuss the scientific pathways to support the
development of multiplex assays to screen blood donors for blood-borne
pathogens and blood cell antigen typing.
The first day of this workshop will include presentations and panel
discussions on the following topics: (1) Blood safety and infectious
agents, (2) advances in blood-borne pathogen detection, and (3)
molecular DNA-based typing of blood cell antigens.
The second day of the workshop will include presentations and
discussion on the following topics: (1) Highly multiplexed technologies
in blood donor screening; (2) bioinformatics, data
[[Page 16514]]
analysis, and data management issues; (3) perspectives in developing
multiplex devices for donor screening; and (4) workshop summary and
conclusions.
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857.
Dated: March 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05987 Filed 3-14-13; 8:45 am]
BILLING CODE 4160-01-P
