Agency Information Collection Activities: Proposed Collection: Comment Request, 52533-52534 [2010-21220]
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Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices
the meeting. Members of the public will
have the opportunity to provide
comments at the meeting. Public
comment will be limited to five minutes
per speaker. Individuals who would like
to submit written statements should
e-mail or fax their comments to the
National Vaccine Program Office at least
five business days prior to the meeting.
Those wishing to register to attend the
meeting may do so by sending an e-mail
to nvpo@hhs.gov or by calling 202–690–
5566 and providing name, e-mail
address and organization.
Dated: August 23, 2010.
Bruce Gellin,
Deputy Assistant Secretary for Health,
Director, National Vaccine Program Office.
[FR Doc. 2010–21263 Filed 8–25–10; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
Department of Health and
Human Services, Office of Public Health
and Science, The Presidential
Commission for the Study of Bioethical
Issues.
ACTION: Notice of meeting.
AGENCY:
The Presidential Commission
for the Study of Bioethical Issues will
conduct a meeting in September. At this
meeting, the Commission will continue
discussing the emerging science of
synthetic biology, including its potential
benefits and risks, and appropriate
ethical boundaries and principles.
DATES: The meeting will take place
Monday, September 13, 2010, from 8:50
a.m. to approximately 4:15 p.m., and
Tuesday, September 14, 2010, from 9
a.m. to approximately noon.
ADDRESSES: Monday, September 13, The
Inn at Penn, 3600 Sansom Street,
Philadelphia, PA 19104. Phone 215–
222–0200. Tuesday, September 14, The
Annenberg Public Policy Center, 202
South 36th Street, Philadelphia, PA
19104. Phone 215–898–9400.
FOR FURTHER INFORMATION CONTACT: Ms.
Diane M. Gianelli, Director of
Communications, The Presidential
Commission for the Study of Bioethical
Issues, 1425 New York Avenue, NW.,
Suite C–100, Washington, DC 20005.
Telephone: 202/233–3960. E-mail:
info@bioethics.gov. Additional
information may be obtained by viewing
the Web site: https://www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act,
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SUMMARY:
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Public Law 92–463, 5 U.S.C. App.,
notice is hereby given that the
Presidential Commission for the Study
of Bioethical Issues (PCSBI) will be
conducting a meeting. The meeting will
be held from 8:50 a.m. to approximately
4:15 p.m. on Monday, September 13,
2010, at the Inn at Penn, 3600 Sansom
Street, Philadelphia, PA 19104, and
from 9 a.m. to approximately noon on
Tuesday, September 14, 2010, at The
Annenberg Public Policy Center, 202
South 36th Street, Philadelphia, PA
19104. The meeting will be open to the
public with attendance limited to space
available. The meeting will also be Web
cast.
Under authority of Executive Order
13521, dated November 24, 2009, the
President established the PCSBI to serve
as a public forum and advise him on
bioethical issues generated by novel and
emerging research in biomedicine and
related areas of science and technology.
The Commission is charged to identify
and promote policies and practices that
assure ethically responsible conduct of
scientific research, healthcare delivery,
and technological innovation. In
undertaking these duties, the
Commission will examine specific
bioethical, legal, and social issues
related to potential scientific and
technological advances; examine
diverse perspectives and possibilities
for useful international collaboration on
these issues, and recommend legal,
regulatory, or policy actions as
appropriate. The main agenda items for
this meeting involve further discussion
of the opportunities and benefits to the
public of the emerging science of
synthetic biology, the challenges and
risks, and the ethical boundaries that
may be important to formulation of
public policy with regard to this
advancing science. The Commission
also will hear more from the perspective
of faith communities and others. The
draft meeting agenda and other
information about PCSBI, including
information about access to the Web
cast, will be available at https://
www.bioethics.gov.
The Commission welcomes input
from anyone wishing to provide public
comment on any issue before it.
Individuals who would like to provide
public comment at the meeting should
notify Ms. Diane Gianelli, Director of
Communications, by telephone at 202–
233–3960, or e-mail at
diane.gianelli@bioethics.gov. Anyone
planning to attend the meeting who
needs special assistance, such as sign
language interpretation or other
reasonable accommodations, should
also notify Ms. Gianelli in advance of
the meeting. The Commission will make
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52533
every effort to accommodate persons
who need special assistance.
Written comments will also be
accepted in accord with the
Commission’s existing request for
public comment on the issues before the
Commission. Please address written
comments by e-mail to
info@bioethics.gov, or by mail to the
following address: Public Commentary,
The Presidential Commission for the
Study of Bioethical Issues, 1425 New
York Ave., NW., Suite C–100,
Washington, DC 20005. Comments will
be publicly available, including any
personally identifiable or confidential
business information that they contain.
Trade secrets should not be submitted.
Dated: August 17, 2010.
Valerie H. Bonham,
Executive Director, The Presidential
Commission for the Study of Bioethical Issues.
[FR Doc. 2010–21267 Filed 8–25–10; 8:45 am]
BILLING CODE 4154–06–P
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, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
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, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (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.
