Proposed Data Collections Submitted for Public Comment and Recommendations, 66363-66364 [2013-26469]
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Federal Register / Vol. 78, No. 214 / Tuesday, November 5, 2013 / 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. 2013–26436 Filed 11–4–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day-14–0210]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to CDC, LeRoy Richardson,
1600 Clifton Road, MS D–74, Atlanta,
GA 30333 or send an email to omb@
cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
List of Ingredients Added to Tobacco
in the Manufacture of Cigarette Products
(OMB No. 0920–0210, exp. 2/28/2014)—
Extension—Office on Smoking and
Health, National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Cigarette smoking is the leading
preventable cause of premature death
and disability in the United States. Each
year, more than 443,000 premature
deaths occur as the result of diseases
related to cigarette smoking. The
Centers for Disease Control and
Prevention (CDC), Office on Smoking
and Health (OSH) has the primary
responsibility for the Department of
Health and Human Services (HHS)
smoking and health program. HHS’s
overall goal is to reduce death and
disability resulting from cigarette
smoking and other forms of tobacco use
through programs of information,
education and research.
The Comprehensive Smoking
Education Act of 1984 (CSEA, 15 U.S.C.
1336 or Pub. L. 98–474) requires each
person who manufactures, packages, or
imports cigarettes to provide the
Secretary of HHS with a list of
ingredients added to tobacco in the
manufacture of cigarettes. The
legislation also authorizes HHS to
undertake research, and to report to the
Congress (as deemed appropriate)
discussing the health effects of these
ingredients.
HHS has delegated responsibility for
implementing the CSEA’s ingredient
reporting requirements to CDC’s OSH.
OSH has collected ingredient reports on
cigarette products since 1986.
66363
Respondents are commercial cigarette
manufacturers, packagers, or importers,
or their designated representatives.
Respondents are not required to submit
specific forms; however, they are
required to submit a list of all
ingredients used in their products. CDC
requires the ingredient report to be
submitted by chemical name and
Chemical Abstract Service (CAS)
Registration Number, consistent with
accepted reporting practices for other
companies currently required to report
ingredients added to other consumer
products. Typically, respondents submit
a summary report to CDC with the
ingredient information for multiple
products, or a statement that there are
no changes to their previously
submitted ingredient report. The
estimated burden per response is 6.5
hours. The total estimated annualized
burden hours are 501.
Ingredient reports for new products
are due at the time of first importation.
Thereafter, ingredient reports are due
annually on March 31. Information is
submitted to OSH by mailing a written
report on the respondent’s letterhead,
which may be accompanied by a
compact disk (CD), three-inch floppy
disk, or thumb drive. Annual ingredient
reports should be mailed to: Office on
Smoking and Health, Attention: FCLAA
Program Manager, National Center for
Chronic Disease Prevention and Health
Promotion, Centers for Disease Control
and Prevention, 4770 Buford Highway,
NE., MS F–79 Atlanta, GA 30341–3717.
Electronic mail submissions are not
accepted. Upon receipt and verification
of the annual ingredient report, OSH
issues a Certificate of Compliance to the
respondent.
There are no costs to respondents
other than their time. Office of
Management and Budget (OMB)
approval is requested for three years.
Estimated Annualized Burden Hours
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Cigarette Manufacturers, Packagers, and Importers .......................................
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Type of respondents
77
1
6.5
501
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66364
Federal Register / Vol. 78, No. 214 / Tuesday, November 5, 2013 / Notices
Leroy A. 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. 2013–26469 Filed 11–4–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3110–FN]
Medicare & Medicaid Programs:
Application From the Accreditation
Commission for Health Care for
Continued CMS-Approval of Its
Hospice Accreditation Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve the
Accreditation Commission for Health
Care (ACHC) for continued recognition
as a national accrediting organization
for hospices that wish to participate in
the Medicare or Medicaid programs.
