Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 41404-41405 [2013-16599]
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41404
Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices
to be retained for at least 10 years
beyond the date of transplantation if
known, distribution, disposition, or
expiration of the tissue, whichever is
the latest. Section 1270.35(a) through (d)
requires specific records to be
maintained to document the following:
(1) The results and interpretation of all
required infectious disease tests; (2)
information on the identity and relevant
medical records of the donor; (3) the
receipt and/or distribution of human
tissue, and (4) the destruction or other
disposition of human tissue.
Respondents to this collection of
information are manufacturers of human
tissue intended for transplantation.
Based on information from the Center
for Biologics Evaluation and Research’s
(CBER’s) database system, FDA
estimates that there are approximately
281 tissue establishments, of which 185
are conventional tissue banks and 96 are
eye tissue banks. Based on information
provided by industry, there are an
estimated total of 1,959,270
conventional tissue products and 82,741
eye tissue products recovered per year
with an average of 25 percent of the
tissue discarded due to unsuitability for
transplant. In addition, there are an
estimated 73,075 donors of conventional
tissue and 49,026 donors of eye tissue
each year.
Accredited members of the American
Association of Tissue Banks (AATB)
and Eye Bank Association of America
(EBAA) adhere to standards of those
organizations that are comparable to the
recordkeeping requirements in part
1270. Based on information provided by
CBER’s database system, 90 percent of
the conventional tissue banks are
members of AATB (185 × 90 percent =
166), and 85 percent of eye tissue banks
are members of EBAA (96 × 85 percent
= 82). Therefore, recordkeeping by these
248 establishments (166 + 82 = 248) is
excluded from the burden estimates as
usual and customary business activities
(5 CFR 1320.3(b)(2)). The recordkeeping
burden, thus, is estimated for the
remaining 33 establishments, which is
12 percent of all establishments (281 ¥
248 = 33, or 33/281 = 12 percent).
FDA assumes that all current tissue
establishments have developed written
procedures in compliance with part
1270. Therefore, their information
collection burden is for the general
review and update of written
procedures estimated to take an annual
average of 24 hours, and for the
recording and justifying of any
deviations from the written procedures
under § 1270.31(a) and (b), estimated to
take an annual average of 1 hour. The
information collection burden for
maintaining records concurrently with
the performance of each significant
screening and testing step and for
retaining records for 10 years under
§ 1270.33(a), (f), and (h) include
documenting the results and
interpretation of all required infectious
disease tests and results and the identity
and relevant medical records of the
donor required under § 1270.35(a) and
(b). Therefore, the burden under these
provisions is calculated together in table
1 of this document. The recordkeeping
estimates for the number of total annual
records and hours per record are based
on information provided by industry
and FDA experience.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR Section
1270.31(a), (b), (c), and (d) 2 .......
1270.31(a) and 1270.31(b) 3 ........
1270.33(a), (f), and (h), and
1270.35(a) and (b) ...................
1270.35(c) ....................................
1270.35(d) ....................................
Total annual
records
Average burden
per recordkeeping
Total hours
33
33
1
2
33
66
24
1
792
66
33
33
33
7,869.48
14,850.96
1,856.36
259,693
490,082
61,260
1
1
1
259,693
490,082
61,260
Total ......................................
811,893
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
and update of standard operating procedures (SOPs).
3 Documentation of deviations from SOPs.
2 Review
Dated: July 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16556 Filed 7–9–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TKELLEY on DSK3SPTVN1PROD with NOTICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
VerDate Mar<15>2010
17:42 Jul 09, 2013
Jkt 229001
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
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
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\10JYN1.SGM
10JYN1
41405
Federal Register / Vol. 78, No. 132 / Wednesday, July 10, 2013 / Notices
examine 1115 Medicaid waivers that
have expanded eligibility to include
specifically 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.
As part of this project, case studies
will be conducted in eight states that
have implemented 1115 Medicaid
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.
Need and Proposed Use of the
Information: Given the important role of
the RWHAP and Medicaid in meeting
the health care needs of PLWH, there is
a need to understand better, 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.
Likely Respondents: 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) RWHAP Part B
grantees and service providers; (3)
RWHAP Part A grantees and service
providers; and (4) and RWHAP White
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 ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Qualitative Interview Data Collection Tool for State Medicaid Agency Groups ........................................................
Qualitative Interview Data Collection Tool for Ryan White
Part A Administrators and Members of Planning Councils ....................................................................................
Qualitative Interview Data Collection Tool for Ryan White
Part A Administrators and Members of Planning Councils ....................................................................................
Qualitative Interview Data Collection Tool for Ryan White
Part B and ADAP (AIDS Directors, Part B Coordinators
and ADAP Coordinators) ..................................................
Qualitative Interview Data Collection Tool for Ryan White
Clinical Providers (RW Part C Grantees in clinical settings or Similar Clinical Care Providers) ..........................
[FR Doc. 2013–16599 Filed 7–9–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TKELLEY on DSK3SPTVN1PROD 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
17:42 Jul 09, 2013
Jkt 229001
Total burden
hours
40
2
80
64
1
64
2
128
16
1
16
2
32
80
1
80
2
160
80
1
80
2
160
280
........................
........................
........................
560
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
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Frm 00054
Average
burden per
response
(in hours)
1
SUMMARY:
PO 00000
Total
responses
40
Total ..............................................................................
Dated: July 3, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
Number of
responses per
respondent
Fmt 4703
Sfmt 4703
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
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.
FOR FURTHER INFORMATION CONTACT:
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10JYN1.SGM
10JYN1
]]>Agencies
[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Notices]
[Pages 41404-41405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16599]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received within 30 days of this
notice.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION: 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
[[Page 41405]]
examine 1115 Medicaid waivers that have expanded eligibility to include
specifically 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.
As part of this project, case studies will be conducted in eight
states that have implemented 1115 Medicaid 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.
Need and Proposed Use of the Information: Given the important role
of the RWHAP and Medicaid in meeting the health care needs of PLWH,
there is a need to understand better, 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.
Likely Respondents: 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)
RWHAP Part B grantees and service providers; (3) RWHAP Part A grantees
and service providers; and (4) and RWHAP White 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 ICR 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)
----------------------------------------------------------------------------------------------------------------
Qualitative Interview Data 40 1 40 2 80
Collection Tool for State
Medicaid Agency Groups.........
Qualitative Interview Data 64 1 64 2 128
Collection Tool for Ryan White
Part A Administrators and
Members of Planning Councils...
Qualitative Interview Data 16 1 16 2 32
Collection Tool for Ryan White
Part A Administrators and
Members of Planning Councils...
Qualitative Interview Data 80 1 80 2 160
Collection Tool for Ryan White
Part B and ADAP (AIDS
Directors, Part B Coordinators
and ADAP Coordinators).........
Qualitative Interview Data 80 1 80 2 160
Collection Tool for Ryan White
Clinical Providers (RW Part C
Grantees in clinical settings
or Similar Clinical Care
Providers).....................
-------------------------------------------------------------------------------
Total....................... 280 .............. .............. .............. 560
----------------------------------------------------------------------------------------------------------------
Dated: July 3, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-16599 Filed 7-9-13; 8:45 am]
BILLING CODE 4165-15-P
