Health Center Program, 66979-66980 [E9-30010]
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wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Notices
which, according to ATSDR and U.S.
EPA, pose the most significant potential
threat to human health. The availability
of the revised priority list of 275
hazardous substances was announced in
the Federal Register on March 6, 2008
(73 FR 12178). In addition, ATSDR has
the authority to prepare toxicological
profiles for substances not found at sites
on the National Priorities List, in an
effort to ‘‘* * * establish and maintain
inventory of literature, research, and
studies on the health effects of toxic
substances’’ under CERCLA Section
104(i)(1)(B), to respond to requests for
consultation under section 104(i)(4),
and as otherwise necessary to support
the site-specific response actions
conducted by ATSDR.
For previous versions of the list of
substances, see Federal Register notices
dated April 17, 1987 (52 FR 12866);
October 20, 1988 (53 FR 41280); October
26, 1989 (54 FR 43619); October 17,
1990 (55 FR 42067); October 17, 1991
(56 FR 52166); October 28, 1992 (57 FR
48801); February 28, 1994 (59 FR 9486);
April 29, 1996 (61 FR 18744); November
17, 1997 (62 FR 61332); October 21,
1999 (64 FR 56792); October 25, 2001
(66 FR 54014); November 7, 2003 (68 FR
63098); and December 7, 2005 (70 FR
72840). [CERCLA also requires that
ATSDR initiate a research program to
fill data needs associated with the
substances.] Section 104(i)(3) of
CERCLA [42 U.S.C. 9604(i)(3)] outlines
the content of these profiles. Each
profile will include an examination, a
summary, and an interpretation of
available toxicological information and
epidemiological evaluations. This
information and these data identify the
levels of significant human exposure for
the substance and for the associated
health effects. The profiles must also
include a determination of whether
adequate information on the health
effects of each substance is available or
is in the process of development. If
adequate information is not available,
ATSDR, in cooperation with the
National Toxicology Program (NTP), is
required to ensure the initiation of
research to determine such health
effects.
Although during the profile
development process ATSDR
considered key studies for each of the
substances, this Federal Register notice
solicits any relevant, additional studies,
particularly unpublished data and
ongoing studies. ATSDR will evaluate
such data or studies for possible
addition to the profiles, now or in the
future.
The following draft toxicological
profiles have been made available to the
public:
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Toxicological profile
1.
2.
3.
4.
CAS Number
Acrylamide ........................
Carbon Monoxide .............
1,3–Butadiene ..................
Phosphate Ester Flame
Retardants .........................
5. Vanadium .........................
79–06–1
630–08–0
106–99–0
78–51–3
126–73–8
126–71–6
115–86–6
13674–84–5
13674–87–8
115–96–8
7440–62–2
All profiles issued as ‘‘Drafts for
Public Comment’’ represent ATSDR’s
best efforts to provide important
toxicological information on priority
hazardous substances. We seek public
comment and additional information
that may supplement these profiles.
ATSDR remains committed to providing
a public comment period for these
documents as the best means to serve
public health and our clients.
Dated: December 4, 2009.
Ken Rose,
Director, Office of Policy, Planning and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. E9–29345 Filed 12–16–09; 8:45 am]
66979
117 N. Welcome Slough Rd., Puget
Island, Cathlamet, WA 98612. The
petition proposes to amend the food
additive regulations in part 172 Food
Additives Permitted for Direct Addition
to Food for Human Consumption (21
CFR part 172) to provide for the safe use
of vitamin D2 bakers yeast as a dual
purpose nutrient supplement and
leavening agent or dough relaxer in
yeast-containing baked products.
The agency has determined under 21
CFR 25.32(k) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
Dated: December 8, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E9–29961 Filed 12–16–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
BILLING CODE 4163–70–P
Health Center Program
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–F–0570]
Lallemand, Inc.; Filing of Food Additive
Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that Lallemand, Inc., has filed a petition
proposing that the food additive
regulations be amended to provide for
the safe use of vitamin D2 bakers yeast
as a dual purpose nutrient supplement
and leavening agent or dough relaxer in
yeast-containing baked products.
FOR FURTHER INFORMATION CONTACT:
Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1071.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 9A4779) has been filed by
Lallemand, Inc., c/o Dennis T. Gordon,
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
AGENCY: Health Resources and Services
Administration, HHS.
ACTION: Notice of noncompetitive
replacement awards to Regional Health
Care Affiliates.
SUMMARY: The Health Resources and
Services Administration (HRSA) will be
transferring Health Center Program
(section 330 of the Public Health Service
Act) New Access Point (NAP) and
Increased Demand for Service (IDS)
funds originally awarded to Trover
Health System to Regional Health Care
Affiliates to ensure the provision of
critical primary health care services to
underserved populations in Webster
and McLean Counties, Kentucky.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: Trover
Health System.
Original Period of Grant Support:
March 1, 2009 to February 28, 2011
(NAP) and March 27, 2009 to March 26,
2011 (IDS).
Replacement Awardee: Regional
Health Care Affiliates.
Amount of Replacement Awards:
$1,300,000 (NAP) and $101,000 (IDS).
Period of Replacement Awards: The
period of support for the replacement
awards is March 1, 2009, to February 28,
2011 (NAP) and March 27, 2009, to
March 26, 2009 (IDS).
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66980
Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Notices
Authority: Section 330 of the Public
Health Service Act, 42 U.S.C. 245b.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
CFDA Number: 93.703.
