Agency Information Collection Activities: Proposed Collection; Comment Request, 43887-43888 [2013-17476]
Download as PDF
43887
Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Notices
Healthy Communities activities that
were part of the original information
collection request.
CDC will continue to collect
information about each awardee’s
tobacco control objectives, planning,
activities, resources, partnerships,
strategies, and progress toward meeting
objectives. Awardees will use the
information reported through the
electronic MIS to manage and
coordinate their activities and to
improve their efforts. CDC will use the
information reported through the MIS to
document and monitor each awardee’s
progress and to make adjustments, as
needed, in the type and level of
technical assistance provided to them.
The information collection allows CDC
to oversee the use of federal funds, and
identify and disseminate information
about successful strategies implemented
by awardees. CDC also uses the
information to respond to Congressional
and stakeholder inquiries about awardee
activities, program implementation, and
program impact.
Progress reporting through the MIS is
required for DP09–901 awardees. There
are no costs to respondents other than
their time.
Estimated Annualized Burden Hours
Type of respondents
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
State Tobacco Control Program ......................................................................
53
2
6
636
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013–17525 Filed 7–19–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10493 and CMS–
10495]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. 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 or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:15 Jul 19, 2013
Jkt 229001
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments must be received by
September 20, 2013.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). To be
assured consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ______, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
DATES:
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10493 Nationwide Consumer
Assessment of Healthcare Providers
and Systems (DCAHPS) Survey for
Adults in Medicaid
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3520),
federal agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collections
1. Type of Information Collection
Request: New collection (request for a
new OMB control number); Title of
Information Collection: Nationwide
Consumer Assessment of Healthcare
Providers and Systems (DCAHPS)
Survey for Adults in Medicaid; Use: The
goal of the survey is to attain national
and state-by-state estimates of adult
Medicaid beneficiaries’ access and
experiences and satisfaction with care
E:\FR\FM\22JYN1.SGM
22JYN1
tkelley on DSK3SPTVN1PROD with NOTICES
43888
Federal Register / Vol. 78, No. 140 / Monday, July 22, 2013 / Notices
across different financing and delivery
models (e.g., managed care and fee-forservice) and population groups (e.g.,
beneficiaries with physical, mental or
both physical and mental disabilities,
dually eligible beneficiaries, all other
beneficiaries). The survey will serve as
baseline information on the experiences
of low-income adults during the early
stages of implementation of the
Affordable Care Act provision that
permits states to expand eligibility to
adults with income below 138 percent
of the federal poverty level who were
not previously eligible. Along with
states, we can use the survey
information as one indicator of the
quality of care within and across states.
It also will be used to assist us along
with the states in efforts to provide
better care and more affordable care to
Medicaid beneficiaries. Form Number:
CMS–10493 (OCN: 0938–New);
Frequency: Once; Affected Public:
Individuals and households; Number of
Respondents: 1,500,000; Total Annual
Responses: 510,000. Total Annual
Hours: 170,000. (For policy questions
regarding this collection contact Marsha
Lillie-Blanton at 410–786–8856.).
2. Type of Information Collection
Request: New collection (request for a
new OMB control number); Title of
Information Collection: Registration,
Attestation, Dispute & Resolution,
Assumptions Document and Data
Retention Requirements for Open
Payments; Use: Section 6002 of the
Affordable Care Act added section
1128G to the Social Security Act (Act),
which requires applicable
manufacturers and applicable group
purchasing organizations (GPOs) of
covered drugs, devices, biologicals, or
medical supplies to report annually to
CMS certain payments or other transfers
of value to physicians and teaching
hospitals, as well as, certain information
regarding the ownership or investment
interests held by physicians or their
immediate family members in
applicable manufacturers or applicable
GPOs.
Specifically, applicable manufacturers
of covered drugs, devices, biologicals,
and medical supplies are required to
submit on an annual basis the
information required in section
1128G(a)(1) of the Act about certain
payments or other transfers of value
made to physicians and teaching
hospitals (collectively called covered
recipients) during the course of the
preceding calendar year. Similarly,
section 1128G(a)(2) of the Act requires
applicable manufacturers and
applicable GPOs to disclose any
ownership or investment interests in
such entities held by physicians or their
VerDate Mar<15>2010
17:15 Jul 19, 2013
Jkt 229001
immediate family members, as well as
information on any payments or other
transfers of value provided to such
physician owners or investors.
