Agency Forms Undergoing Paperwork Reduction Act Review, 52436-52438 [2016-18746]
Download as PDF
52436
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Form name
Medical/Clinical Laboratory Technologist .......
57.307 Hemovigilance Adverse Reaction—
Acute Hemolytic Transfusion Reaction.
57.308 Hemovigilance Adverse Reaction—
Allergic Transfusion Reaction.
57.309 Hemovigilance Adverse Reaction—
Delayed Hemolytic Transfusion Reaction.
57.310 Hemovigilance Adverse Reaction—
Delayed Serologic Transfusion Reaction.
57.311 Hemovigilance Adverse Reaction—
Febrile Non-hemolytic Transfusion Reaction.
57.312 Hemovigilance Adverse Reaction—
Hypotensive Transfusion Reaction.
57.313 Hemovigilance Adverse Reaction—
Infection.
57.314 Hemovigilance Adverse Reaction—
Post Transfusion Purpura.
57.315 Hemovigilance Adverse Reaction—
Transfusion Associated Dyspnea.
57.316 Hemovigilance Adverse Reaction—
Transfusion Associated Graft vs. Host Disease.
57.317 Hemovigilance Adverse Reaction—
Transfusion Related Acute Lung Injury.
57.318 Hemovigilance Adverse Reaction—
Transfusion Associated Circulatory Overload.
57.319 Hemovigilance Adverse Reaction—
Unknown Transfusion Reaction.
57.320 Hemovigilance Adverse Reaction—
Other Transfusion Reaction.
57.400 Patient Safety Component—Annual
Facility Survey for Ambulatory Surgery
Center (ASC).
57.401 Outpatient Procedure Component—
Monthly Reporting Plan.
57.402 Outpatient Procedure Component
Event.
57.403 Outpatient Procedure Component—
Monthly Denominators and Summary.
57.500 Outpatient Dialysis Center Practices
Survey.
57.501 Dialysis Monthly Reporting Plan ........
57.502 Dialysis Event ....................................
57.503 Denominator for Outpatient Dialysis ..
57.504 Prevention Process Measures Monthly Monitoring for Dialysis.
57.505 Dialysis Patient Influenza Vaccination
57.506 Dialysis Patient Influenza Vaccination
Denominator.
57.507 Home Dialysis Center Practices Survey.
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Medical/Clinical Laboratory Technologist .......
Staff RN ..........................................................
Staff RN ..........................................................
Staff RN ..........................................................
Staff RN ..........................................................
Registered Nurse (Infection Preventionist) .....
Staff RN ..........................................................
Staff RN ..........................................................
Staff RN ..........................................................
Staff RN ..........................................................
Staff RN ..........................................................
Staff RN ..........................................................
mstockstill on DSK3G9T082PROD with NOTICES
Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information
Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for
Science, Office of the Director, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–18710 Filed 8–5–16; 8:45 am]
[30Day–16–0010]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Avg. burden
per response
(in hrs.)
500
4
25/60
500
4
25/60
500
1
25/60
500
2
25/60
500
4
25/60
500
1
25/60
500
1
25/60
500
1
25/60
500
1
25/60
500
1
25/60
500
1
25/60
500
2
25/60
500
1
25/60
500
1
25/60
5,000
1
5/60
5,000
12
15/60
5,000
25
40/60
5,000
12
40/60
6,500
1
2.0
6,500
6,500
6,500
1,500
12
60
12
12
5/60
25/60
10/60
1.25
325
325
75
5
10/60
10/60
600
1
25/60
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
E:\FR\FM\08AUN1.SGM
08AUN1
52437
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, Washington, DC 20503 or by fax
to (202) 395–5806. Written comments
should be received within 30 days of
this notice.
Proposed Project
Birth Defects Study To Evaluate
Pregnancy exposureS (BD–STEPS)
(formerly titled The National Birth
Defects Prevention Study (NBDPS)),
(OMB 0920–0010, Expiration 01/31/
2017)—Revision—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and
genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects
currently covering three counties in
Metropolitan Atlanta.
Since 1997, CDC has funded casecontrol studies of major birth defects
that utilize existing birth defect
surveillance registries (including
MACDP) to identify cases and study
birth defects causes in participating
states/municipalities across the United
States.