DATES: Effective: This final notice is
effective November 27, 2013 through
November 27, 2019.
FOR FURTHER INFORMATION CONTACT:
Valarie Lazerowich, (410) 786–4750.
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
SUPPLEMENTARY INFORMATION:
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
I. Background
Under the Medicare program, eligible
beneficiaries may receive covered
services in a hospice provided certain
requirements are met. Section 1861(dd)
of the Social Security Act (the Act)
establishes distinct criteria for facilities
seeking designation as a hospice.
Regulations concerning provider
agreements are at 42 CFR part 489 and
those pertaining to activities relating to
the survey and certification of facilities
are at 42 CFR part 488. The regulations
at 42 CFR part 418 specify the
conditions that a hospice must meet to
participate in the Medicare program, the
scope of covered services, and the
conditions for Medicare payment for
hospices.
Generally, to enter into an agreement,
a hospice must first be certified by a
state survey agency as complying with
the conditions or requirements set forth
in part 418. Thereafter, the hospice is
subject to regular surveys by a state
survey agency to determine whether it
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continues to meet these requirements.
However, there is an alternative to
surveys by state agencies. Certification
by a nationally recognized accreditation
program can substitute for ongoing state
review.
Section 1865(a)(1) of the Act provides
that, if a provider entity demonstrates
through accreditation by an approved
national accrediting organization that all
applicable Medicare conditions are met
or exceeded, CMS will deem those
provider entities as having met the
requirements. Accreditation by an
accrediting organization is voluntary
and is not required for Medicare
participation.
If an accrediting organization is
recognized by the Secretary of the
Department of Health and Human
Services as having standards for
accreditation that meet or exceed
Medicare requirements, any provider
entity accredited by the national
accrediting body’s approved program
would be deemed to have met the
Medicare conditions. A national
accrediting organization applying for
approval of its accreditation program
under part 488, subpart A, must provide
CMS with reasonable assurance that the
accrediting organization requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning the
approval of accrediting organizations
are set forth at § 488.4 and § 488.8(d)(3).
The regulations at § 488.8(d)(3) require
accrediting organizations to reapply for
continued approval of its accreditation
program every 6 years or sooner as
determined by CMS.
The ACHC’s current term of approval
for their hospice accreditation program
expires November 27, 2013.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act
provides a statutory timetable to ensure
that our review of applications for CMSapproval of an accreditation program is
conducted in a timely manner. The Act
provides us 210 days after the date of
receipt of a complete application, with
any documentation necessary to make
the determination, to complete our
survey activities and application
process. Within 60 days after receiving
a complete application, we must
publish a notice in the Federal Register
that identifies the national accrediting
body making the request, describes the
request, and provides no less than a 30day public comment period. At the end
of the 210-day period, we must publish
a notice in the Federal Register
approving or denying the application.
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III. Provisions of the Proposed Notice
On May 3, 2013, we published a
proposed notice in the Federal Register
(78 FR 26036) announcing Accreditation
Commission for Health Care’s request
for approval of its hospice accreditation
program. In the proposed notice, we
detailed our evaluation criteria. Under
section 1865(a)(2) of the Act and in our
regulations at § 488.4 and § 488.8, we
conducted a review of ACHC’s
application in accordance with the
criteria specified by our regulations,
which include, but are not limited to the
following:
• An onsite administrative review of
ACHC’s: (1) Corporate policies; (2)
financial and human resources available
to accomplish the proposed surveys; (3)
procedures for training, monitoring, and
evaluation of its surveyors; (4) ability to
investigate and respond appropriately to
complaints against accredited facilities;
and (5) survey review and decisionmaking process for accreditation.
• The comparison of ACHC’s
accreditation requirements to our
current Medicare hospice conditions of
participation.
• A documentation review of ACHC’s
survey process to determine the
following:
++ The composition of the survey
team, surveyor qualifications, and
ACHC’s ability to provide continuing
survey or training.
