Agency Information Collection Activities: Submission for OMB Review; Comment Request, 13305-13307 [2014-05104]
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Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–05077 Filed 3–7–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10225, CMS–
10502, CMS–10503, CMS–10504 and
CMS–10506]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
ACTION:
Notice.
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
(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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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 on the collection(s) of
information must be received by the
OMB desk officer by April 9, 2014.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806, OR Email:
OIRA_submission@omb.eop.gov.
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SUMMARY:
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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 the 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: 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© 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 (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-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 that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Disclosures
Required of Certain Hospitals and
Critical Access Hospitals Regarding
Physician Ownership; Use: There is no
Medicare prohibition against physician
investment in a hospital or critical
access hospitals (CAH). Likewise, there
is no Medicare requirement that a
hospital or CAH have a physician onsite at all times; although, there is a
requirement that they be able to provide
basic elements of emergency care to
their patients. Medicare quality and
safety standards are designed to provide
a national framework that is sufficiently
flexible to apply simultaneously to
hospitals of varying sizes, offering
varying ranges of services in differing
settings across the nation. At the same
time, however, patients might consider
an ownership interest by their referring
physician, the presence of a physician
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13305
on-site or both to be important factors in
their decisions about where to seek
hospital care. A well-educated
consumer is essential to improving the
quality and efficiency of the healthcare
system. Accordingly, patients should be
made aware of the physician ownership
of a hospital, whether or not a physician
is present in the hospital at all times,
and the hospital’s plans to address
patients’ emergency medical conditions
when a physician is not present. The
intent of the disclosures is to increase
the transparency of the hospital’s
ownership and operations to patients as
they make decisions about receiving
care at the hospital. Please note that the
associated information collection
request has been revised subsequent to
the publication of the 60-day Federal
Register notice (78 FR 75925, December
13, 2013.). Form Number: CMS–10225
(OCN: 0938–1034); Frequency:
Occasionally; Affected Public: Private
sector—Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 2,597; Total Annual
Responses: 30,654,968; Total Annual
Hours: 261,447. (For policy questions
regarding this collection contact Teresa
Walden at 410–786–3755).
2. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Long Term Care
Hospital Quality Reporting Program:
Program Evaluation; Use: Section
3004(a) of the Affordable Care Act
(ACA) mandated that we establish a
quality reporting program for Long Term
Care Hospitals (LTCHs). Specifically,
section 3004(a) added section
1886(m)(5) to the Social Security Act
(the Act) to establish a quality reporting
program for LTCHs. This program
requires that quality data be submitted
by LTCH providers in a time, form and
manner specified by the Secretary.
We are interested in exploring how
LTCH providers are responding to the
new quality reporting program (QRP)
and its measures. We believe that it is
important to understand early trends in
outcomes, to make adjustments as
needed to enhance the effectiveness of
the program, and to seek opportunities
to minimize provider burden, and
ensure the QRP is useful and
meaningful to providers. The
methodology employed in the
evaluation is the utilization of
qualitative interviews (as opposed to
quantitative statistical methods). In
consultation with research experts, we
have decided that at this juncture it
would be meaningful to use a rich,
contextual approach to evaluation the
process and success of the QRP
initiative.
E:\FR\FM\10MRN1.SGM
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13306
Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
The decision to pursue this
quantitative methodology in 2013, in
which we learned that providers are
anxious to have their voice heard, but
that they did not feel comfortable
expressing themselves fully in public
open door forums. Providers desired
some level of confidentiality, which this
methodology affords. The intended use
of the information collected is to help
inform us about CMS providers’
experiences related to the QRPs, such as
program impact related to quality
improvement, burden, process-related
issues, and education. This will also
inform future measurement
development for the LTCH QRP, future
steps related to data validation, as well
as future monitoring and evaluation.
