National Advisory Committee on Rural Health and Human Services; Notice of Meeting, 25696-25697 [2011-10983]
Download as PDF
<![CDATA[
25696
Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Notices
[FR Doc. 2011–10949 Filed 5–4–11; 8:45 am]
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Spencer Salis, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Building 51, rm. 5216,
Silver Spring, MD 20993–0002, 301–
796–3327.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4163–18–P
I. Background
Guide for Syndromic Surveillance
available for public comment at https://
www.regulations.gov and https://
www.cdc.gov/phin/library/2011/guides/
Syndromic_Surveillance_
Implementation_Guide_Release_1_4.pdf
Dated: April 27, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0322]
Guidance for Industry on Dosage
Delivery Devices for Orally Ingested
OTC Liquid Drug Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Dosage Delivery Devices for
Orally Ingested OTC Liquid Drug
Products.’’ This document is intended to
provide guidance to firms that are
manufacturing, marketing, or
distributing orally ingested over-thecounter (OTC) liquid drug products
packaged with dosage delivery devices
(e.g., calibrated cups, droppers,
syringes, or spoons). FDA is issuing this
guidance because of ongoing concerns
about potentially serious accidental
drug overdoses that can result from the
use of dosage delivery devices with
markings that are inconsistent or
incompatible with the labeled dosage
directions for orally ingested OTC liquid
drug products.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. 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–
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:22 May 04, 2011
Jkt 223001
FDA is announcing the availability of
a guidance for industry entitled ‘‘Dosage
Delivery Devices for Orally Ingested
OTC Liquid Drug Products.’’ The
Agency has determined that many orally
ingested OTC liquid drug products in
the marketplace are packaged with
dosage delivery devices that bear
markings that are inconsistent with the
labeled dosage directions, contain
superfluous markings, or are missing
necessary markings. FDA is issuing this
guidance because of ongoing concerns
about potentially serious accidental
drug overdoses that can result from the
use of dosage delivery devices with
markings that are inconsistent or
incompatible with the labeled dosage
directions for orally ingested OTC drug
products. FDA recommends that dosage
delivery devices be included for all
orally ingested OTC drug products that
are liquid formulations, that they should
bear markings that are consistent with
the labeled dosage directions, and that
they should be labeled in a manner that
attempts to ensure that they are used
only with the products with which they
are included.
In the Federal Register of November
5, 2009 (74 FR 57319), FDA announced
the availability of a draft guidance for
industry entitled ‘‘Dosage Delivery
Devices for Over-the-Counter Liquid
Drug Products.’’ The notice gave
interested persons an opportunity to
comment by February 2, 2010. We
received a number of comments from
individuals, firms, and consumer
groups. We have carefully considered
the comments and, where appropriate,
have made corrections, added
information, or clarified the information
in the guidance in response to the
comments or on our own initiative.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on dosage delivery
devices for orally ingested OTC liquid
drug products. 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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
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.
Dated: April 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–10965 Filed 5–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
that the following committee will
convene its sixty-seventh meeting.
Name: National Advisory Committee on
Rural Health and Human Services.
Dates and Times: June 15, 2011, 9 a.m.–
4:45 p.m., June 16, 2011, 9 a.m.–4:45 p.m.,
June 17, 2011, 8:45 a.m.–10:30 a.m.
Place: Park Place Hotel, 300 East State
Street, Traverse City, MI 49684. (231) 946–
5000.
Status: The meeting will be open to the
public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations of health and human
services in rural areas.
Agenda: Wednesday morning, at 9 a.m.,
the meeting will be called to order by the
Chairperson of the Committee, the Honorable
Ronnie Musgrove. The first three
presentations will be overviews of rural
Michigan and the relevant health indicators.
The remainder of the day the Committee will
hear presentations on two of the chosen
E:\FR\FM\05MYN1.SGM
05MYN1
Federal Register / Vol. 76, No. 87 / Thursday, May 5, 2011 / Notices
Subcommittee topics. The first panel will
focus on the impact of Value-Based
Purchasing Demonstrations. The second
panel will focus on primary care training and
placement. The Subcommittees will then
move into breakout sessions to further
discuss these topics. After the panel
discussions, the Committee Chair will give
an overview of the site visits. This will be
followed by a call for public comment. The
Wednesday meeting will close at 4:45 p.m.