++ Comparability of ACHC’s
processes to those of state survey
agencies, including survey frequency,
and the ability to investigate and
respond appropriately to complaints
against accredited facilities.
++ ACHC’s procedures for
monitoring hospices out of compliance
with ACHC’s program requirements.
The monitoring procedures are used
only when ACHC identifies
noncompliance. If noncompliance is
identified through validation reviews,
the State survey agency monitors
corrections as specified at § 488.7(d).
++ ACHC’s ability to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ ACHC’s ability to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of staff and other
resources.
++ ACHC’s ability to provide
adequate funding for performing
required surveys.
++ ACHC’s policies with respect to
whether surveys are announced or
unannounced.
E:\FR\FM\05NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Notices]
[Pages 66363-66364]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26469]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-14-0210]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to CDC, LeRoy Richardson, 1600 Clifton Road, MS D-74,
Atlanta, GA 30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
List of Ingredients Added to Tobacco in the Manufacture of
Cigarette Products (OMB No. 0920-0210, exp. 2/28/2014)--Extension--
Office on Smoking and Health, National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Cigarette smoking is the leading preventable cause of premature
death and disability in the United States. Each year, more than 443,000
premature deaths occur as the result of diseases related to cigarette
smoking. The Centers for Disease Control and Prevention (CDC), Office
on Smoking and Health (OSH) has the primary responsibility for the
Department of Health and Human Services (HHS) smoking and health
program. HHS's overall goal is to reduce death and disability resulting
from cigarette smoking and other forms of tobacco use through programs
of information, education and research.
The Comprehensive Smoking Education Act of 1984 (CSEA, 15 U.S.C.
1336 or Pub. L. 98-474) requires each person who manufactures,
packages, or imports cigarettes to provide the Secretary of HHS with a
list of ingredients added to tobacco in the manufacture of cigarettes.
The legislation also authorizes HHS to undertake research, and to
report to the Congress (as deemed appropriate) discussing the health
effects of these ingredients.
HHS has delegated responsibility for implementing the CSEA's
ingredient reporting requirements to CDC's OSH. OSH has collected
ingredient reports on cigarette products since 1986. Respondents are
commercial cigarette manufacturers, packagers, or importers, or their
designated representatives. Respondents are not required to submit
specific forms; however, they are required to submit a list of all
ingredients used in their products. CDC requires the ingredient report
to be submitted by chemical name and Chemical Abstract Service (CAS)
Registration Number, consistent with accepted reporting practices for
other companies currently required to report ingredients added to other
consumer products. Typically, respondents submit a summary report to
CDC with the ingredient information for multiple products, or a
statement that there are no changes to their previously submitted
ingredient report. The estimated burden per response is 6.5 hours. The
total estimated annualized burden hours are 501.
Ingredient reports for new products are due at the time of first
importation. Thereafter, ingredient reports are due annually on March
31. Information is submitted to OSH by mailing a written report on the
respondent's letterhead, which may be accompanied by a compact disk
(CD), three-inch floppy disk, or thumb drive. Annual ingredient reports
should be mailed to: Office on Smoking and Health, Attention: FCLAA
Program Manager, National Center for Chronic Disease Prevention and
Health Promotion, Centers for Disease Control and Prevention, 4770
Buford Highway, NE., MS F-79 Atlanta, GA 30341-3717. Electronic mail
submissions are not accepted. Upon receipt and verification of the
annual ingredient report, OSH issues a Certificate of Compliance to the
respondent.
There are no costs to respondents other than their time. Office of
Management and Budget (OMB) approval is requested for three years.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Cigarette Manufacturers, Packagers, and 77 1 6.5 501
Importers..................................
----------------------------------------------------------------------------------------------------------------
[[Page 66364]]
Leroy A. 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. 2013-26469 Filed 11-4-13; 8:45 am]
BILLING CODE 4163-18-P
