Agency Information Collection Activities; Proposed Collection; Public Comment Request, 34683-34684 [2015-14850]
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34683
Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation.
Reclassification of this device from
class III to class II for the intended use
of routine collection of blood and blood
components relieves manufacturers of
the burden of complying with the
premarket approval requirements of
section 515 of the FD&C Act (21 U.S.C.
360e), and may permit small potential
competitors to enter the marketplace by
reducing the burden. Although the
special control guidance recommends
that manufacturers of these devices file
with FDA an annual report for 3
consecutive years, this would be less
burdensome than the current
postapproval requirements under part
814, subpart E (21 CFR part 814, subpart
E), including the submission of periodic
reports under § 814.84.
Collecting or transfusing facilities and
manufacturers have certain
responsibilities under Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the manufacturer is
responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b)). In addition, manufacturers
of medical devices are required to
submit to FDA individual adverse event
reports of death, serious injury, and
malfunctions (§ 803.50).
In the special control guidance
document, FDA recommends that
manufacturers include in their three
annual reports a summary of adverse
reactions maintained by the collecting
or transfusing facility, or similar reports
of adverse events collected, in addition
to those required under the MDR
regulation. The MedWatch medical
device reporting code instructions
(https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm106737.htm)
contains a comprehensive list of adverse
events associated with device use,
including most of those events that we
recommend summarizing in the annual
report.
In the Federal Register of January 29,
2015 (80 FR 4927), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Reporting activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Annual Report ......................................................................
4
1
4
5
20
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are
approximately four manufacturers of
automated blood cell separator devices.
The estimated average burden per
response is based on the time that the
manufacturers will spend preparing and
submitting the annual report.
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
501(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR,
part 803).
Dated: June 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14889 Filed 6–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Office of the Secretary
[Document Identifier: HHS–OS–0990–new–
30D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
VerDate Sep<11>2014
18:47 Jun 16, 2015
Jkt 235001
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, announces plans
to submit a new Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Comments submitted during the
first public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public on
this ICR during the review and approval
period.
DATES: Comments on the ICR must be
received on or before July 17, 2015.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier HHS–OS–0990–
new–30D for reference. Information
Collection Request Title: Title X
Sustainability Assessment Tool for
Grantees and Service Sites.
Abstract: The Office of Population
Affairs within the Office of the Assistant
Secretary for Health seeks to collect data
SUMMARY:
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
from the Title X centers on efforts
related to (1) assisting individuals in
obtaining health insurance; (2)
partnerships with primary care
providers; (3) availability and use of
electronic health records; (4) monitoring
patient care quality; (5) factors affecting
revenue sources; and (6) the way that
sites conduct analyses to consider the
cost of providing services.
Need and Proposed Use of the
Information: The Title X Family
Planning Program (‘‘Title X program’’ or
‘‘program’’) is the only Federal grant
program dedicated solely to providing
individuals with comprehensive family
planning and related preventive health
services (e.g., screening for breast and
cervical cancer, sexually transmitted
diseases (STDs), and human
immunodeficiency virus [HIV]). By law,
priority is given to persons from lowincome families (Section 1006[c] of Title
X of the Public Health Service Act, 42
U.S.C. 300). The Office of Population
Affairs (OPA) within the Office of the
Assistant Secretary for Health
administers the Title X program.
The American health care system is
experiencing unprecedented levels of
change as a result of the Patient
Protection and Affordable Care Act
(ACA). The exact impact of these health
system changes to Title X centers needs
to be assessed in order to ensure the
E:\FR\FM\17JNN1.SGM
17JNN1
34684
Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
Title X Family Planning Program
[‘‘Population Research and Voluntary
Family Planning Programs’’ (91)], which
was enacted in 1970 as Title X of the
Public Health Service Act (Section 1001
of Title X of the Public Health Service
Act, 42 United States Code [U.S.C.]
300).
resources to Title X centers. Data will be
collected through an online data
collection tool directly from grantees
and from Title X centers.
Likely Respondents: This annual
reporting requirement is service sites
that receive funding (either directly
from OPA or through a sub recipient or
grantee agency) for family planning
services authorized and funded by the
long term sustainability of the Title X
network.
Data collected from this effort will be
used to inform the work of the training
centers so they can better support the
Title X grantees. This data will help
OPA better understand challenges
affecting Title X centers in order to
better work with HHS entities and
national stakeholders to provide
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses per
respondent
Number of
respondents
Average
annualized
burden per
response
(hours)
Annual
total burden
(hours)
Type of respondent
Form name
Grantees ........................
Service Sites ..................
Sustainability Assessment—Grantees ................
Sustainability Assessment—Sites .......................
92
4,168
1
1
0.66
0.66
60.72
2750.88
Total ........................
..............................................................................
4,260
........................
........................
2,811.60
Terry S. Clark,
Asst Information Collection Clearance
Officer.
[FR Doc. 2015–14850 Filed 6–16–15; 8:45 am]
BILLING CODE 4150–48–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Population
Assessment of Tobacco and Health
(PATH) Study—3rd Wave (NIDA)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on February 11,
2015, pages 7619–7620 and allowed 60days for public comment. One public
comment was received. The purpose of
this notice is to allow an additional 30
days for public comment. The National
Institute on Drug Abuse (NIDA),
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
(PATH) Study—Third Wave of Data
Collection—0925–0664—Revision,
National Institute on Drug Abuse
(NIDA), National Institutes of Health
(NIH), in partnership with the Food and
Drug Administration (FDA).