The current study, BD–STEPS, is a
case-control study that is similar to the
previous CDC-funded birth defects casecontrol study, NBDPS, which stopped
interviewing participants in 2013. As
with NBDPS, BD–STEPS control infants
are randomly selected from birth
certificates or birth hospital records;
mothers of case and control infants are
interviewed using a computer-assisted
telephone interview.
The results from NBDPS have
improved understanding of the causes
of birth defects. Over 200 articles have
been written in professional journals
using the data from NBDPS, and BD–
STEPS data will soon be added to
NBDPS data for analysis. The current
BD–STEPS revision is an addition to the
study population for two BD–STEPS
Centers. Specifically, in these two
Centers mothers of stillbirths without
major birth defects will be added to the
study population for BD–STEPS and
mothers of all stillbirths (with and
without birth defects) and all controls in
these two Centers will be asked to
participate in a supplemental telephone
interview.
The BD–STEPS interview takes
approximately forty-five minutes to
complete (burden estimate includes
both the introductory telephone script/
consent and questionnaire). For five
Centers, a maximum of 275 interviews
are planned per year per center, 200
cases and 75 controls; for the two
Centers participating in additional
stillbirth interviews, 495 interviews are
planned per center, 200 cases with birth
defects, 75 controls, and 220 stillbirths
without birth defects. With seven
centers planned, the maximum
interview burden for all centers
combined would be approximately
1,774 hours. Mothers in five of the
seven BD–STEPS Centers will also be
asked to provide consent for the study
to access previously collected infant
bloodspots. It takes approximately 15
minutes to read, sign and return the
informed consent for retrieval of
bloodspots. For approximately one fifth
of participants, some medical records
review will be conducted. The medical
records release form takes participants
approximately 15 minutes to read, sign
and return. In addition, it takes
approximately 30 minutes for each
medical record reviewer to conduct the
review and send the medical record.
The online questionnaire will be offered
to approximately one third of
participants who report certain
occupations during the telephone
interview; these participants will be
asked to complete additional
occupational questions via a Web site
which will take approximately 20
minutes to answer. In addition, in two
Centers, mothers of stillbirths with and
without birth defects and controls will
be asked to participate in a
supplemental telephone interview that
will take approximately 25 minutes to
complete.
Information gathered from both the
interviews and the Deoxyribonucleic
acid specimens has been and will
continue to be used to study
independent genetic and environmental
factors as well as gene-environment
interactions for a broad range of
carefully classified birth defects.
This request is submitted to revise the
previously estimated burden details and
to request OMB clearance for three
additional years. The total estimated
annual burden hours are 3,034. There
are no costs to the respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Activity
Mothers (interview) .........................................
mstockstill on DSK3G9T082PROD with NOTICES
Respondents
Telephone consent and BD–STEPS questionnaire.
Written consent for bloodspot retrieval ..........
Online Occupational Questionnaire ...............
Written release for medical records review ...
Pulling and sending records ..........................
Telephone consent and supplemental questionnaire.
Mothers (consent for bloodspot retrieval) .......
Mothers (online occupational questionnaire) ..
Mothers (consent for medical records review)
Records reviewers (medical records review)
Mothers of all AR/MA stillbirths and controls
(supplemental telephone interview).
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
E:\FR\FM\08AUN1.SGM
Number of responses per
respondent
Average
burden per
response
(in hours)
2,365
1
45/60
1,375
790
475
475
710
1
1
1
1
1
15/60
20/60
15/60
30/60
25/60
08AUN1
52438
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information
Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for
Science, Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2016–18746 Filed 8–5–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living,
Administration on Aging
Agency Information Collection
Activities; Proposed Collection;
Comment Request; State Annual LongTerm Care Ombudsman Report
Revised Data Collection to the National
Ombudsman Reporting System
Administration for Community
Living, Administration on Aging, HHS.
ACTION: Notice.
AGENCY:
The Administration on
Community Living, Administration on
Aging (ACL/AoA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
relating to the National Ombudsman
Reporting System per 45 CFR part
1324.21 and Older Americans Act Title
VII.
DATES: Submit written or electronic
comments on the collection of
information by October 7, 2016.
ADDRESSES: Submit electronic
comments on the collection of
information to: louise.ryan@acl.hhs.gov.
Submit written comments on the
collection of information to: U.S.
