Agency Information Collection Activities: Submission for OMB Review; Comment Request, 20993-20994 [2011-9077]
Download as PDF
<![CDATA[
20993
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
comments that are received in response
to this notice to determine whether to
amend the guidance document.
II. Significance of Guidance
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 low level laser
systems for aesthetic use. 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 requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by using the
Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Class II Special Controls
Guidance Document: Low Level Laser
System for Aesthetic Use,’’ you may
either send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1735 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E, have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 820 have
been approved under OMB control
number 0910–0073; and the collections
of information in 21 CFR 801 have been
approved under OMB control number
0910–0485.
V. 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.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8945 Filed 4–13–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Sickle Cell Disease
Program Evaluations and Quality
Improvement Activities—[NEW]
The Sickle Cell Disease and Newborn
Screening Program (SCDNBSP) and the
Sickle Cell Disease Treatment
Demonstration Program (SCDTDP) are
both administered by the Genetic
Services Branch (GSB) of the Division of
Services for Children with Special
Health Needs in the Health Resources
and Services Administration’s (HRSA)
Maternal and Child Health Bureau
(MCHB). The SCDTDP is comprised of
geographically distributed regional
networks that provide coordinated,
comprehensive, culturally competent,
and family-centered care to families
with sickle cell disease and a national
coordinating center to support grantee
activities. The SCDTDP is designed to
improve access to services for
individuals with sickle cell disease,
improve/expand patient and provider
education, and improve/expand the
continuity and coordination of service
delivery for individuals with sickle cell
disease and carriers of the sickle cell
gene mutation. The SCDNBSP is
comprised of several national funded
community-based sickle cell disease
networks located in the U.S. and the
National Coordinating and Evaluation
Center. The community-based sickle
cell disease networks partner with State
newborn screening programs,
comprehensive sickle cell treatment
centers, and health care professionals to
provide support to infants screened
positive for sickle cell disease, carriers
of the sickle cell gene mutation and
their families.
HRSA seeks to conduct two
evaluations (SCDTDP evaluation
previously approved by OMB) and a
quality improvement project, the
purpose of which are to assess the
service delivery processes and outcomes
resulting from the systems of care
delivered by the SCDNBSP and SCDTDP
networks to individuals affected by
sickle cell disease who present at their
sites for care. The clients of the three
programs will be the respondents for
this data collection activity.
The annual estimate of burden for
both the SCDNBSP and the SCDTDP
evaluations and quality improvement
effort is as follows:
ESTIMATED HOUR AND COST BURDEN OF THE DATA COLLECTION
mstockstill on DSKH9S0YB1PROD with NOTICES
Questionnaires
Number of
respondents
MDP SCD Questionnaire ........................
MDP SCT Questionnaire ........................
Utilization Questionnaire (pre-demonstration) ...............
VerDate Mar<15>2010
18:34 Apr 13, 2011
Responses
per
respondent
Total
responses
Average hours
per response
Total hour
burden
Wage rate
Total hour cost
140
2
280
.45
126
$20.90
$2633.4
1400
1
1400
.30
420
20.90
8778
900
1
900
.75
675
20.90
14,107.5
Jkt 223001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
E:\FR\FM\14APN1.SGM
14APN1
20994
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
ESTIMATED HOUR AND COST BURDEN OF THE DATA COLLECTION—Continued
Questionnaires
Number of
respondents
Utilization Questionnaire (post demonstration) ...............
SF–36 Health Survey
for adults over 18
years of age ...........
PedsQL for parents of
children & adolescents 18 years or
younger ...................
PedsQL for children &
adolescents 18
years or younger ....
The Medical Home
Family Index
(Health Care Satisfaction) ....................
QI Instrument .............
Hemoglobinopathies
Emerging Populations Form ............
(Client Family Communication) .............
Total ....................
Responses
per
respondent
Wage rate
Total hour cost
900
.50
450
20.90
9,405
630
2
1260
.25
315
20.90
6,583.5
270
2
540
.25
135
20.90
2,821.5
225
2
450
.25
112.5
20.90
2,351.25
900
9
2
12
1800
108
.25
450
432
20.90
20.90
9,405
9,028.80
900
2
1800
.20
360
20.90
7,524
6,274
........................
9,438
..........................
3,475.5
........................
72,637.95
[FR Doc. 2011–9077 Filed 4–13–11; 8:45 am]
BILLING CODE 4165–15–P
Health Resources and Services
Administration
Privacy Act of 1974; Deletion of an
Existing System of Records
Department of Health and
Human Services (HHS), Health
Resources and Services Administration
(HRSA).
ACTION: Notice to delete an existing
HRSA system of records (SOR).
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
HRSA is deleting an existing system of
records titled Record of Patient’s
Personal Valuables and Monies, HRSA
SOR #09–15–0002, established at Vol.
SUMMARY:
Jkt 223001
4
59, No. 61 Federal Register pp 6854–6,
December 28, 1994.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Effective Date: The deletion will
be effective on April 14, 2011.
Substance Abuse and Mental Health
Services Administration
DATES:
The public should address
comments to Associate Administrator,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 17–105, Rockville, Maryland
20857, Telephone number 301–594–
4110. Comments received will be
available for review at this location, by
appointment, during regular business
hours, Monday through Friday from
9 a.m. to 3 p.m., Eastern Time Zone.