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52534
Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices
Proposed Project: Sickle Cell Disease
and Other Hemoglobinopathies
Program Evaluation—[NEW]
Background: In response to the
growing need for resources devoted to
sickle cell disease and other
hemoglobinopathies, Congress, under
Section 501(a)2 of the Social Security
Act (2000), authorized the appropriation
of funds for enabling the Secretary to
provide for special projects of regional
and national significance, research and
training with respect to maternal and
child health and children with special
health care needs the following: Genetic
disease testing, counseling and
information development and
dissemination programs, for grants
relating to hemophilia without regard to
age, and for the screening of newborns
for sickle cell anemia and other genetic
disorders, and follow-up services. As
stated in House Report No. 107–229
regarding the Department of Labor,
Health and Human Services, and
Education, and Related Agencies
Appropriation Bill 2002, the purpose of
the Sickle Cell Disease and Newborn
Screening Program (SCDNBSP) is ‘‘to
enhance the sickle cell disease newborn
screening program and its locally based
outreach and counseling efforts.’’ In
addition, the American Jobs Creation
Act of 2004, Public Law 108–357, states
that ‘‘* * * the Bureau of Primary
Health Care and the Maternal and Child
Health Bureau, shall conduct a
demonstration program by making
grants for up to 40 eligible entities, for
each fiscal year in which the program is
conducted under this section, for the
purpose of developing and establishing
systemic mechanisms to improve the
Questionnaires
prevention and treatment of Sickle Cell
Disease.’’ (See 42 U.S.C. 300b–1).
Purpose: HRSA’s activities under the
legislative authorities relative to the
Sickle Cell Disease and Newborn
Screening Program (SCDNBSP) have
been delegated to the Maternal and
Child Health Bureau (MCHB), Genetic
Services Branch (GSB). The MCHB’s
GSB supports seventeen community
based organizations and the National
Coordinating and Evaluation Center for
the Sickle Cell Disease and Newborn
Screening Program (SCDNBS) in
addition to nine cooperative agreements
and a National Coordinating Center for
the Sickle Cell Disease Treatment
Demonstration Program (SCDTDP). An
evaluation will be conducted to assess
the service delivery processes and
quality of the system of care delivered
by grantees under the Newborn
Screening Program to individuals
affected by Sickle Cell disease who
present at their sites for care. The
Centers for Disease Control and
Prevention defines Hemoglobinopathies
as ‘‘a group of disorders affecting red
blood cells. SCD and Thalassemia are
included in this group.’’ (See https://
www.cdc.gov/ncbddd/sicklecell/
RuSH_FAQs.html). The information
from the evaluation will be used to
evaluate the grantees’ performance in
achieving the objectives of the
hemoglobinopathies program during the
grant period, assess the breadth of
grantees’ outreach to emerging
populations affected by
hemoglobinopathies and the needs of
those populations attempting to access
services. Data collection tools for which
OMB approval is being requested are as
Responses
per
respondent
Number of
respondents
Total
responses
follows: (1) The Minimum Database
Project Sickle Cell Disease (MDP SCD)
Questionnaire, (2) the Minimum
Database Project Sickle Cell Trait/
Carrier (MDP SCT) Questionnaire, and
(3) the MDP Hemoglobinopathies
Emerging Populations Questionnaire.
Respondents: The MDP SCD and the
MDP SCT Questionnaires will be
administered by grantees to clients or
caregivers when they present for
services. At the time of enrollment,
SCDNBSP participants will be informed
about the data collection and clients
will be asked to participate in either the
SCD questionnaire or the SCT
questionnaire depending on their
disease or carrier status. The program
will enroll participants on a rolling
basis such that new patients will be
added to the program as they present for
services and provide consent. Data will
be collected at two points annually for
the SCD Questionnaire, the first, when
clients and caregivers are enrolled into
the SCDNBS Program and the second, at
follow-up after enrollment. Data will be
collected once annually for the SCT
Questionnaire. The Hemoglobinopathies
Emerging Populations Form serves as a
stand alone form for the other HRSA
hemoglobinopathies programs, with its
content. These questions are also
embedded in the MDT SCD and MDP
SCT questionnaires. The HRSA
hemoglobinopathies programs also plan
to use this questionnaire in developing
educational materials, prioritizing
outreach activities and informing
decisions for future funding requests.
The annual estimate of burden is as
follows:
Average hours
per response
Total hour
burden
Wage rate
Total hour
cost
140
1,400
2
1
280
1,400
.45
.30
126
420
$20.90
20.90
$2,633.40
8,778.00
*1,125
2
*2,250
.20
450
20.90
9,405.00
Total ..................................
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MDP SCD Questionnaire .........
MDP SCT Questionnaire .........
Hemoglobinopathies Emerging
Populations Form .................
2,665
........................
3,930
........................
996
....................
