Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing; Public Workshop, 11028 [E7-4313]
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11028
Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices
Dated: March 6, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–1144 Filed 3–9–07; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Immune Globulins for Primary Immune
Deficiency Diseases: Antibody
Specificity, Potency and Testing;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: Immune Globulins for Primary
Immune Deficiency Diseases: Antibody
Specificity, Potency and Testing. The
purpose of the public workshop is to
discuss approaches to identify the most
relevant antibody specificities in
Immune Globulins for the prevention of
infections in patients with primary
immune deficiency diseases (PIDD), and
current and potential potency tests for
Immune Globulins. The public
workshop will also include a discussion
about the declining measles antibody
levels in U.S. licensed Immune
Globulins and the potential clinical
impact on patients with PIDD. The
public workshop sponsors are FDA, the
Immune Deficiency Foundation, and the
Plasma Protein Therapeutics
Association.
Date and Time: The public workshop
will be held on April 25, 2007, from 8
a.m. to 5 p.m., and April 26, 2007, from
8:30 a.m. to 11:30 a.m.
Location: The public workshop will
be held at the Lister Hill Center
Auditorium, Building 38A, National
Institutes of Health, 8800 Rockville
Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail or fax your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person by April 6, 2007. 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
VerDate Aug<31>2005
18:04 Mar 09, 2007
Jkt 211001
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson at least 7 days in
advance of the workshop.
SUPPLEMENTARY INFORMATION: The
public workshop will feature
presentations by national and
international experts from government,
academic institutions, and industry. The
first day of the workshop will include
discussions on: (1) Epidemiology of
serious infections in PIDD patients; (2)
review of European and U.S. PIDD
registry data; (3) surveillance questions
to address the type, rate, and severity of
infections in PIDD patients; (4) rationale
for current potency tests for Immune
Globulins; (5) antibody levels in current
Immune Globulins, including those
levels to emerging pathogens; and (6)
the development of additional or other
useful potency tests. The second day of
the workshop will focus on the potential
clinical impact on PIDD patients of
declining measles antibody levels in
U.S. licensed Immune Globulins.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
Dated: March 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–4313 Filed 3–9–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to Office of Management
and Budget (OMB) under the Paperwork
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Healthcare Integrity
and Protection Data Bank for Final
Adverse Information on Health Care
Providers, Suppliers, and Practitioners
(OMB No. 0915–0239)—Extension
Section 221 (a) of the Health
Insurance Portability and
Accountability Act (HIPAA) of 1996
specifically directs the Secretary to
establish a national health care fraud
and abuse data collection program for
the reporting and disclosure of certain
final adverse actions taken against
health care providers, suppliers, and
practitioners. A final rule was published
October 26, 1999, in the Federal
Register to implement the statutory
requirements of section 1128E of the
Social Security Act (The Act) as added
by section 221 (a) of HIPAA. The Act
requires the Secretary to implement the
national health care fraud and abuse
data collection program. This data bank
is known as the Healthcare Integrity and
Protection Data Bank (HIPDB). It
contains the following types of
information: (1) Civil judgments against
a health care provider, supplier, or
practitioner in Federal or State court
related to the delivery of a health care
item or service; (2) Federal or State
criminal convictions against a health
care provider, supplier, or practitioner
related to the delivery of a health care
item or service; (3) actions by Federal or
State agencies responsible for the
licensing and certification of health care
providers, suppliers, or practitioners; (4)
exclusion of a health care provider,
practitioner or supplier from
participation in Federal or State health
care programs; and (5) any other
adjudicated actions or decisions that the
Secretary shall establish by regulations.
Access to this data bank is limited to
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 72, Number 47 (Monday, March 12, 2007)]
[Notices]
[Page 11028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-4313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Immune Globulins for Primary Immune Deficiency Diseases: Antibody
Specificity, Potency and Testing; 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: Immune Globulins for Primary Immune Deficiency
Diseases: Antibody Specificity, Potency and Testing. The purpose of the
public workshop is to discuss approaches to identify the most relevant
antibody specificities in Immune Globulins for the prevention of
infections in patients with primary immune deficiency diseases (PIDD),
and current and potential potency tests for Immune Globulins. The
public workshop will also include a discussion about the declining
measles antibody levels in U.S. licensed Immune Globulins and the
potential clinical impact on patients with PIDD. The public workshop
sponsors are FDA, the Immune Deficiency Foundation, and the Plasma
Protein Therapeutics Association.
Date and Time: The public workshop will be held on April 25, 2007,
from 8 a.m. to 5 p.m., and April 26, 2007, from 8:30 a.m. to 11:30 a.m.
Location: The public workshop will be held at the Lister Hill
Center Auditorium, Building 38A, National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail or fax your registration information (including
name, title, firm name, address, telephone and fax numbers) to the
contact person by April 6, 2007. 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 Rhonda Dawson at least 7 days in advance of the workshop.
SUPPLEMENTARY INFORMATION: The public workshop will feature
presentations by national and international experts from government,
academic institutions, and industry. The first day of the workshop will
include discussions on: (1) Epidemiology of serious infections in PIDD
patients; (2) review of European and U.S. PIDD registry data; (3)
surveillance questions to address the type, rate, and severity of
infections in PIDD patients; (4) rationale for current potency tests
for Immune Globulins; (5) antibody levels in current Immune Globulins,
including those levels to emerging pathogens; and (6) the development
of additional or other useful potency tests. The second day of the
workshop will focus on the potential clinical impact on PIDD patients
of declining measles antibody levels in U.S. licensed Immune Globulins.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: March 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4313 Filed 3-9-07; 8:45 am]
BILLING CODE 4160-01-S
