Agency Information Collection Activities: Proposed Collection: Public Comment Request, 34764-34765 [2014-14193]
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34764
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
effectiveness of the device. This section
requires FDA to publish in the Federal
Register a notice of intent to exempt a
device, or of the petition, and to provide
a 30-day comment period. Within 120
days of publication of this document,
FDA must publish in the Federal
Register its final determination
regarding the exemption of the device
that was the subject of the notice. If FDA
fails to respond to a petition under this
section within 180 days of receiving it,
the petition shall be deemed granted.
II. Criteria for Exemption
There are a number of factors FDA
may consider to determine whether a
510(k) is necessary to provide
reasonable assurance of the safety and
effectiveness of a class II device. These
factors are discussed in the guidance the
Agency issued on February 19, 1998,
entitled ‘‘Procedures for Class II Device
Exemptions from Premarket
Notification, Guidance for Industry and
CDRH Staff.’’ That guidance is available
through the Internet at https://
www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf.
Send an email 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 159 to identify the guidance
you are requesting.
III. Proposed Class II Device
Exemptions
FDA has received the following
petition requesting an exemption from
premarket notification for a class II
device: Dave Smith, on behalf of
Adaptive Engineering, Inc., for its
wheelchair elevator device (commonly
known as a manually operated portable
wheelchair lift), classified under 21 CFR
890.3930.
emcdonald on DSK67QTVN1PROD with NOTICES
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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.
VerDate Mar<15>2010
16:35 Jun 17, 2014
Jkt 232001
Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–14215 Filed 6–17–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than August 18, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
AIDS Drug Assistance Program Data
Report OMB No. 0915–0345—Revision
Abstract: HRSA’s AIDS Drug
Assistance Program (ADAP) is funded
through The Ryan White HIV/AIDS
Program, Part B, Title XXVI of the
Public Health Service Act, which
provides grants to states and territories.
ADAP provides medications for the
treatment of HIV/AIDS. Program funds
may also be used to purchase health
SUMMARY:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
insurance for eligible clients and for
services that enhance access, adherence,
and monitoring of drug treatments.
Each of the 50 states, the District of
Columbia, Puerto Rico, and several
territories receive ADAP grants. As part
of the funding requirements, ADAPs
submit reports concerning information
on patients served, eligibility
requirements, pharmaceuticals
prescribed, pricing and other sources of
support to provide AIDS medication
treatment, cost data, and coordination
with Medicaid. Since 2005, ADAPs have
supplied aggregate data to HRSA using
the ADAP Quarterly Report (AQR).
However, aggregate data cannot be
analyzed with the detail that is required
to assess quality of care or to sufficiently
account for the use of Ryan White HIV/
AIDS Program Funds. To address this
limitation, HRSA’s HIV/AIDS Bureau
(HAB) developed a client-level data
system for ADAPs called the ADAP Data
Report (ADR), and in 2013 ADAPs
began submitting the ADR. As of April
30, 2014, HAB retired the AQR and now
only requires the submission of the
ADR. The ADR will be submitted
annually and consists of a Grantee
Report and a client-level data file.
Need and Proposed Use of the
Information: The Ryan White HIV/AIDS
Program requires the submission of
annual reports by the Secretary of the
Department of Health and Human
Services (HHS) to the appropriate
committees of Congress. The collection
of grantee-level and client-level data
enables HRSA to more effectively
respond to requests from the Secretary
of HHS. In addition, client-level
information is needed by HRSA in order
to respond to the request for reviews of
program performance and information
for strategic planning. Client-level data
is also needed to support the
implementation and monitoring of the
National HIV/AIDS Strategy (NHAS).
On April 11, 2012, a memo from the
Secretary of HHS directed HRSA with
other HHS Operating Divisions (OpDivs)
to work together to: (1) Identify seven
common core HIV/AIDS indicators; (2)
develop implementation plans to deploy
these indicators; and (3) streamline data
collection and reduce reporting by at
least 20 to 25 percent. In November
2012, the HIV/AIDS Indicators
Implementation Group (HAIIG),
comprised of representatives from HHS
OpDivs, the Department of Housing and
Urban Development, the Veterans’
Health Administration, and community
partners successfully identified the
required common core HIV/AIDS
indicators.