Thursday morning, at 9 a.m., the
Committee will travel to Munson Medical
Center for a briefing on its role in serving the
region. At 10 a.m. the Committee will break
into Subcommittees and depart to the site
visits. The Value-Based Purchasing
Demonstrations Subcommittee will meet at
Mercy Cadillac Hospital in Cadillac, MI. The
Primary Care Training and Placement
Subcommittee will meet at Kalkaska Rural
Health Clinic in Kalkaska, MI. The
Subcommittees will return to the Park Place
Hotel in Traverse City at 4 p.m.
Transportation to the site visits will not be
provided to the public. The Thursday
meeting will close at 4:45 p.m.
The Final session will be convened on
Friday morning at 8:45 am. The meeting will
open with a review of the Subcommittee site
visits. The Committee will draft a letter to the
Secretary or Designee and discuss the
September 2011 meeting. The meeting will
adjourn at 10:30 a.m.
For Further Information Contact: Thomas
Morris, MPA, Executive Secretary, National
Advisory Committee on Rural Health and
Human Services, Health Resources and
Services Administration, Parklawn Building,
Room 10B–45, 5600 Fishers Lane, Rockville,
MD 20857, Telephone (301) 443–0835, Fax
(301) 443–2803.
Persons interested in attending any portion
of the meeting should contact Deborah
DeMasse-Snell at the Office of Rural Health
Policy (ORHP) via Telephone at (301) 443–
0835 or by e-mail at ddemassesnell@hrsa.gov. The committee meeting
agenda will be posted on ORHP’s Web site
https://www.ruralhealth.hrsa.gov.
Dated: April 28, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–10983 Filed 5–4–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on DSKJ8SOYB1PROD with NOTICES
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
SUMMARY:
VerDate Mar<15>2010
17:22 May 04, 2011
Jkt 223001
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Improved Standard for Immune System
Recovery Assay
Description of Invention: Monitoring
an immune system that has been
depleted by infection (e.g., HIV),
chemotherapy, or progenitor cell
transplantation is vital to assessing
individual’s recovery status. This
technology provides a new plasmid
standard to be used as part of the
existing TREC assay. This new plasmid
has a shorter insert than the
commercially available one, which
means it now matches the PCR product
generated in the qPCR reaction in the
TREC assay. Additionally, the new
plasmid is easier to grow up than the
existing standard.
Applications: TREC assay for T-cell
concentration measurements.
Advantages:
• The insert of standard plasmid is
shorter and directly matches the PCR
product generated in the qPCR reaction.
• The standard plasmid is easy to
grow up.
Development Status: Fully developed.
Inventors: Daniel C. Douek, Richard
A. Koup, Brenna J. Hill (NIAID.)
Relevant Publications:
1. Douek et al. Changes in thymic
function with age and during the
treatment of HIV infection. Nature 1998
Dec 17;396(6712):690–695. [PubMed:
9872319.]
2. Douek et al. Assessment of thymic
output in adults after haematopoietic
stem-cell transplantation and prediction
of T-cell reconstitution. Lancet 2000
May 27;355(9218):1875–1881. [PubMed:
10866444.]
Patent Status: HHS Reference No. E–
067–2011/0—Research Material. Patent
protection is not being pursued for this
technology.
Licensing Status: Research tool
available for non-exclusive licensing.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
25697
Licensing Contact: Susan Ano, Ph.D.;
301–435–5515; anos@mail.nih.gov.
Glucocerebrosidase Activators as a
Treatment for Gaucher Disease
Description of Invention: This
technology is a collection of small
molecule activators of a genetically
defective version of the enzyme called
glucocerebrosidase (GCase), which
causes Gaucher disease. Gaucher
disease is a rare disease affecting 1 in
40,000 babies born. Ashkenazi Jews of
eastern European descent (about 1 in
800 live births) are at particular risk of
carrying this genetic defect. It is caused
by inherited genetic mutations in the
gene that encodes GCase, which result
in reduced activity of the enzyme. This
enzyme is normally made and then
transported to an organelle called a
lysosome, which is dedicated to the
degradation and disposal of molecules
the cell no longer needs. GCase is
responsible for the breakdown of a fatty
material called glucocerebroside (or
glucosylceramide). The accumulation of
this lipid occurs inside specific cells
called macrophages and macrophagederived cells. The disease has been
categorized into three types:
neuronopathic (types 2, 3) and nonneuronopathic (type 1) with mild to
severe symptoms that can appear at
anytime from infancy to adulthood.