General findings may be used to discuss
our future efforts in the QRP. Form
Number: CMS–10502 (OCN: 0938–
NEW); Frequency: Occasionally;
Affected Public: Private sector—
Business or other for-profits and Notfor-profit organizations; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours: 71.
(For policy questions regarding this
collection contact Caroline Gallaher at
410–786–8705.)
3. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Inpatient
Rehabilitation Facilities Quality
Reporting Program: Program Evaluation;
Use: Section 3004 of the Affordable Care
Act (ACA) mandated that we establish
a quality reporting program for Inpatient
Rehabilitation Facilities (IRFs).
Specifically, section 3004(a) added
section 1886(j)(7) to the Social Security
Act (‘‘the Act’’) to establish a quality
reporting program (QRP) for IRFs. This
program requires IRFs to submit quality
data in a time, form and manner
specified by the Secretary.
We are interested in exploring how
IRF providers are responding to the new
QRP and its measures. We believe that
it is important to understand early
trends in outcomes, to make
adjustments as needed to enhance the
effectiveness of the program, and to seek
opportunities to minimize provider
burden, and ensure the quality reporting
program is useful and meaningful to the
providers. The methodology employed
in the evaluation is the utilization of
qualitative interviews (as opposed to
quantitative statistical methods). In
consultation with research experts, we
have decided that at this juncture it
would be meaningful to use a rich,
contextual approach to evaluation the
process and success of the QRP
initiative. The decision to pursue this
quantitative methodology in 2013, in
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18:00 Mar 07, 2014
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which we learned that providers are
anxious to have their voice heard, but
that they did not feel comfortable
expressing themselves fully in public
open door forums. Providers desired
some level of confidentiality, which this
methodology affords.
The intended use of the information
collected is to help inform CMS
providers’ experiences related to the
QRPs, such as program impact related to
quality improvement, burden, processrelated issues, and education. This will
also inform future measurement
development for the IRF QRP, future
steps related to data validation, as well
as future monitoring and evaluation.
General findings may be used to discuss
our future efforts in the QRP. Form
Number: CMS–10503 (OCN: 0938–
NEW); Frequency: Occasionally;
Affected Public: Private sector—
Business or other for-profits and Notfor-profit organizations; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours: 71.
(For policy questions regarding this
collection contact Caroline Gallaher at
410–786–8705.)
4. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Hospice Quality
Reporting Program: Program Evaluation;
Use: Section 3004(c) of the Affordable
Care Act (ACA) mandated that we
establish a quality reporting program
(QRP) for hospices. Specifically, section
3004(c) added section 1814(i)(5) to the
Social Security Act (the Act) to establish
a quality reporting program for
hospices. This program requires that
quality data be submitted by hospices
providers in a time, form and manner
specified by the Secretary.
We are interested in exploring how
hospice providers are responding to the
new QRP and its measures. We believe
that it is important to understand early
trends in outcomes, to make
adjustments as needed to enhance the
effectiveness of the program, and to seek
opportunities to minimize provider
burden, and ensure the quality reporting
program is useful and meaningful to the
providers. The methodology employed
in the evaluation is the utilization of
qualitative interviews (as opposed to
quantitative statistical methods). In
consultation with research experts, we
have decided that at this juncture it
would be meaningful to use a rich,
contextual approach to evaluation the
process and success of the QRP
initiative. The decision to pursue this
quantitative methodology in 2013, in
which we learned that providers are
anxious to have their voice heard, but
that they did not feel comfortable
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Fmt 4703
Sfmt 4703
expressing themselves fully in public
open door forums. Providers desired
some level of confidentiality, which this
methodology affords.
The intended use of the information
collected is to help inform CMS
providers’ experiences related to the
QRPs, such as program impact related to
quality improvement, burden, processrelated issues, and education. This will
also inform future measurement
development for the hospice QRP,
future steps related to data validation, as
well as future monitoring and
evaluation. General findings may be
used to discuss our future efforts in the
QRP. Form Number: CMS–10504 (OCN:
0938–NEW); Frequency: Occasionally;
Affected Public: Private sector—
Business or other for-profits and Notfor-profit organizations; Number of
Respondents: 30; Total Annual
Responses: 30; Total Annual Hours: 71.