Revisions to the ADR are required to
support implementation of the core
E:\FR\FM\18JNN1.SGM
18JNN1
34765
Federal Register / Vol. 79, No. 117 / Wednesday, June 18, 2014 / Notices
indicators, streamline data collection,
and reduce the reporting burden. Eleven
data elements will be deleted from the
ADR and several variables were
modified to reduce reporting burden.
Sex at Birth, defined to the biological
sex assigned to the client at birth, will
be added to align with variables
collected by other HHS OpDivs. Type of
ADAP-funded insurance assistance
received, will also be added to track
ADAP’s payment of full or partial
premium, co-pays, and deductibles.
In addition to the new data elements
noted above, other new variables will be
added to the ADR to address provisions
set forth in Section 4302 of the
Affordable Care Act (ACA). The ACA
includes several provisions aimed at
eliminating health disparities in
America. Section 4302 (Understanding
health disparities: Data collection and
analysis) of the ACA focuses on the
standardization, collection, analysis,
and reporting of health disparities data.
Section 4302 requires the Secretary of
DHHS to establish data collection
standards for race, ethnicity, and sex.
The race/ethnicity data elements
include reporting of Hispanic, Asian,
and Native Hawaiian/Pacific Islander
subgroups. The categories for HHS data
standards for race and ethnicity are
based on the disaggregation of the OMB
standard used in the American
Community Survey (ACS) and the 2000
and 2010 Decennial Census. The
subgroup categories can be rolled-up to
the OMB standard. These new data
elements will be used in data analysis
intended to identify and understand
health disparities.
Likely Respondents: State ADAPs of
Ryan White Part B grantees.
Burden Statement: Burden in this
context means the time expended by
Number of
respondents
Form name
Number of
responses per
respondent
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
Total Estimated Annualized burden
hours:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Grantee Report ....................................................................
Client-level Report ...............................................................
54
54
1
1
54
54
6
109
324
5,886
Total ..............................................................................
54
........................
54
........................
6,210
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Dated: June 12, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
[FR Doc. 2014–14193 Filed 6–17–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK67QTVN1PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice.
VerDate Mar<15>2010
16:35 Jun 17, 2014
Jkt 232001
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than August 18, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
information request collection title for
reference.
Information Collection Request Title:
Federal Tort Claims Act Free Clinic
Application OMB No. 0915–0293—
Revision
Abstract: Under 42 U.S.C. 233(o) and
HRSA Program Assistance Letter (PAL)
2014–04, ‘‘Calendar Year 2015 Federal
Tort Claims Act (FTCA) Deeming
Application for Free Clinics,’’ free
clinics are required to submit annual,
renewal, and supplemental applications
for the process of deeming qualified
health care professionals, board
members, officers, and contractors for
FTCA medical malpractice coverage for
negligent acts and omissions that arise
from the performance of medical,
surgical, dental, or related functions
within the scope of the covered
individual’s employment. HRSA
proposes modifying the application
forms to reflect changes to eligible
personnel made by section 10608 of the
Affordable Care Act, amending 42
U.S.C. 233(o)(1), which extended FTCA
medical malpractice liability protection
to free clinic board members, officers,
employees, and contractors.
Additionally, HRSA proposes upgrading
the application to provide for electronic
submissions. Specifically, the
modifications include: (1) Inclusion of
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Notices]
[Pages 34764-34765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14193]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
no later than August 18, 2014.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: AIDS Drug Assistance Program
Data Report OMB No. 0915-0345--Revision
Abstract: HRSA's AIDS Drug Assistance Program (ADAP) is funded
through The Ryan White HIV/AIDS Program, Part B, Title XXVI of the
Public Health Service Act, which provides grants to states and
territories. ADAP provides medications for the treatment of HIV/AIDS.