Food and Drug Administration
Justification for the Exception to
Competition
[Docket No. FDA–2009–D–0573]
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Under the original grant applications
approved by HRSA, Regional Health
Care Affiliates (RHCA) was identified as
the provider of health care services on
behalf of the Trover Health System,
while Trover Health System was to
serve in an administrative capacity for
the grants. After the awards were issued,
Trover Health System and RHCA
notified HRSA that RHCA’s
organizational structure had changed to
enable it to carry out both
administrative and programmatic
requirements. The two parties requested
that full responsibility for the grants be
transferred from Trover Health System
to RHCA. RHCA provided
documentation that it meets Section 330
statutory and regulatory requirements as
well as applicable grant management
requirements.
Regional Health Care Affiliates will
directly initiate primary health care
services in Webster and McLean
Counties to the more than 5,250 low
income, underserved and uninsured
individuals in the original service area,
Webster and McLean Counties, KY, as
had been proposed in funded grant
applications.
Regional Health Care Affiliates can
provide primary health care services
immediately, is located in the same
geographical area where the Trover
Health System’s primary health care
services have been provided, and will
be able to provide continuity of care to
patients of the former grantee.
This underserved target population
has an immediate need for vital primary
health care services and would be
negatively impacted by any delay
caused by a competition. As a result, in
order to ensure that critical primary
health care services are available to the
original target population in a timely
manner, these replacement awards will
not be competed.
FOR FURTHER INFORMATION CONTACT:
Marquita Cullom-Stott via e-mail at
MCullom-Stott@hrsa.gov or 301–594–
4300.
Dated: December 10, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9–30010 Filed 12–16–09; 8:45 am]
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International Conference on
Harmonisation; Draft Guidance on
Addendum to International Conference
on Harmonisation S6; Preclinical
Safety Evaluation of BiotechnologyDerived Pharmaceuticals S6(R1);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Addendum to ICH S6: Preclinical
Safety Evaluation of BiotechnologyDerived Pharmaceuticals S6(R1).’’ The
draft guidance was prepared under the
auspices of the International Conference
on Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The draft guidance provides
recommendations on nonclinical
studies to support the safety of clinical
trials and marketing applications for
biotechnology-derived pharmaceuticals.
The draft guidance is intended to clarify
and provide greater detail to the
nonclinical recommendations in the
ICH guidance entitled ‘‘S6 Preclinical
Safety Evaluation of BiotechnologyDerived Pharmaceuticals’’ (ICH S6)
published in the Federal Register of
November 18, 1997 (62 FR 61515).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
electronic or written comments on the
draft guidance by February 1, 2010.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
written requests for single copies of the
draft 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; or the Office of
Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
(CBER), Food and Drug Administration,
1401 Rockville Pike, Rockville, MD
20852–1448. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. Send
two self-addressed adhesive labels to
assist the office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Anne M.
Pilaro, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 2324,
Silver Spring, MD 20993–0002,
301–796–2320; or Mercedes A.
Serabian, Center for Biologics
Evaluation and Research (HFM–
760), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
827–5377.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
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]]>Agencies
[Federal Register Volume 74, Number 241 (Thursday, December 17, 2009)]
[Notices]
[Pages 66979-66980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30010]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Health Center Program
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice of noncompetitive replacement awards to Regional Health
Care Affiliates.
-----------------------------------------------------------------------
SUMMARY: The Health Resources and Services Administration (HRSA) will
be transferring Health Center Program (section 330 of the Public Health
Service Act) New Access Point (NAP) and Increased Demand for Service
(IDS) funds originally awarded to Trover Health System to Regional
Health Care Affiliates to ensure the provision of critical primary
health care services to underserved populations in Webster and McLean
Counties, Kentucky.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: Trover Health System.
Original Period of Grant Support: March 1, 2009 to February 28,
2011 (NAP) and March 27, 2009 to March 26, 2011 (IDS).
Replacement Awardee: Regional Health Care Affiliates.
Amount of Replacement Awards: $1,300,000 (NAP) and $101,000 (IDS).
Period of Replacement Awards: The period of support for the
replacement awards is March 1, 2009, to February 28, 2011 (NAP) and
March 27, 2009, to March 26, 2009 (IDS).
[[Page 66980]]
Authority: Section 330 of the Public Health Service Act, 42
U.S.C. 245b.
CFDA Number: 93.703.
Justification for the Exception to Competition
Under the original grant applications approved by HRSA, Regional
Health Care Affiliates (RHCA) was identified as the provider of health
care services on behalf of the Trover Health System, while Trover
Health System was to serve in an administrative capacity for the
grants. After the awards were issued, Trover Health System and RHCA
notified HRSA that RHCA's organizational structure had changed to
enable it to carry out both administrative and programmatic
requirements. The two parties requested that full responsibility for
the grants be transferred from Trover Health System to RHCA. RHCA
provided documentation that it meets Section 330 statutory and
regulatory requirements as well as applicable grant management
requirements.
Regional Health Care Affiliates will directly initiate primary
health care services in Webster and McLean Counties to the more than
5,250 low income, underserved and uninsured individuals in the original
service area, Webster and McLean Counties, KY, as had been proposed in
funded grant applications.
Regional Health Care Affiliates can provide primary health care
services immediately, is located in the same geographical area where
the Trover Health System's primary health care services have been
provided, and will be able to provide continuity of care to patients of
the former grantee.
This underserved target population has an immediate need for vital
primary health care services and would be negatively impacted by any
delay caused by a competition. As a result, in order to ensure that
critical primary health care services are available to the original
target population in a timely manner, these replacement awards will not
be competed.
FOR FURTHER INFORMATION CONTACT: Marquita Cullom-Stott via e-mail at
MCullom-Stott@hrsa.gov or 301-594-4300.
Dated: December 10, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9-30010 Filed 12-16-09; 8:45 am]
BILLING CODE 4165-15-P
