Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Loan Repayment Program, 29520-29521 [E8-11184]
Download as PDF
29520
Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Notices
electronic comments to https://
www.regulations.gov.
Paul
E. Levine, 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:
FOR FURTHER INFORMATION CONTACT:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Requalification Method for
Reentry of Blood Donors Deferred
Because of Reactive Test Results for
Antibody to Hepatitis B Core Antigen
(Anti-HBc)’’ dated May 2008. FDA is
providing recommendations to
establishments that collect human blood
or blood components for a
requalification method or process for
the reentry of deferred donors into the
donor pool based on a determination
that previous tests that were repeatedly
reactive for anti-HBc were falsely
positive and that there is no evidence of
infection with HBV. Due to the
availability of this licensed HBV nucleic
acid test and the improved specificity of
anti-HBc assays, we are recommending
a reentry algorithm for donors deferred
due to a falsely positive repeatedly
reactive test for anti-HBc in this
guidance. Until now FDA has not
recommended a requalification method
or process for reentry of donors deferred
due to reactive test results for hepatitis
B core antigen (anti-HBc) due to the lack
of licensed tests that could be
recommended for use in a suitable
algorithm for this purpose.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent 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.
cprice-sewell on PROD1PC69 with NOTICES
II. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
VerDate Aug<31>2005
15:18 May 20, 2008
Jkt 214001
with the docket number found in the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
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 cassia gum as a stabilizer in frozen
dairy desserts, and to improve texture
and water retention in cheeses, meat
products, and poultry 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.
III. Electronic Access
Dated: May 13, 2008.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E8–11279 Filed 5–20–08; 8:45 am]
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.regulations.gov.
Dated: May 12, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–11433 Filed 5–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
Indian Health Service
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service Loan Repayment
Program
Food and Drug Administration
AGENCY:
[Docket No. FDA–2008–F–0290]
ACTION:
Lubrizol Advanced Materials, Inc.;
Filing of Food Additive Petition
SUMMARY: In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, which requires
60 days for public comment on
proposed information collection
projects, the Indian Health Service (IHS)
is publishing for comment a summary of
a proposed information collection to be
submitted to the Office of Management
and Budget (OMB) for review.
Proposed Collection: Title: 0917–
0014, ‘‘Indian Health Service Loan
Repayment Program.’’ Type of
Information Collection Request:
Extension, without revision, of currently
approved information collection, 0917–
0014, ‘‘Indian Health Service Loan
Repayment Program.’’ Form(s): The IHS
Loan Repayment Program Information
Booklet contains the instructions and
the application formats. Need and Use
of Information Collection: The IHS Loan
Repayment Program (LRP) identifies
health professionals with pre-existing
financial obligations for education
expenses that meet program criteria and
who are qualified and willing to serve
at, often remote, IHS health care
facilities. Under the program, eligible
health professionals sign a contract
under which the IHS agrees to repay
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that Lubrizol Advanced Materials, Inc.,
has filed a petition proposing that the
food additive regulations be amended to
provide for the safe use of cassia gum
as a stabilizer in frozen dairy desserts,
and to improve texture and water
retention in cheeses, meat products, and
poultry products.
FOR FURTHER INFORMATION CONTACT:
Raphael A. Davy, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy, College Park, MD 20740–
3835, 301–436–1272.
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 8A4772) has been filed by
Lubrizol Advanced Materials, Inc., c/o
Keller & Heckman LLP, 1001 G St., NW.,
suite 500 West, Washington, DC 20001.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
E:\FR\FM\21MYN1.SGM
Indian Health Service, HHS.
Notice.
21MYN1
29521
Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Notices
part or all of their indebtedness for
professional training time in IHS health
care facilities. This program is necessary
to augment the critically low health
professional staff at IHS health care
facilities.
Any health professional wishing to
have their health education loans repaid
may apply to the IHS Loan Repayment
Program. A two-year contract obligation
is signed by both parties, and the
individual agrees to work at an IHS
location and provide health services to
Native American and Alaska Native
individuals.
The information collected from
individuals is analyzed and a score is
given to each applicant. This score will
determine which applicants will be
awarded each fiscal year. The
administrative scoring system assigns a
score to the geographic location
according to vacancy rates for that fiscal
year and also considers whether the
location is in an isolated area. When an
applicant takes employment at a
location, they in turn ‘‘pick-up’’ the
score of that location. Affected Public:
Individuals and households. Type of
Respondents: Individuals.
The table below provides: Types of
data collection instruments, Estimated
number of respondents, Number of
responses per respondent, Annual
number of responses, Average burden
hour per response, and Total annual
burden hour(s).
ESTIMATED BURDEN HOURS
Estimated
number of
respondents
Data collection instrument
510
510
510
510
510
2,000
Total ..........................................................................................................
cprice-sewell on PROD1PC69 with NOTICES
Section I ...........................................................................................................
Section II ..........................................................................................................
Section III .........................................................................................................
Contract ...........................................................................................................
Affidavit ............................................................................................................
Lender’s Certification .......................................................................................
Responses
per
respondent
Average
burden hour
per response
4,650
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
Request for Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimates are logical; (e) ways to
enhance the quality, utility, and clarity
of the information being collected; and
(f) ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Send Comments and Requests for
Further Information: Send your written
comments, requests for more
information on the proposed collection,
or requests to obtain a copy of the data
collection instrument(s) and
instructions to: Ms. Chria Rouleau, IHS
Reports Clearance Officer, 801
Thompson Avenue, TMP 450, Rockville,
MD 20852–1627; call non-toll free (301)
443–5938; send via facsimile to (301)
594–0899; or send your e-mail requests,
comments, and return address to:
Christina.Rouleau@ihs.gov.