20,816.40
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: August 19, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2010–21220 Filed 8–25–10; 8:45 am]
[Docket No. FDA–2010–N–0213]
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Su Van Ho: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52533-52534]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21220]
-----------------------------------------------------------------------
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, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork 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, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) The proposed collection of information
for the proper performance of the functions of the agency; (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.
[[Page 52534]]
Proposed Project: Sickle Cell Disease and Other Hemoglobinopathies
Program Evaluation--[NEW]
Background: In response to the growing need for resources devoted
to sickle cell disease and other hemoglobinopathies, Congress, under
Section 501(a)2 of the Social Security Act (2000), authorized the
appropriation of funds for enabling the Secretary to provide for
special projects of regional and national significance, research and
training with respect to maternal and child health and children with
special health care needs the following: Genetic disease testing,
counseling and information development and dissemination programs, for
grants relating to hemophilia without regard to age, and for the
screening of newborns for sickle cell anemia and other genetic
disorders, and follow-up services. As stated in House Report No. 107-
229 regarding the Department of Labor, Health and Human Services, and
Education, and Related Agencies Appropriation Bill 2002, the purpose of
the Sickle Cell Disease and Newborn Screening Program (SCDNBSP) is ``to
enhance the sickle cell disease newborn screening program and its
locally based outreach and counseling efforts.'' In addition, the
American Jobs Creation Act of 2004, Public Law 108-357, states that ``*
* * the Bureau of Primary Health Care and the Maternal and Child Health
Bureau, shall conduct a demonstration program by making grants for up
to 40 eligible entities, for each fiscal year in which the program is
conducted under this section, for the purpose of developing and
establishing systemic mechanisms to improve the prevention and
treatment of Sickle Cell Disease.'' (See 42 U.S.C. 300b-1).
Purpose: HRSA's activities under the legislative authorities
relative to the Sickle Cell Disease and Newborn Screening Program
(SCDNBSP) have been delegated to the Maternal and Child Health Bureau
(MCHB), Genetic Services Branch (GSB). The MCHB's GSB supports
seventeen community based organizations and the National Coordinating
and Evaluation Center for the Sickle Cell Disease and Newborn Screening
Program (SCDNBS) in addition to nine cooperative agreements and a
National Coordinating Center for the Sickle Cell Disease Treatment
Demonstration Program (SCDTDP). An evaluation will be conducted to
assess the service delivery processes and quality of the system of care
delivered by grantees under the Newborn Screening Program to
individuals affected by Sickle Cell disease who present at their sites
for care. The Centers for Disease Control and Prevention defines
Hemoglobinopathies as ``a group of disorders affecting red blood cells.
SCD and Thalassemia are included in this group.'' (See https://www.cdc.gov/ncbddd/sicklecell/RuSH_FAQs.html). The information from
the evaluation will be used to evaluate the grantees' performance in
achieving the objectives of the hemoglobinopathies program during the
grant period, assess the breadth of grantees' outreach to emerging
populations affected by hemoglobinopathies and the needs of those
populations attempting to access services. Data collection tools for
which OMB approval is being requested are as follows: (1) The Minimum
Database Project Sickle Cell Disease (MDP SCD) Questionnaire, (2) the
Minimum Database Project Sickle Cell Trait/Carrier (MDP SCT)
Questionnaire, and (3) the MDP Hemoglobinopathies Emerging Populations
Questionnaire.
Respondents: The MDP SCD and the MDP SCT Questionnaires will be
administered by grantees to clients or caregivers when they present for
services. At the time of enrollment, SCDNBSP participants will be
informed about the data collection and clients will be asked to
participate in either the SCD questionnaire or the SCT questionnaire
depending on their disease or carrier status. The program will enroll
participants on a rolling basis such that new patients will be added to
the program as they present for services and provide consent. Data will
be collected at two points annually for the SCD Questionnaire, the
first, when clients and caregivers are enrolled into the SCDNBS Program
and the second, at follow-up after enrollment. Data will be collected
once annually for the SCT Questionnaire. The Hemoglobinopathies
Emerging Populations Form serves as a stand alone form for the other
HRSA hemoglobinopathies programs, with its content. These questions are
also embedded in the MDT SCD and MDP SCT questionnaires. The HRSA
hemoglobinopathies programs also plan to use this questionnaire in
developing educational materials, prioritizing outreach activities and
informing decisions for future funding requests.
The annual estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Average hours Total hour Total hour
Questionnaires respondents respondent responses per response burden Wage rate cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDP SCD Questionnaire............................ 140 2 280 .45 126 $20.90 $2,633.40
MDP SCT Questionnaire............................ 1,400 1 1,400 .30 420 20.90 8,778.00
Hemoglobinopathies Emerging Populations Form..... *1,125 2 *2,250 .20 450 20.90 9,405.00
------------------------------------------------------------------------------------------------------
Total........................................ 2,665 .............. 3,930 .............. 996 ........... 20,816.40
--------------------------------------------------------------------------------------------------------------------------------------------------------
E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 60 days
of this notice.
Dated: August 19, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-21220 Filed 8-25-10; 8:45 am]
BILLING CODE 4165-15-P