ADDRESSES:
HRSA’s
Bureau of Primary Health Care’s
National Hansen’s Disease Program
(NHDP) located in Baton Rouge,
Louisiana, formerly leased hospital
space where the elderly Hansen’s
disease resident patients resided. The
purpose of this System of Records was
to provide for the safekeeping of those
residents’ valuables as needed. In
September 2009, when the hospital
lease expired, those Hansen’s disease
residents were relocated to a nursing
home facility; therefore, this system of
records is no longer required.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSKH9S0YB1PROD with NOTICES
Total hour
burden
1
Dated: April 8, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
18:34 Apr 13, 2011
Average hours
per response
900
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
VerDate Mar<15>2010
Total
responses
Dated: March 31, 2011.
Mary K. Wakefield,
Administrator.
[FR Doc. 2011–9112 Filed 4–13–11; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Center for Substance Abuse
Prevention; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given of the Web
conference meeting of the Substance
Abuse and Mental Health Services
Administration’s (SAMHSA) Center for
Substance Abuse Prevention (CSAP)
Drug Testing Advisory Board (DTAB) on
May 3 and 4, 2011.
A portion of the meeting from 10 a.m.
to 5 p.m. EDT on May 3 will be open
to the public and will include the
Federal drug testing updates from the
Department of Transportation, the
Department of Defense, the Nuclear
Regulatory Commission, and the Federal
Drug-Free Workplace Programs; updates
on the electronic custody and control
form and the medical review officer
certification under the Mandatory
Guidelines for Federal Workplace Drug
Testing Programs; and updates on oral
fluid as a potential alternative specimen
for Federal Workplace Drug Testing
Programs.
The public is invited to attend the
open session in person or to listen via
teleconference. Due to the limited
seating space and call-in capacity,
registration is requested. Public
comments are welcome. To register,
E:\FR\FM\14APN1.SGM
14APN1
]]>Agencies
[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Pages 20993-20994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9077]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: Sickle Cell Disease Program Evaluations and Quality
Improvement Activities--[NEW]
The Sickle Cell Disease and Newborn Screening Program (SCDNBSP) and
the Sickle Cell Disease Treatment Demonstration Program (SCDTDP) are
both administered by the Genetic Services Branch (GSB) of the Division
of Services for Children with Special Health Needs in the Health
Resources and Services Administration's (HRSA) Maternal and Child
Health Bureau (MCHB). The SCDTDP is comprised of geographically
distributed regional networks that provide coordinated, comprehensive,
culturally competent, and family-centered care to families with sickle
cell disease and a national coordinating center to support grantee
activities. The SCDTDP is designed to improve access to services for
individuals with sickle cell disease, improve/expand patient and
provider education, and improve/expand the continuity and coordination
of service delivery for individuals with sickle cell disease and
carriers of the sickle cell gene mutation. The SCDNBSP is comprised of
several national funded community-based sickle cell disease networks
located in the U.S. and the National Coordinating and Evaluation
Center. The community-based sickle cell disease networks partner with
State newborn screening programs, comprehensive sickle cell treatment
centers, and health care professionals to provide support to infants
screened positive for sickle cell disease, carriers of the sickle cell
gene mutation and their families.
HRSA seeks to conduct two evaluations (SCDTDP evaluation previously
approved by OMB) and a quality improvement project, the purpose of
which are to assess the service delivery processes and outcomes
resulting from the systems of care delivered by the SCDNBSP and SCDTDP
networks to individuals affected by sickle cell disease who present at
their sites for care. The clients of the three programs will be the
respondents for this data collection activity.
The annual estimate of burden for both the SCDNBSP and the SCDTDP
evaluations and quality improvement effort is as follows:
Estimated Hour and Cost Burden of the Data Collection
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 $2633.4
MDP SCT Questionnaire................... 1400 1 1400 .30 420 20.90 8778
Utilization Questionnaire (pre- 900 1 900 .75 675 20.90 14,107.5
demonstration).........................
[[Page 20994]]
Utilization Questionnaire (post 900 1 900 .50 450 20.90 9,405
demonstration).........................
SF-36 Health Survey for adults over 18 630 2 1260 .25 315 20.90 6,583.5
years of age...........................
PedsQL for parents of children & 270 2 540 .25 135 20.90 2,821.5
adolescents 18 years or younger........
PedsQL for children & adolescents 18 225 2 450 .25 112.5 20.90 2,351.25
years or younger.......................
The Medical Home Family Index (Health 900 2 1800 .25 450 20.90 9,405
Care Satisfaction).....................
QI Instrument........................... 9 12 108 4 432 20.90 9,028.80
Hemoglobinopathies Emerging Populations 900 2 1800 .20 360 20.90 7,524
Form...................................
(Client Family Communication)...........
---------------------------------------------------------------------------------------------------------------
Total............................... 6,274 .............. 9,438 .............. 3,475.5 .............. 72,637.95
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: April 8, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-9077 Filed 4-13-11; 8:45 am]
BILLING CODE 4165-15-P