(For policy questions regarding this
collection contact Caroline Gallaher at
410–786–8705.)
5. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Conditions of
Participation for Community Mental
Health Centers and Supporting
Regulations in 42 CFR 485; Use: On
June 17, 2011, we proposed for the first
time new conditions of participation
(CoPs) for community mental health
centers (CMHCs). We finalized nd were
finalized in the final rule that published
October 29, 2013 (78 FR 64604), with an
effective date 12-months after
publication of the final rule. These CoPs
which are based on criteria prescribed
in law and are standards designed to
ensure that each facility has properly
trained staff to provide the appropriate
safe physical environment for patients.
These particular standards reflect
comparable standards developed by
industry organizations such as the Joint
Commission. The primary users of this
information will be State agency
surveyors, CMS and CMHCs for the
purpose of ensuring compliance with
Medicare CoPs as well as ensuring the
quality of care provided by CMHCs to
patients. Form Number: CMS–10506
(OCN: 0938–NEW); Frequency:
Occasionally; Affected Public: Private
sector—Business or other for-profits and
Not-for-profit organizations; Number of
Respondents: 130; Total Annual
Responses: 79,530; Total Annual Hours:
2,060,342. (For policy questions
regarding this collection contact Mary
Rossi-Coajou at 410–786–6051.)
E:\FR\FM\10MRN1.SGM
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Federal Register / Vol. 79, No. 46 / Monday, March 10, 2014 / Notices
Dated: March 5, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–05104 Filed 3–7–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0768]
Determination That ZEFAZONE
(Cefmetazole Sodium) Injection,
Equivalent to 1 Gram Base/Vial and
Equivalent to 2 Gram Base/Vial, and
ZEFAZONE (Cefmetazole Sodium)
Intravenous Solution, Equivalent to 20
Milligrams Base/Milliliter and
Equivalent to 40 Milligrams Base/
Milliliter, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that ZEFAZONE (cefmetazole sodium)
Injection, equivalent to (EQ) 1 gram (g)
base/vial and EQ 2 g base/vial, and
ZEFAZONE (cefmetazole sodium)
Intravenous (IV) Solution, EQ 20
milligrams (mg) base/milliliter (mL) and
EQ 40 mg base/mL, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
ZEFAZONE (cefmetazole sodium)
Injection, EQ 1 g base/vial and EQ 2 g
base/vial, and ZEFAZONE (cefmetazole
sodium) IV Solution, EQ 20 mg base/mL
and 40 mg base/mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Kathy Schreier, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6246,
Silver Spring, MD 20993–0002, 301–
796–3432.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
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SUMMARY:
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dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the Orange
Book. Under FDA regulations, drugs are
removed from the list if the Agency
withdraws or suspends approval of the
drug’s NDA or ANDA for reasons of
safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
ZEFAZONE (cefmetazole sodium)
Injection, EQ 1 g base/vial and EQ 2 g
base/vial, is the subject of NDA 50–637,
held by Pharmacia & Upjohn, Inc.,
which was initially approved on
December 11, 1989; and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ
20 mg base/mL and EQ 40 mg base/mL,
is the subject of NDA 50–683, held by
Pharmacia & Upjohn, Inc., which was
initially approved on December 29,
1992. ZEFAZONE is a semisynthetic
cephem antibiotic that is indicated for
treatment of urinary tract infections,
lower respiratory tract infections, skin
and skin structure infections, and intraabdominal infections.
