Submission for OMB Review; Comment Request, 36785-36786 [2013-14589]
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36785
Federal Register / Vol. 78, No. 118 / Wednesday, June 19, 2013 / Notices
A draft questionnaire is available for
review at https://www.regulations.gov.
NIOSH requests public input on the
content of the questionnaire and
consideration of the following:
(1) Apart from a survey, what
alternative methods should be
considered to gather this information?
(2) What resources are available that
can be used to identify nanomaterial
producers, distributors, end-users, and
R&D laboratories for inclusion in a
sampling frame?
(3) A web-based survey is being
proposed primarily because it is costefficient and can be easy to administer.
Should any other modes (telephone,
mail) be considered?
(4) In small and medium-sized
establishments, who would be the
person best suited to respond to
questions addressing risk management
practices for ENMs?
(5) What should be the maximum
amount of time needed to complete the
survey?
(6) Is benchmarking adherence to safe
use guidelines of value to your
organization?
(7) What guidelines are being used by
your organization to minimize worker
exposure to ENMs?
(8) Are there any questions in the
draft survey that should be excluded?
Are there any questions not included in
the draft survey that should be
included?
FOR FURTHER INFORMATION CONTACT: Jim
Boiano—jboiano@cdc.gov; 513–841–
4246 or Rebecca Tsai—rtsai@cdc.gov;
513–841–4398, NIOSH, 4676 Columbia
Parkway, Mail Stop R17, Cincinnati,
Ohio 45226–1998.
Dated: June 13, 2013.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Administration for Children and
Families
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
Submission for OMB Review;
Comment Request
The meeting announced below
concerns Centers for Disease Control
and Prevention Public Health
Preparedness and Response Research to
Aid Recovery from Hurricane Sandy,
Request for Application (RFA) TP13–
001, initial review.
Correction: The notice was published
in the Federal Register on June 11,
2013, Volume 78, Number 112, Pages
35035—35036. The time, date and place
should read as follows:
Time and Date: 12:00 p.m.–5:00 p.m.
(EST), July 10, 2013 (Closed).
Place: Teleconference.
Contact Person for More Information:
Shoukat Qari, D.V.M., Ph.D., Scientific
Review Officer, CDC, 1600 Clifton Road,
NE., Mailstop K72, Atlanta, Georgia
30333, Telephone: (770) 488–8808.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dana Redford,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2013–14541 Filed 6–18–13; 8:45 am]
BILLING CODE 4163–18–P
Title: National Medical Support
Notice
OMB No.: 0970–0222
Description: The National Medical
Support Notice (NMSN) is a two-part
document that requires information
from State child support enforcement
agencies, employers, and health plan
administrators to assist in enforcing
health care coverage provisions in a
child support order. The Department of
Health and Human Services (DHHS),
Administration for Children and
Families (ACF) developed and
maintains Part A of the NMSN, which
is sent to an obligor’s employer for
completion; the Department of Labor
(DOL) developed and maintains Part B
of the NMSN, which is provided to
health care administrators following
completion of Part A.
DOL revised Part B to conform with
changes to the currently approved Part
A and is seeking a three year approval
from OMB. To avoid burdening the
State child support enforcement
agencies with potential reprogramming
at varying times due to future changes
in either Part A or Part B, ACF is
resubmitting an unchanged information
collection package and requesting an
extension to the current OMB approval
of NMSN Part A to synchronize the
expiration date with NMSN Part B.
Respondents: State child support
enforcement agencies, employers, and
health plan administrators.
[FR Doc. 2013–14564 Filed 6–18–13; 8:45 am]
BILLING CODE 4163–19–P
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
National Medical Support Notice—Part A—Notice To Withhold for Health
Care Coverage .............................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
54
97,775
0.17
897,574.50
Estimated Total Annual Burden
Hours: 897,574.50.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
VerDate Mar<15>2010
17:13 Jun 18, 2013
Jkt 229001
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
E:\FR\FM\19JNN1.SGM
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36786
Federal Register / Vol. 78, No. 118 / Wednesday, June 19, 2013 / Notices
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following:
Office of Management and Budget,
Paperwork Reduction Project, Fax: 202–
395–7285, Email:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–14589 Filed 6–18–13; 8:45 am]
BILLING CODE 4184–01–P
Food and Drug Administration
[Docket No. FDA–2013–N–0012]
Linking Marketplace Heparin Product
Attributes and Manufacturing
Processes to Bioactivity and
Immunogenicity
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of a sole source award to the
University of North Carolina. The goal
of the award is to identify what
component(s) of the complex heparin
mixtures have the propensity to cause
heparin induced thrombocytopenia
(HIT) to improve the safety of heparin
drug products. The FDA seeks to
identify the components of the heparin
mixture that are associated with HIT so
that actions may be taken to reduce
these events and improve patient
outcomes with this widely used drug.
DATES: Important dates are as follows:
1. The application due date is July 15,
2013.
2. The anticipated start date is
August, 2013.
3. The opening date is the date this
announcement is published in the
Federal Register.
4. The expiration date is July 16,
2013.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
Submit the paper
application to: Gladys Melendez at the
Food and Drug Administration, Grants
Management (HFA–500), 5630 Fishers
Lane, Rockville, MD 20857. For more
information, see section III of the
SUPPLEMENTARY INFORMATION section of
this notice.
ADDRESSES:
VerDate Mar<15>2010
17:13 Jun 18, 2013
Jkt 229001
David Keire, Center for Drug Evaluation
and Research, Food and Drug
Administration, 1114 Market St., rm.