Need and Use of Information
Collection: This is a revision request
(OMB 0925–0664, expires 9/30/2016)
for the Population Assessment of
Tobacco and Health (PATH) Study to
conduct the third wave of data
collection. The PATH Study is a
national longitudinal cohort study of
tobacco use behavior and health among
the U.S. household population of adults
age 18 and older and youth ages 12 to
17. The Study conducts annual
interviews and collects biospecimens
from adults to assess within-person
changes and between-person differences
in tobacco-product use behaviors and
related health conditions over time. Its
longitudinal, population-based data will
help to enhance the evidence base that
informs FDA’s regulatory actions under
the Family Smoking Prevention and
Control Act to protect the Nation’s
public health and reduce its burden of
tobacco-related morbidity and mortality.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
54,434.
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_Submission@
omb.eop.gov or by fax to (202) 395–
6974, Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project,
contact: Dr. Kevin P. Conway, Deputy
Director, Division of Epidemiology,
Services, and Prevention Research,
NIDA, NIH, 6001 Executive Boulevard,
Room 5185, Rockville, MD 20852; or
call non-toll-free number (301) 443–
8755 or Email your request, including
your address to: PATHprojectofficer@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Population
Assessment of Tobacco and Health
ESTIMATED ANNUALIZED BURDEN HOURS
Form or activity name
Type of
respondent
Adult Extended Interview .......................................................
Consent for Adult Extended Interview ...................................
Adults ..........
Adults ..........
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Number of
respondents
Sfmt 4703
Number of
responses per
respondent
25,444
2,046
E:\FR\FM\17JNN1.SGM
1
1
17JNN1
Average
burden per
response
(in hours)
1
4/60
Total annual
burden hours
25,444
136
]]>Agencies
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34683-34684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14850]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-0990-new-30D]
Agency Information Collection Activities; Proposed Collection;
Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the Secretary (OS), Department of
Health and Human Services, announces plans to submit a new Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Comments submitted during the first public review of
this ICR will be provided to OMB. OMB will accept further comments from
the public on this ICR during the review and approval period.
DATES: Comments on the ICR must be received on or before July 17, 2015.
ADDRESSES: Submit your comments to
Information.CollectionClearance@hhs.gov or by calling (202) 690-6162.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the document identifier HHS-OS-0990-new-30D
for reference. Information Collection Request Title: Title X
Sustainability Assessment Tool for Grantees and Service Sites.
Abstract: The Office of Population Affairs within the Office of the
Assistant Secretary for Health seeks to collect data from the Title X
centers on efforts related to (1) assisting individuals in obtaining
health insurance; (2) partnerships with primary care providers; (3)
availability and use of electronic health records; (4) monitoring
patient care quality; (5) factors affecting revenue sources; and (6)
the way that sites conduct analyses to consider the cost of providing
services.
Need and Proposed Use of the Information: The Title X Family
Planning Program (``Title X program'' or ``program'') is the only
Federal grant program dedicated solely to providing individuals with
comprehensive family planning and related preventive health services
(e.g., screening for breast and cervical cancer, sexually transmitted
diseases (STDs), and human immunodeficiency virus [HIV]). By law,
priority is given to persons from low-income families (Section 1006[c]
of Title X of the Public Health Service Act, 42 U.S.C. 300). The Office
of Population Affairs (OPA) within the Office of the Assistant
Secretary for Health administers the Title X program.
The American health care system is experiencing unprecedented
levels of change as a result of the Patient Protection and Affordable
Care Act (ACA). The exact impact of these health system changes to
Title X centers needs to be assessed in order to ensure the
[[Page 34684]]
long term sustainability of the Title X network.
Data collected from this effort will be used to inform the work of
the training centers so they can better support the Title X grantees.
This data will help OPA better understand challenges affecting Title X
centers in order to better work with HHS entities and national
stakeholders to provide resources to Title X centers. Data will be
collected through an online data collection tool directly from grantees
and from Title X centers.
Likely Respondents: This annual reporting requirement is service
sites that receive funding (either directly from OPA or through a sub
recipient or grantee agency) for family planning services authorized
and funded by the Title X Family Planning Program [``Population
Research and Voluntary Family Planning Programs'' (91)], which was
enacted in 1970 as Title X of the Public Health Service Act (Section
1001 of Title X of the Public Health Service Act, 42 United States Code
[U.S.C.] 300).
Total Estimated Annualized Burden--Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of annualized
Type of respondent Form name Number of responses per burden per Annual total
respondents respondent response burden (hours)
(hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grantees....................................... Sustainability Assessment--Grantees.... 92 1 0.66 60.72
Service Sites.................................. Sustainability Assessment--Sites....... 4,168 1 0.66 2750.88
---------------------------------------------------------------
Total...................................... ....................................... 4,260 .............. .............. 2,811.60
--------------------------------------------------------------------------------------------------------------------------------------------------------
Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-14850 Filed 6-16-15; 8:45 am]
BILLING CODE 4150-48-P