In a letter dated August 1, 2000,
Pharmacia & Upjohn, Inc., notified FDA
that ZEFAZONE (cefmetazole sodium)
Injection, EQ 1 g base/vial and EQ 2 g
base/vial, and ZEFAZONE (cefmetazole
sodium) IV Solution, EQ 20 mg base/mL
and EQ 40 mg base/mL, were no longer
being marketed and requested
withdrawal of NDA 50–637 and NDA
50–683. FDA moved the drug products
to the ‘‘Discontinued Drug Product List’’
section of the Orange Book and, in the
Federal Register of August 16, 2001 (66
FR 43017), announced that it was
withdrawing approval of NDA 50–637
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13307
and NDA 50–683 effective September
17, 2001.
Salus Pharma LLC submitted a citizen
petition dated June 17, 2013 (Docket No.
FDA–2013–P–0768), under 21 CFR
10.30, requesting that the Agency
determine whether ZEFAZONE
(cefmetazole sodium) Injection, EQ 1 g
base/vial and EQ 2 g base/vial, was
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not request that we
determine whether ZEFAZONE
(cefmetazole sodium) IV Solution, EQ
20 mg base/mL and EQ 40 mg base/mL,
approved under NDA 50–683, was
withdrawn for safety or effectiveness,
that product also has been discontinued.
On our own initiative, we have also
determined whether ZEFAZONE
(cefmetazole sodium) IV Solution, EQ
20 mg base/mL and EQ 40 mg base/mL,
was withdrawn for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that ZEFAZONE (cefmetazole
sodium) Injection, EQ 1 g base/vial and
EQ 2 g base/vial, and ZEFAZONE
(cefmetazole sodium) IV Solution, EQ
20 mg base/mL and EQ 40 mg base/mL,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that ZEFAZONE
(cefmetazole sodium) Injection, EQ 1 g
base/vial and EQ 2 g base/vial, and
ZEFAZONE (cefmetazole sodium) IV
Solution, EQ 20 mg base/mL and EQ 40
mg base/mL, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
ZEFAZONE (cefmetazole sodium)
Injection, EQ 1 g base/vial and EQ 2 g
base/vial, and ZEFAZONE (cefmetazole
sodium) IV Solution, EQ 20 mg base/mL
and EQ 40 mg base/mL, from sale. We
have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that these products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ZEFAZONE
(cefmetazole sodium) Injection, EQ 1 g
base/vial and EQ 2 g base/vial, and
ZEFAZONE (cefmetazole sodium) IV
Solution, EQ 20 mg base/mL and EQ 40
mg base/mL, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
E:\FR\FM\10MRN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13305-13307]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05104]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10225, CMS-10502, CMS-10503, CMS-10504 and
CMS-10506]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
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 (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 a second opportunity
for public comment on the notice. Interested persons are invited to
send comments regarding the burden estimate 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 on the collection(s) of information must be received by
the OMB desk officer by April 9, 2014.
ADDRESSES: When commenting on the proposed information collections,
please reference the document identifier or OMB control number. To be
assured consideration, comments and recommendations must be received by
the OMB desk officer via one of the following transmissions: OMB,
Office of Information and Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395-5806, OR Email: OIRA_submission@omb.eop.gov.
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 the 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: 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(copyright) 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 (44
U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of
information for public comment:
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Disclosures
Required of Certain Hospitals and Critical Access Hospitals Regarding
Physician Ownership; Use: There is no Medicare prohibition against
physician investment in a hospital or critical access hospitals (CAH).
Likewise, there is no Medicare requirement that a hospital or CAH have
a physician on-site at all times; although, there is a requirement that
they be able to provide basic elements of emergency care to their
patients. Medicare quality and safety standards are designed to provide
a national framework that is sufficiently flexible to apply
simultaneously to hospitals of varying sizes, offering varying ranges
of services in differing settings across the nation. At the same time,
however, patients might consider an ownership interest by their
referring physician, the presence of a physician on-site or both to be
important factors in their decisions about where to seek hospital care.