Clinical manifestations can include an
enlarged spleen and liver, anemia,
decreased platelets, bone disease and
neurodegeneration, with varying
severity depending on the type of
disease and time of diagnosis. The
deficient GCase activity has been
attributed to insufficient GCase enzyme
in the lysosome. After production in the
endoplasmic reticulum (ER), defective
GCase does not fold properly and is
therefore degraded in the ER and not
transported to the lysosome where it
would hydrolyze glucocerebroside. The
small molecule activators may act by
increasing the concentration of GCase
that reaches the lysosome by facilitating
the proper folding of GCase so that it
can be released from the ER and
transported to lysosomes. Thus, these
small molecules could be acting like
‘‘chaperones,’’ because they facilitate
proper folding which results in some
active enzyme. Prior failed attempts to
use small molecule chaperones to
improve GCase folding and transport
were made with inhibitors of GCase,
which ironically properly folded active
GCase that was subsequently
transported to the lysosome, but the
molecule also inhibited the GCase co
that it could not break down
glucocerebroside. On the other hand,
these proposed small molecules were
E:\FR\FM\05MYN1.SGM
05MYN1
]]>Agencies
[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25696-25697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10983]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services;
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given that the
following committee will convene its sixty-seventh meeting.
Name: National Advisory Committee on Rural Health and Human
Services.
Dates and Times: June 15, 2011, 9 a.m.-4:45 p.m., June 16, 2011,
9 a.m.-4:45 p.m., June 17, 2011, 8:45 a.m.-10:30 a.m.
Place: Park Place Hotel, 300 East State Street, Traverse City,
MI 49684. (231) 946-5000.
Status: The meeting will be open to the public.
Purpose: The National Advisory Committee on Rural Health and
Human Services provides advice and recommendations of health and
human services in rural areas.
Agenda: Wednesday morning, at 9 a.m., the meeting will be called
to order by the Chairperson of the Committee, the Honorable Ronnie
Musgrove. The first three presentations will be overviews of rural
Michigan and the relevant health indicators. The remainder of the
day the Committee will hear presentations on two of the chosen
[[Page 25697]]
Subcommittee topics. The first panel will focus on the impact of
Value-Based Purchasing Demonstrations. The second panel will focus
on primary care training and placement. The Subcommittees will then
move into breakout sessions to further discuss these topics. After
the panel discussions, the Committee Chair will give an overview of
the site visits. This will be followed by a call for public comment.
The Wednesday meeting will close at 4:45 p.m.
Thursday morning, at 9 a.m., the Committee will travel to Munson
Medical Center for a briefing on its role in serving the region. At
10 a.m. the Committee will break into Subcommittees and depart to
the site visits. The Value-Based Purchasing Demonstrations
Subcommittee will meet at Mercy Cadillac Hospital in Cadillac, MI.
The Primary Care Training and Placement Subcommittee will meet at
Kalkaska Rural Health Clinic in Kalkaska, MI. The Subcommittees will
return to the Park Place Hotel in Traverse City at 4 p.m.
Transportation to the site visits will not be provided to the
public. The Thursday meeting will close at 4:45 p.m.
The Final session will be convened on Friday morning at 8:45 am.
The meeting will open with a review of the Subcommittee site visits.
The Committee will draft a letter to the Secretary or Designee and
discuss the September 2011 meeting. The meeting will adjourn at
10:30 a.m.
For Further Information Contact: Thomas Morris, MPA, Executive
Secretary, National Advisory Committee on Rural Health and Human
Services, Health Resources and Services Administration, Parklawn
Building, Room 10B-45, 5600 Fishers Lane, Rockville, MD 20857,
Telephone (301) 443-0835, Fax (301) 443-2803.
Persons interested in attending any portion of the meeting
should contact Deborah DeMasse-Snell at the Office of Rural Health
Policy (ORHP) via Telephone at (301) 443-0835 or by e-mail at
ddemasse-snell@hrsa.gov. The committee meeting agenda will be posted
on ORHP's Web site https://www.ruralhealth.hrsa.gov.
Dated: April 28, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-10983 Filed 5-4-11; 8:45 am]
BILLING CODE 4165-15-P