Program funds may also be used to purchase health insurance for
eligible clients and for services that enhance access, adherence, and
monitoring of drug treatments.
Each of the 50 states, the District of Columbia, Puerto Rico, and
several territories receive ADAP grants. As part of the funding
requirements, ADAPs submit reports concerning information on patients
served, eligibility requirements, pharmaceuticals prescribed, pricing
and other sources of support to provide AIDS medication treatment, cost
data, and coordination with Medicaid. Since 2005, ADAPs have supplied
aggregate data to HRSA using the ADAP Quarterly Report (AQR). However,
aggregate data cannot be analyzed with the detail that is required to
assess quality of care or to sufficiently account for the use of Ryan
White HIV/AIDS Program Funds. To address this limitation, HRSA's HIV/
AIDS Bureau (HAB) developed a client-level data system for ADAPs called
the ADAP Data Report (ADR), and in 2013 ADAPs began submitting the ADR.
As of April 30, 2014, HAB retired the AQR and now only requires the
submission of the ADR. The ADR will be submitted annually and consists
of a Grantee Report and a client-level data file.
Need and Proposed Use of the Information: The Ryan White HIV/AIDS
Program requires the submission of annual reports by the Secretary of
the Department of Health and Human Services (HHS) to the appropriate
committees of Congress. The collection of grantee-level and client-
level data enables HRSA to more effectively respond to requests from
the Secretary of HHS. In addition, client-level information is needed
by HRSA in order to respond to the request for reviews of program
performance and information for strategic planning. Client-level data
is also needed to support the implementation and monitoring of the
National HIV/AIDS Strategy (NHAS).
On April 11, 2012, a memo from the Secretary of HHS directed HRSA
with other HHS Operating Divisions (OpDivs) to work together to: (1)
Identify seven common core HIV/AIDS indicators; (2) develop
implementation plans to deploy these indicators; and (3) streamline
data collection and reduce reporting by at least 20 to 25 percent. In
November 2012, the HIV/AIDS Indicators Implementation Group (HAIIG),
comprised of representatives from HHS OpDivs, the Department of Housing
and Urban Development, the Veterans' Health Administration, and
community partners successfully identified the required common core
HIV/AIDS indicators.
Revisions to the ADR are required to support implementation of the
core
[[Page 34765]]
indicators, streamline data collection, and reduce the reporting
burden. Eleven data elements will be deleted from the ADR and several
variables were modified to reduce reporting burden. Sex at Birth,
defined to the biological sex assigned to the client at birth, will be
added to align with variables collected by other HHS OpDivs. Type of
ADAP-funded insurance assistance received, will also be added to track
ADAP's payment of full or partial premium, co-pays, and deductibles.
In addition to the new data elements noted above, other new
variables will be added to the ADR to address provisions set forth in
Section 4302 of the Affordable Care Act (ACA). The ACA includes several
provisions aimed at eliminating health disparities in America. Section
4302 (Understanding health disparities: Data collection and analysis)
of the ACA focuses on the standardization, collection, analysis, and
reporting of health disparities data. Section 4302 requires the
Secretary of DHHS to establish data collection standards for race,
ethnicity, and sex. The race/ethnicity data elements include reporting
of Hispanic, Asian, and Native Hawaiian/Pacific Islander subgroups. The
categories for HHS data standards for race and ethnicity are based on
the disaggregation of the OMB standard used in the American Community
Survey (ACS) and the 2000 and 2010 Decennial Census. The subgroup
categories can be rolled-up to the OMB standard. These new data
elements will be used in data analysis intended to identify and
understand health disparities.
Likely Respondents: State ADAPs of Ryan White Part B grantees.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized burden hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Grantee Report.................. 54 1 54 6 324
Client-level Report............. 54 1 54 109 5,886
-------------------------------------------------------------------------------
Total....................... 54 .............. 54 .............. 6,210
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Dated: June 12, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-14193 Filed 6-17-14; 8:45 am]
BILLING CODE 4165-15-P