Department of Health and Human
Services: Administration for
Community Living 701 Fifth Avenue,
Suite 1600 M/S RX–33, Seattle, WA
98104, Attention: Louise Ryan.
FOR FURTHER INFORMATION CONTACT:
Louise Ryan by telephone: (206) 615–
2514 or by email: louise.ryan@
acl.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with PRA (44 U.S.C. 3501–
3520), the Administration for
Community Living (ACL, formerly the
Administration for Aging) has submitted
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:23 Aug 05, 2016
Jkt 238001
the following proposed collection of
information to the Office of
Management and Budget (OMB) for
review and clearance. The
Administration for Community Living/
Administration on Aging (ACL/AoA) is
requesting approval from the Office of
Management and Budget (OMB) for data
collection associated with the National
Ombudsman Reporting System (NORS).
The report form and instructions have
been in continuous use, with minor
modifications, since they were first
approved by OMB for the FY 1995
reporting period. This request is for
approval to revise the data collection
tool to enhance ACL’s ability to
understand and report on: LTCO
program operations, experience of longterm care facility residents and to
update to reflect changes in: LTC
Ombudsman program operations and
long-term supports and services
policies, research, and practices. States
will continue to provide the following
data and narrative information in the
report:
1. Numbers and descriptions of cases
filed and complaints made on behalf of
long-term care facility residents to the
statewide ombudsman program;
2. Major issues identified impacting
on the quality of care and life of longterm care facility residents;
3. Statewide program operations; and
4. Ombudsman activities in addition
to complaint investigation.
5. Organizational conflict of interest
reporting as required by 45 CFR part
1324.21.
With respect to the following
collection of information, ACL/AoA
invites comments on: (1) Whether the
proposed collection of information is
necessary for the proper performance of
ACL/AoA’s functions, including
whether the information will have
practical utility; (2) the accuracy of
ACL/AoA’s estimate of the burden of
the proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
when appropriate, and other forms of
information technology.
The proposed data collection tools
may be found on the ACL/AoA Web site
at: https://www.aoa.acl.gov/AoA_
Programs/Elder_Rights/Ombudsman/
index.aspx.
AoA estimates the burden of this
additional collection of information as
follows: Approximately 7780 hours,
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
with 52 state Ombudsman programs
responding annually.
Dated: August 2, 2016.
Edwin L. Walker,
Acting Assistant Secretary for Aging.
[FR Doc. 2016–18736 Filed 8–5–16; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request; the
National Maltreatment Reporting
System
Administration for Community
Living, HHS
ACTION: Notice
AGENCY:
The Administration for
Community Living (formerly the
Administration on Aging (AoA) is
announcing that the proposed collection
of information listed below has been
submitted to the Office of Management
and Budget (OMB) for review and
clearance under the Paperwork
Reduction Act of 1995. The purpose of
this notice is to allow for an additional
30 days of public comment on the
information collection requirements
relating to the National Adult
Maltreatment Reporting System
(NAMRS). The proposed collection of
information tools may be found in the
NAMRS section of the ACL Web site.
DATES: Submit written comments on the
collection of information by September
7, 2016.
ADDRESSES: Submit written comments
on the collection of information to the
Office of Management and Budget,
Office for Information and Regulatory
Affairs, Attention: Desk Officer for ACL
by email: OIRA_submission@
omb.eop.gov or fax: 202.395.6974.
FOR FURTHER INFORMATION CONTACT:
Stephanie Whittier Eliason,
Administration for Community Living,
330 C St. SW., Washington, DC 20201;
email: stephanie.whittiereliason@
acl.hhs.gov; telephone: 202.795.7467.
Copies of available documents
submitted to OMB may be obtained by
contacting Stephanie Whittier Eliason.
SUPPLEMENTARY INFORMATION: In
compliance with PRA (44 U.S.C. 3501–
3520), the Administration for
Community Living (ACL, formerly the
Administration for Aging) has submitted
the following proposed collection of
information to the Office of
Management and Budget (OMB) for
SUMMARY:
E:\FR\FM\08AUN1.SGM
08AUN1
Agencies
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52436-52438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18746]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-0010]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the
[[Page 52437]]
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (b) Evaluate the accuracy of
the agencies estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (c) Enhance the quality, utility, and clarity of the information
to be collected; (d) Minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses; and (e) Assess
information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget,
Washington, DC 20503 or by fax to (202) 395-5806. Written comments
should be received within 30 days of this notice.