A well-educated consumer is essential to improving the quality and
efficiency of the healthcare system. Accordingly, patients should be
made aware of the physician ownership of a hospital, whether or not a
physician is present in the hospital at all times, and the hospital's
plans to address patients' emergency medical conditions when a
physician is not present. The intent of the disclosures is to increase
the transparency of the hospital's ownership and operations to patients
as they make decisions about receiving care at the hospital. Please
note that the associated information collection request has been
revised subsequent to the publication of the 60-day Federal Register
notice (78 FR 75925, December 13, 2013.). Form Number: CMS-10225 (OCN:
0938-1034); Frequency: Occasionally; Affected Public: Private sector--
Business or other for-profits and Not-for-profit institutions; Number
of Respondents: 2,597; Total Annual Responses: 30,654,968; Total Annual
Hours: 261,447. (For policy questions regarding this collection contact
Teresa Walden at 410-786-3755).
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: Long
Term Care Hospital Quality Reporting Program: Program Evaluation; Use:
Section 3004(a) of the Affordable Care Act (ACA) mandated that we
establish a quality reporting program for Long Term Care Hospitals
(LTCHs). Specifically, section 3004(a) added section 1886(m)(5) to the
Social Security Act (the Act) to establish a quality reporting program
for LTCHs. This program requires that quality data be submitted by LTCH
providers in a time, form and manner specified by the Secretary.
We are interested in exploring how LTCH providers are responding to
the new quality reporting program (QRP) and its measures. We believe
that it is important to understand early trends in outcomes, to make
adjustments as needed to enhance the effectiveness of the program, and
to seek opportunities to minimize provider burden, and ensure the QRP
is useful and meaningful to providers. The methodology employed in the
evaluation is the utilization of qualitative interviews (as opposed to
quantitative statistical methods). In consultation with research
experts, we have decided that at this juncture it would be meaningful
to use a rich, contextual approach to evaluation the process and
success of the QRP initiative.
[[Page 13306]]
The decision to pursue this quantitative methodology in 2013, in
which we learned that providers are anxious to have their voice heard,
but that they did not feel comfortable expressing themselves fully in
public open door forums. Providers desired some level of
confidentiality, which this methodology affords. The intended use of
the information collected is to help inform us about CMS providers'
experiences related to the QRPs, such as program impact related to
quality improvement, burden, process-related issues, and education.
This will also inform future measurement development for the LTCH QRP,
future steps related to data validation, as well as future monitoring
and evaluation. General findings may be used to discuss our future
efforts in the QRP. Form Number: CMS-10502 (OCN: 0938-NEW); Frequency:
Occasionally; Affected Public: Private sector--Business or other for-
profits and Not-for-profit organizations; Number of Respondents: 30;
Total Annual Responses: 30; Total Annual Hours: 71. (For policy
questions regarding this collection contact Caroline Gallaher at 410-
786-8705.)
3. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Inpatient Rehabilitation Facilities Quality Reporting Program: Program
Evaluation; Use: Section 3004 of the Affordable Care Act (ACA) mandated
that we establish a quality reporting program for Inpatient
Rehabilitation Facilities (IRFs). Specifically, section 3004(a) added
section 1886(j)(7) to the Social Security Act (``the Act'') to
establish a quality reporting program (QRP) for IRFs. This program
requires IRFs to submit quality data in a time, form and manner
specified by the Secretary.
We are interested in exploring how IRF providers are responding to
the new QRP and its measures. We believe that it is important to
understand early trends in outcomes, to make adjustments as needed to
enhance the effectiveness of the program, and to seek opportunities to
minimize provider burden, and ensure the quality reporting program is
useful and meaningful to the providers. The methodology employed in the
evaluation is the utilization of qualitative interviews (as opposed to
quantitative statistical methods). In consultation with research
experts, we have decided that at this juncture it would be meaningful
to use a rich, contextual approach to evaluation the process and
success of the QRP initiative. The decision to pursue this quantitative
methodology in 2013, in which we learned that providers are anxious to
have their voice heard, but that they did not feel comfortable
expressing themselves fully in public open door forums. Providers
desired some level of confidentiality, which this methodology affords.