Applicable manufacturers must report
the required payment and other transfer
of value information annually to CMS in
an electronic format. The statute also
provides that applicable manufacturers
and applicable GPOs must report
annually to CMS the required
information about physician ownership
and investment interests, including
information on any payments or other
transfers of value provided to physician
owners or investors, in an electronic
format by the same date. Applicable
manufacturers and applicable GPOs are
subject to civil monetary penalties
(CMPs) for failing to comply with the
reporting requirements of the statute.
We are required by statute to publish
the reported data on a public Web site.
The data must be downloadable, easily
searchable, and aggregated. In addition,
we must submit annual reports to the
Congress and each state summarizing
the data reported. Finally, section
1128G of the Act generally preempts
state laws that require disclosure of the
same type of information by
manufacturers.
We published a final rule in 2013 to
implement this program, which
included several information collections
subject to the Paperwork Reduction Act.
This information collection request is to
inform the public about information
collected that is necessary for
registration, attestation, dispute
resolution and corrections, record
retention, and submitting an
assumptions document within Open
Payments. Form Number: CMS–10495
(OCN: 0938–New); Frequency: Once;
Affected Public: Private sector—
Business or other for-profits; Number of
Respondents: 451,582; Total Annual
Responses: 451,582. Total Annual
Hours: 949,005. (For policy questions
regarding this collection contact Melissa
Heesters at 410–786–0618.).
Dated: July 16, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–17476 Filed 7–19–13; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0838]
Compliance Policy Guide Sec.
253.100—Use of Units of Plasma and
Fresh Frozen Plasma Which Have
Been Thawed; Withdrawal of
Compliance Policy Guide
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
The Food and Drug
Administration (FDA) is announcing the
withdrawal of the compliance policy
guide (CPG) entitled ‘‘Sec. 253.100—Use
of Units of Plasma and Fresh Frozen
Plasma Which Have Been Thawed,’’
issued October 1, 1980, and revised in
March 1995.
DATES: The withdrawal is effective July
22, 2013.
FOR FURTHER INFORMATION CONTACT:
Robert L. Hummel, Medical Products
and Tobacco Policy Staff, Office of
Policy and Risk Management, Office of
Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 301–796–4510.
SUPPLEMENTARY INFORMATION: FDA
issued the CPG entitled ‘‘Sec. 253.100—
Use of Units of Plasma and Fresh Frozen
Plasma Which Have Been Thawed’’ on
October 1, 1980, and revised it in March
1995. FDA originally issued CPG Sec.
253.100 to provide FDA’s current
thinking regarding the time limits for
when thawed frozen plasma should be
used for transfusion. At the time of
issuance of the CPG, 21 CFR
606.122(m)(3) provided that the
instruction circular shall include, when
applicable, instructions to begin
administration of the product within 6
hours after thawing. The CPG noted a
planned regulatory change that would
allow greater flexibility in the time of
administration requirements for frozen
plasma products.
In a final rule published in the
Federal Register on January 3, 2012 (77
FR 7), with an effective date of July 2,
2012, FDA modified the time limits
contained in the instruction circular for
when administration of thawed frozen
plasma products begins, as required by
21 CFR 606.122(m)(3), to ‘‘within a
specified time after thawing.’’ As noted
in the preamble to the final rule, the
change was made ‘‘to provide industry
with increased flexibility for developing
and specifying timeframes for which
thawed plasma components can still be
used for transfusion if stored at
SUMMARY:
E:\FR\FM\22JYN1.SGM
22JYN1
Agencies
[Federal Register Volume 78, Number 140 (Monday, July 22, 2013)]
[Notices]
[Pages 43887-43888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17476]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10493 and CMS-10495]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. 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 or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including any of the following subjects: (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.
DATES: Comments must be received by September 20, 2013.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number ------------, Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at (410) 786-1326.
FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10493 Nationwide Consumer Assessment of Healthcare Providers and
Systems (DCAHPS) Survey for Adults in Medicaid
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. The term ``collection of information'' is defined
in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests
or requirements that members of the public submit reports, keep
records, or provide information to a third party. Section 3506(c)(2)(A)
of the PRA requires federal agencies to publish a 60-day notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension or reinstatement of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, CMS is publishing this
notice.
Information Collections
1. Type of Information Collection Request: New collection (request
for a new OMB control number); Title of Information Collection:
Nationwide Consumer Assessment of Healthcare Providers and Systems
(DCAHPS) Survey for Adults in Medicaid; Use: The goal of the survey is
to attain national and state-by-state estimates of adult Medicaid
beneficiaries' access and experiences and satisfaction with care
[[Page 43888]]
across different financing and delivery models (e.g., managed care and
fee-for-service) and population groups (e.g., beneficiaries with
physical, mental or both physical and mental disabilities, dually
eligible beneficiaries, all other beneficiaries). The survey will serve
as baseline information on the experiences of low-income adults during
the early stages of implementation of the Affordable Care Act provision
that permits states to expand eligibility to adults with income below
138 percent of the federal poverty level who were not previously
eligible. Along with states, we can use the survey information as one
indicator of the quality of care within and across states. It also will
be used to assist us along with the states in efforts to provide better
care and more affordable care to Medicaid beneficiaries. Form Number:
CMS-10493 (OCN: 0938-New); Frequency: Once; Affected Public:
Individuals and households; Number of Respondents: 1,500,000; Total
Annual Responses: 510,000. Total Annual Hours: 170,000. (For policy
questions regarding this collection contact Marsha Lillie-Blanton at
410-786-8856.).
2. Type of Information Collection Request: New collection (request
for a new OMB control number); Title of Information Collection:
Registration, Attestation, Dispute & Resolution, Assumptions Document
and Data Retention Requirements for Open Payments; Use: Section 6002 of
the Affordable Care Act added section 1128G to the Social Security Act
(Act), which requires applicable manufacturers and applicable group
purchasing organizations (GPOs) of covered drugs, devices, biologicals,
or medical supplies to report annually to CMS certain payments or other
transfers of value to physicians and teaching hospitals, as well as,
certain information regarding the ownership or investment interests
held by physicians or their immediate family members in applicable
manufacturers or applicable GPOs.
Specifically, applicable manufacturers of covered drugs, devices,
biologicals, and medical supplies are required to submit on an annual
basis the information required in section 1128G(a)(1) of the Act about
certain payments or other transfers of value made to physicians and
teaching hospitals (collectively called covered recipients) during the
course of the preceding calendar year. Similarly, section 1128G(a)(2)
of the Act requires applicable manufacturers and applicable GPOs to
disclose any ownership or investment interests in such entities held by
physicians or their immediate family members, as well as information on
any payments or other transfers of value provided to such physician
owners or investors. Applicable manufacturers must report the required
payment and other transfer of value information annually to CMS in an
electronic format. The statute also provides that applicable
manufacturers and applicable GPOs must report annually to CMS the
required information about physician ownership and investment
interests, including information on any payments or other transfers of
value provided to physician owners or investors, in an electronic
format by the same date. Applicable manufacturers and applicable GPOs
are subject to civil monetary penalties (CMPs) for failing to comply
with the reporting requirements of the statute. We are required by
statute to publish the reported data on a public Web site. The data
must be downloadable, easily searchable, and aggregated. In addition,
we must submit annual reports to the Congress and each state
summarizing the data reported. Finally, section 1128G of the Act
generally preempts state laws that require disclosure of the same type
of information by manufacturers.
We published a final rule in 2013 to implement this program, which
included several information collections subject to the Paperwork
Reduction Act. This information collection request is to inform the
public about information collected that is necessary for registration,
attestation, dispute resolution and corrections, record retention, and
submitting an assumptions document within Open Payments. Form Number:
CMS-10495 (OCN: 0938-New); Frequency: Once; Affected Public: Private
sector--Business or other for-profits; Number of Respondents: 451,582;
Total Annual Responses: 451,582. Total Annual Hours: 949,005. (For
policy questions regarding this collection contact Melissa Heesters at
410-786-0618.).
Dated: July 16, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2013-17476 Filed 7-19-13; 8:45 am]
BILLING CODE 4120-01-P