Proposed Project
Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS)
(formerly titled The National Birth Defects Prevention Study (NBDPS)),
(OMB 0920-0010, Expiration 01/31/2017)--Revision--National Center on
Birth Defects and Developmental Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC has been monitoring the occurrence of serious birth defects and
genetic diseases in Atlanta since 1967 through the Metropolitan Atlanta
Congenital Defects Program (MACDP). The MACDP is a population-based
surveillance system for birth defects currently covering three counties
in Metropolitan Atlanta.
Since 1997, CDC has funded case-control studies of major birth
defects that utilize existing birth defect surveillance registries
(including MACDP) to identify cases and study birth defects causes in
participating states/municipalities across the United States.
The current study, BD-STEPS, is a case-control study that is
similar to the previous CDC-funded birth defects case-control study,
NBDPS, which stopped interviewing participants in 2013. As with NBDPS,
BD-STEPS control infants are randomly selected from birth certificates
or birth hospital records; mothers of case and control infants are
interviewed using a computer-assisted telephone interview.
The results from NBDPS have improved understanding of the causes of
birth defects. Over 200 articles have been written in professional
journals using the data from NBDPS, and BD-STEPS data will soon be
added to NBDPS data for analysis. The current BD-STEPS revision is an
addition to the study population for two BD-STEPS Centers.
Specifically, in these two Centers mothers of stillbirths without major
birth defects will be added to the study population for BD-STEPS and
mothers of all stillbirths (with and without birth defects) and all
controls in these two Centers will be asked to participate in a
supplemental telephone interview.
The BD-STEPS interview takes approximately forty-five minutes to
complete (burden estimate includes both the introductory telephone
script/consent and questionnaire). For five Centers, a maximum of 275
interviews are planned per year per center, 200 cases and 75 controls;
for the two Centers participating in additional stillbirth interviews,
495 interviews are planned per center, 200 cases with birth defects, 75
controls, and 220 stillbirths without birth defects. With seven centers
planned, the maximum interview burden for all centers combined would be
approximately 1,774 hours. Mothers in five of the seven BD-STEPS
Centers will also be asked to provide consent for the study to access
previously collected infant bloodspots. It takes approximately 15
minutes to read, sign and return the informed consent for retrieval of
bloodspots. For approximately one fifth of participants, some medical
records review will be conducted. The medical records release form
takes participants approximately 15 minutes to read, sign and return.
In addition, it takes approximately 30 minutes for each medical record
reviewer to conduct the review and send the medical record. The online
questionnaire will be offered to approximately one third of
participants who report certain occupations during the telephone
interview; these participants will be asked to complete additional
occupational questions via a Web site which will take approximately 20
minutes to answer. In addition, in two Centers, mothers of stillbirths
with and without birth defects and controls will be asked to
participate in a supplemental telephone interview that will take
approximately 25 minutes to complete.
Information gathered from both the interviews and the
Deoxyribonucleic acid specimens has been and will continue to be used
to study independent genetic and environmental factors as well as gene-
environment interactions for a broad range of carefully classified
birth defects.
This request is submitted to revise the previously estimated burden
details and to request OMB clearance for three additional years. The
total estimated annual burden hours are 3,034. There are no costs to
the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Activity Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Mothers (interview)................... Telephone consent and BD- 2,365 1 45/60
STEPS questionnaire.
Mothers (consent for bloodspot Written consent for 1,375 1 15/60
retrieval). bloodspot retrieval.
Mothers (online occupational Online Occupational 790 1 20/60
questionnaire). Questionnaire.
Mothers (consent for medical records Written release for 475 1 15/60
review). medical records review.
Records reviewers (medical records Pulling and sending 475 1 30/60
review). records.
Mothers of all AR/MA stillbirths and Telephone consent and 710 1 25/60
controls (supplemental telephone supplemental
interview). questionnaire.
----------------------------------------------------------------------------------------------------------------
[[Page 52438]]
Jeffrey M. Zirger,
Health Scientist, Acting Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the Associate Director for
Science, Office of the Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016-18746 Filed 8-5-16; 8:45 am]
BILLING CODE 4163-18-P