Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Medical Device Registration and Listing, 23569-23570 [2013-09182]
Download as PDF
<![CDATA[
23569
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
waiver application is estimated at
$66,200. The cost consists of specimen
collection for the clinical study
(estimated $23,500); laboratory supplies,
reference testing and study oversight
(estimated $26,700); shipping and office
supplies (estimated $6,000); and
educational materials, including quick
reference instructions (estimated
$10,000).
In the Federal Register of September
14, 2012 (77 FR 56846), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one PRArelated comment.
The comment asserts that the amount
of time per response and the cost
associated with a waiver application are
underestimated. FDA has revised its
estimates based on the comment
received on the 60-day Federal Register
notice. As shown below, FDA is
increasing the hours per response from
780 to 1,200 hours. FDA is also
increasing the estimated operating and
maintenance cost burden from $66,200
to $350,000.
The Center for Devices and
Radiological Health (including both the
Office of In Vitro Diagnostics and the
Division of Biostatistics) maintains
dialogue with industry representatives
(the Advanced Medical Technology
Association), regarding development of
additional options regarding study
design and data analysis approaches for
certain devices to demonstrate they are
suitable candidates for waiver.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Total operating and
maintenance costs
CLIA waiver application ...............
40
1
40
1,200
48,000
$350,000
1 There
are no capital costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
CLIA waiver records ............................................................
40
1
40
2,800
112,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
[FR Doc. 2013–09180 Filed 4–18–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2012–N–0324]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry, FDA Staff, and
Foreign Governments: Fiscal Year
2012 Medical Device User Fee Small
Business Qualification and
Certification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry, FDA Staff, and
Foreign Governments: Fiscal Year 2012
Medical Device User Fee Small Business
Qualification and Certification’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:11 Apr 18, 2013
Jkt 229001
On
January 31, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Guidance for Industry, FDA
Staff, and Foreign Governments: Fiscal
Year 2012 Medical Device User Fee
Small Business Qualification and
Certification’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0508. The
approval expires on March 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09181 Filed 4–18–13; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0114]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Electronic Submission of Medical
Device Registration and Listing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Electronic Submission of Medical
Device Registration and Listing’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On August
06, 2012, the Agency submitted a
proposed collection of information
entitled ‘‘Electronic Submission of
Medical Device Registration and
Listing’’ to OMB for review and
SUMMARY:
E:\FR\FM\19APN1.SGM
19APN1
23570
Federal Register / Vol. 78, No. 76 / Friday, April 19, 2013 / Notices
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0625. The
approval expires on March 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09182 Filed 4–18–13; 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;
Comment Request
ACTION:
Notice
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, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
SUMMARY:
HRSA especially 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.
Information Collection Request Title:
Evaluating the Impact of 1115 Medicaid
Waivers on Ryan White HIV/AIDS
Program and Its Clients and Providers
(OMB No. 0915–xxxx)—New
Abstract: Section 1115 of the Social
Security Act allows states to develop,
test, and implement new approaches to
providing Medicaid coverage outside of
federal program rules. Leading up to full
implementation of the Affordable Care
Act, states have begun to use Section
1115 Medicaid demonstration waivers
as a ‘‘bridge’’ to 2014. This project will
examine 1115 Medicaid waivers that
have expanded eligibility to specifically
include people living with HIV/AIDS
(PLWH) who are not otherwise eligible
for Medicaid services. Since 1990, the
Ryan White HIV/AIDS Program
(RWHAP) has provided funding for
primary care, medications, and support
services for PLWH, helping fill the
health care and service gap for those
who are uninsured or ineligible for
Medicaid. Given the important role of
the RWHAP and Medicaid in meeting
the health care needs of PLWH, there is
a need to better understand how
Medicaid expansion and the 1115
Medicaid waivers will affect the
RWHAP and how the waivers have
prepared states for implementation of
the Affordable Care Act.
As part of this project, case studies
will be conducted in eight states that
have implemented 1115 Medicaid
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Form name
Qualitative Interview Data Collection Tool—State Medicaid
Agencies ...........................................................................
Qualitative Interview Data Collection Tool—RWHAP Part
A Administrators/Planning Councils .................................
Qualitative Interview Data Collection Tool—RWHAP Part
B/ADAP Directors and Coordinators ................................
Qualitative Interview Data Collection Tool—RWHAP Part
C Grantees/Clinical Providers ..........................................
17:11 Apr 18, 2013
Jkt 229001
PO 00000
Frm 00034
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
40
40
2
80
1
80
2
160
80
1
80
2
160
80
1
80
2
160
280
Fmt 4703
1
80
Total ..............................................................................
VerDate Mar<15>2010
Number of
responses per
respondent
waivers to expand Medicaid eligibility
for PLWH. The case studies will include
site visits and discussions with the state
Medicaid programs and with RWHAP
grantees and service providers to
examine the waivers and their impact
on PLWH. In addition, the studies will
explore whether and how the 1115
Medicaid waivers have helped states
and RWHAP grantees and providers
prepare for implementation of the
Affordable Care Act, including
providing insights into Medicaid
expansion. Data will be collected
through qualitative interviews, guided
by discussion tools with questions
tailored for four specific groups of
individuals from: (1) State Medicaid
Agencies; (2) Ryan White HIV/AIDS
Program Part B grantees and service
providers; (3) Ryan White HIV/AIDS
Program Part A grantees and service
providers; and (4) Ryan White HIV/
AIDS Program Part C grantees and
clinical providers.
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.
The annual estimate of burden is as
follows:
........................
280
........................
560
Sfmt 4703
E:\FR\FM\19APN1.SGM
19APN1
]]>Agencies
[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23569-23570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09182]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0114]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Electronic Submission of Medical
Device Registration and Listing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Electronic Submission of Medical
Device Registration and Listing'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On August 06, 2012, the Agency submitted a
proposed collection of information entitled ``Electronic Submission of
Medical Device Registration and Listing'' to OMB for review and
[[Page 23570]]
clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. OMB has now
approved the information collection and has assigned OMB control number
0910-0625. The approval expires on March 31, 2016. A copy of the
supporting statement for this information collection is available on
the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09182 Filed 4-18-13; 8:45 am]
BILLING CODE 4160-01-P