VerDate Aug<31>2005
15:18 May 20, 2008
Jkt 214001
Comment Due Date: Your comments
regarding this information collection are
best assured of having full effect if
received within 60 days of the date of
this publication.
Dated: May 13, 2008.
Robert G. McSwain,
Director, Indian Health Service.
[FR Doc. E8–11184 Filed 5–20–08; 8:45 am]
BILLING CODE 4165–16–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: 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
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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
1
1
4
1
1
18/60
30/60
15/60
20/60
10/60
15/60
Total annual
burden hours
153.0
255.0
128.0
170.0
85.0
500.0
1,282.0
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.
Synthetic Analogs of Juxtamembrane
Domain of IGF–1 Receptor as AntiCancer Agents
Description of Technology: Insulinlike growth factor receptor type one
(IGF–1R), part of the receptor tyrosine
kinase (RTKs) family, is integral to
cancer cell growth and metastasis.
Juxtamembrane domains (JM) of RTKs
are located in the cytoplasm between
the transmembrane and kinase domains.
JMs play a crucial role in the inhibition
of the regulation of receptor activity.
Studies on other small molecules
tyrosine kinase inhibitors (TKIs)
indicate non-specific binding with the
insulin receptor which has high
homology with IGF–1R.
The current invention describes
synthetic analogs of IGF–1R JM which
were found to be potent inhibitors of
IGF–1–mediated cell signaling and
cancer cell growth. These analogs
provide more binding specificity with
less likelihood of significant toxic
effects.
Applications and Modality:
New inhibitors can be used to treat
many types of tumors.
E:\FR\FM\21MYN1.SGM
21MYN1
Agencies
[Federal Register Volume 73, Number 99 (Wednesday, May 21, 2008)]
[Notices]
[Pages 29520-29521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11184]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day Proposed Information
Collection: Indian Health Service Loan Repayment Program
AGENCY: Indian Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, which requires 60 days for public comment on
proposed information collection projects, the Indian Health Service
(IHS) is publishing for comment a summary of a proposed information
collection to be submitted to the Office of Management and Budget (OMB)
for review.
Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan
Repayment Program.'' Type of Information Collection Request: Extension,
without revision, of currently approved information collection, 0917-
0014, ``Indian Health Service Loan Repayment Program.'' Form(s): The
IHS Loan Repayment Program Information Booklet contains the
instructions and the application formats. Need and Use of Information
Collection: The IHS Loan Repayment Program (LRP) identifies health
professionals with pre-existing financial obligations for education
expenses that meet program criteria and who are qualified and willing
to serve at, often remote, IHS health care facilities. Under the
program, eligible health professionals sign a contract under which the
IHS agrees to repay
[[Page 29521]]
part or all of their indebtedness for professional training time in IHS
health care facilities. This program is necessary to augment the
critically low health professional staff at IHS health care facilities.
Any health professional wishing to have their health education
loans repaid may apply to the IHS Loan Repayment Program. A two-year
contract obligation is signed by both parties, and the individual
agrees to work at an IHS location and provide health services to Native
American and Alaska Native individuals.
The information collected from individuals is analyzed and a score
is given to each applicant. This score will determine which applicants
will be awarded each fiscal year. The administrative scoring system
assigns a score to the geographic location according to vacancy rates
for that fiscal year and also considers whether the location is in an
isolated area. When an applicant takes employment at a location, they
in turn ``pick-up'' the score of that location. Affected Public:
Individuals and households. Type of Respondents: Individuals.
The table below provides: Types of data collection instruments,
Estimated number of respondents, Number of responses per respondent,
Annual number of responses, Average burden hour per response, and Total
annual burden hour(s).
Estimated Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Average
Data collection instrument number of Responses per burden hour Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Section I....................................... 510 1 18/60 153.0
Section II...................................... 510 1 30/60 255.0
Section III..................................... 510 4 15/60 128.0
Contract........................................ 510 1 20/60 170.0
Affidavit....................................... 510 1 10/60 85.0
Lender's Certification.......................... 2,000 .............. 15/60 500.0
---------------------------------------------------------------
Total....................................... 4,650 .............. .............. 1,282.0
----------------------------------------------------------------------------------------------------------------
There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
Request for Comments: Your written comments and/or suggestions are
invited on one or more of the following points: (a) Whether the
information collection activity is necessary to carry out an agency
function; (b) whether the agency processes the information collected in
a useful and timely fashion; (c) the accuracy of public burden estimate
(the estimated amount of time needed for individual respondents to
provide the requested information); (d) whether the methodology and
assumptions used to determine the estimates are logical; (e) ways to
enhance the quality, utility, and clarity of the information being
collected; and (f) ways to minimize the public burden through the use
of automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology.
Send Comments and Requests for Further Information: Send your
written comments, requests for more information on the proposed
collection, or requests to obtain a copy of the data collection
instrument(s) and instructions to: Ms. Chria Rouleau, IHS Reports
Clearance Officer, 801 Thompson Avenue, TMP 450, Rockville, MD 20852-
1627; call non-toll free (301) 443-5938; send via facsimile to (301)
594-0899; or send your e-mail requests, comments, and return address
to: Christina.Rouleau@ihs.gov.
Comment Due Date: Your comments regarding this information
collection are best assured of having full effect if received within 60
days of the date of this publication.
Dated: May 13, 2008.
Robert G. McSwain,
Director, Indian Health Service.
[FR Doc. E8-11184 Filed 5-20-08; 8:45 am]
BILLING CODE 4165-16-M