The intended use of the information collected is to help inform CMS
providers' experiences related to the QRPs, such as program impact
related to quality improvement, burden, process-related issues, and
education. This will also inform future measurement development for the
IRF QRP, future steps related to data validation, as well as future
monitoring and evaluation. General findings may be used to discuss our
future efforts in the QRP. Form Number: CMS-10503 (OCN: 0938-NEW);
Frequency: Occasionally; Affected Public: Private sector--Business or
other for-profits and Not-for-profit organizations; Number of
Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 71.
(For policy questions regarding this collection contact Caroline
Gallaher at 410-786-8705.)
4. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection: Hospice
Quality Reporting Program: Program Evaluation; Use: Section 3004(c) of
the Affordable Care Act (ACA) mandated that we establish a quality
reporting program (QRP) for hospices. Specifically, section 3004(c)
added section 1814(i)(5) to the Social Security Act (the Act) to
establish a quality reporting program for hospices. This program
requires that quality data be submitted by hospices providers in a
time, form and manner specified by the Secretary.
We are interested in exploring how hospice providers are responding
to the new QRP and its measures. We believe that it is important to
understand early trends in outcomes, to make adjustments as needed to
enhance the effectiveness of the program, and to seek opportunities to
minimize provider burden, and ensure the quality reporting program is
useful and meaningful to the providers. The methodology employed in the
evaluation is the utilization of qualitative interviews (as opposed to
quantitative statistical methods). In consultation with research
experts, we have decided that at this juncture it would be meaningful
to use a rich, contextual approach to evaluation the process and
success of the QRP initiative. The decision to pursue this quantitative
methodology in 2013, in which we learned that providers are anxious to
have their voice heard, but that they did not feel comfortable
expressing themselves fully in public open door forums. Providers
desired some level of confidentiality, which this methodology affords.
The intended use of the information collected is to help inform CMS
providers' experiences related to the QRPs, such as program impact
related to quality improvement, burden, process-related issues, and
education. This will also inform future measurement development for the
hospice QRP, future steps related to data validation, as well as future
monitoring and evaluation. General findings may be used to discuss our
future efforts in the QRP. Form Number: CMS-10504 (OCN: 0938-NEW);
Frequency: Occasionally; Affected Public: Private sector--Business or
other for-profits and Not-for-profit organizations; Number of
Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 71.
(For policy questions regarding this collection contact Caroline
Gallaher at 410-786-8705.)
5. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Conditions of Participation for Community Mental Health Centers and
Supporting Regulations in 42 CFR 485; Use: On June 17, 2011, we
proposed for the first time new conditions of participation (CoPs) for
community mental health centers (CMHCs). We finalized nd were finalized
in the final rule that published October 29, 2013 (78 FR 64604), with
an effective date 12-months after publication of the final rule. These
CoPs which are based on criteria prescribed in law and are standards
designed to ensure that each facility has properly trained staff to
provide the appropriate safe physical environment for patients. These
particular standards reflect comparable standards developed by industry
organizations such as the Joint Commission. The primary users of this
information will be State agency surveyors, CMS and CMHCs for the
purpose of ensuring compliance with Medicare CoPs as well as ensuring
the quality of care provided by CMHCs to patients. Form Number: CMS-
10506 (OCN: 0938-NEW); Frequency: Occasionally; Affected Public:
Private sector--Business or other for-profits and Not-for-profit
organizations; Number of Respondents: 130; Total Annual Responses:
79,530; Total Annual Hours: 2,060,342. (For policy questions regarding
this collection contact Mary Rossi-Coajou at 410-786-6051.)
[[Page 13307]]
Dated: March 5, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-05104 Filed 3-7-14; 8:45 am]
BILLING CODE 4120-01-P