1002, St Louis, MO, 63130, 314–539–
3850; or Gladys Melendez, Office of
Acquisition Support and Grant Services,
Food and Drug Administration, 5630
Fishers Lane, Rockville, MD 20857,
301–827–7175, email:
Gladys.bohler@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
contact Gladys.bohler @fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Request for Application: FDA RFA–
13–007
[Catalog of Federal Domestic
Assistance: 93.103]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
FOR FURTHER INFORMATION CONTACT:
A. Background
The goal of this Research Project is to
identify which components of heparin
drug mixtures have the propensity to
cause heparin induced
thrombocytopenia (HIT) in order to
improve the safety profile of this widely
used anticoagulant. Heparin is a
heterogeneous mixture of
polysaccharides of varying length,
sulfation pattern, acylation and
conformation that has been in clinical
use since the 1930s. HIT is a drugdependent immune disorder caused by
antibodies to complexes formed
between platelet factor 4 (PF4) and
heparin which can occur in patients
who undergo major trauma (e.g. broken
bones and cardiovascular surgery) and
receive heparin. The condition leads to
formation of abnormal blood clots and
concomitant complications associated
with clots. PF4-heparin antibodies are
observed in all patients with HIT. In
addition, low molecular weight
heparins or the synthetic
pentasaccharide (fondaparinux) have
also been shown to cause HIT antibody
formation although these smaller chain
length heparins are much less likely to
lead to clinical HIT symptoms.
The major limitation in the available
reagents for studies aimed at identifying
the components of heparin that lead to
the pathogenesis of HIT is the lack of
pure component heparin standards.
Therefore, this collaboration brings
together the following capabilities and
laboratories: (1) Synthesis of heparin
chains of the same length, sulfation
pattern and conformation (Dr. Liu at the
University of North Carolina and Dr.
Linhardt at Rensselaer Polytechnical
Institute), (2) synthesis and
physicochemical characterization of
heparin and heparin-PF4 complexes
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
(Keire FDA/DPA St Louis) and (3) a
HIT-immunogenicity animal model (Dr.
Arepally at Duke University). FDA
believes that this combination of skills
and expertise has the potential to make
pure standards, fully characterize the
standards, create and characterize PF4heparin standard aggregates and assess
their propensity to elicit an immune
response in an animal model. This
research is unique and not otherwise
available. The ability to make pure
heparin standards in gram quantities
and fully characterize their properties is
only available from the Liu and
Linhardt laboratories. Furthermore, Dr.
Arepally’s mouse model of HIT
immunogenicity is not available in any
other laboratory. When completed the
study will identify heparin components
that enhance HIT propensity and which
could potentially be minimized in
heparin manufacturing, leading to safer
heparin drugs with better patient
outcomes.
B. Research Objectives
The research objective is to identify
the components of the heparin mixture
that have the propensity to lead to HIT
pathogenesis.
C. Eligibility Information
This is a sole source RFA because the
investigators identified in this
document have unique skills and
expertise necessary to perform the
proposed work.
II. Award Information/Funds Available
A. Award Amount
Only one award will be available to
the University of North Carolina in the
amount of $250,000 (Total Cost) in the
first year.
B. Length of Support
Depending on research progress and
subject to the availability of funds
additional funds may be awarded under
this grant for up to a five year project
period reflecting $250,000 Total Cost
per year.
III. Paper Application, Registration,
and Submission Information
To submit a paper application in
response to this FOA, applicants should
first review the full announcement.
Persons interested in applying for a
grant may obtain an application at
https://grants.nih.gov/grants/forms.htm.
For all paper application submissions,
the following steps are required:
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With Central
Contractor Registration
E:\FR\FM\19JNN1.SGM
19JNN1
]]>Agencies
[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Pages 36785-36786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14589]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: National Medical Support Notice
OMB No.: 0970-0222
Description: The National Medical Support Notice (NMSN) is a two-
part document that requires information from State child support
enforcement agencies, employers, and health plan administrators to
assist in enforcing health care coverage provisions in a child support
order. The Department of Health and Human Services (DHHS),
Administration for Children and Families (ACF) developed and maintains
Part A of the NMSN, which is sent to an obligor's employer for
completion; the Department of Labor (DOL) developed and maintains Part
B of the NMSN, which is provided to health care administrators
following completion of Part A.
DOL revised Part B to conform with changes to the currently
approved Part A and is seeking a three year approval from OMB. To avoid
burdening the State child support enforcement agencies with potential
reprogramming at varying times due to future changes in either Part A
or Part B, ACF is resubmitting an unchanged information collection
package and requesting an extension to the current OMB approval of NMSN
Part A to synchronize the expiration date with NMSN Part B.
Respondents: State child support enforcement agencies, employers,
and health plan administrators.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
National Medical Support Notice--Part A-- 54 97,775 0.17 897,574.50
Notice To Withhold for Health Care Coverage
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 897,574.50.
Additional Information:
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 370 L'Enfant Promenade, SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All requests should be identified
by the title of the information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect
[[Page 36786]]
if OMB receives it within 30 days of publication. Written comments and
recommendations for the proposed information collection should be sent
directly to the following:
Office of Management and Budget, Paperwork Reduction Project, Fax:
202-395-7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer
for the Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013-14589 Filed 6-18-13; 8:45 am]
BILLING CODE 4184-01-P
