Published 60-day FR

18658

Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–4040–0005] [30Day Notice]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed collection for public
comment. Interested persons are invited
to send comments regarding this 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.
Type of Information Collection
Request: Revision.
Title of Information Collection: SF–
424 Individual.
Form/OMB No.: OS–4040–0005.
Use: The SF–424 (individual) is a
simplified, alternative government-wide
data set and application cover page for
use by Federal grant-making agencies
that award grants to individuals. The
form will include one change to one
field—the Social Security Number
(SSN). The SSN field will remain
optional. The SSN field will be changed
to pre-populate the first five digits with
‘‘000–00–’’ The applicant will only
enter the last four digits of the SSN.
This change ensures the entire SSN will
not be collected or stored. This change
will not increase the collection burden
to the applicant.
Frequency: Recordkeeping on
Occasion.
Affected Public: Individuals or
Households.
Annual Number of Respondents:
5827.
Total Annual Responses: 6949.
Average Burden per Response: 25
minutes.
Total Annual Hours: 2895.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections

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referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
[email protected] , or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be
received within 30 days of this notice
directly to the Desk Officer at the
address below:
OMB Desk Officer: John Kraemer,
OMB Human Resources and Housing
Branch, Attention: (OMB #4040–0005),
New Executive Office Building, Room
10235, Washington, DC 20503.
Dated: April 5, 2007.
Mary Oliver-Anderson,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. E7–7004 Filed 4–12–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10227, CMS–
1561 and 1561A, CMS–2728, CMS–10221,
CMS–R–290, and CMS–R–26]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this 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.
1. Type of Information Collection
Request: Existing collection in use
without an OMB Control Number; Title
of Information Collection: PACE State
Plan Amendment Pre-print; Form
Number: CMS–10227 (OMB#: 0938–

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New); Use: The Balanced Budget Act of
1997 created section 1934 of the Social
Security Act that established the
Program for the All-Inclusive Care for
the Elderly (PACE). The legislation
established the PACE program as a
Medicaid State plan option serving the
frail and elderly in the home and
community. In accordance with the rule
published in the November 24, 1999
Federal Register (64 FR 66271), if a
State elects to offer PACE as an optional
Medicaid benefit, it must complete a
State Plan Amendment described as
Enclosures #3, 4, 5, 6 and 7. In State
Medicaid Director letters dated March
23, 1998 and November 9, 2000, CMS
advised States that it had provided a
suggested pre-print and supplemental
pages for a State to express its intention
to elect PACE as an option to its State
plans. As pre-print packet Enclosures
#3–7 were suggested and not required,
CMS did not believe at the time that a
suggested form required clearance from
OMB. The PACE regulation 42 CFR part
460 was first published in the Federal
Register as an interim final rule on
November 24, 1999. The final PACE rule
was published on December 8, 2006.
CMS is seeking OMB approval to use
Enclosures #3, 4, 5, 6 and 7. The
information is used by CMS to affirm
that the State elects to offer PACE an
optional State plan service and the
specifications of eligibility, payment
and enrollment for the program;
Frequency: Reporting—Once; Affected
Public: State, Local or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56 possible
responses but we have only received 20
thus far; Total Annual Hours: 1,120.
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Health
Insurance Benefit Agreement and
Supporting Regulations at 42 CFR 489;
Form Numbers: CMS–1561 and 1561A
(OMB#: 0938–0832); Use: Applicants to
the Medicare program are required to
agree to provide services in accordance
with Federal requirements. The CMS–
1561 and 1561A are essential for CMS
to ensure that applicants are in
compliance with the requirements.
Applicants will be required to sign the
completed form and provide operational
information to CMS to assure that they
continue to meet the requirements after
approval; Frequency: Reporting—Other:
all new applicants must complete;
Affected Public: State, Local or Tribal
Governments, Business or Other for
profit and Not-for-profit institutions;
Number of Respondents: 3300; Total

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Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices
Annual Responses: 3300; Total Annual
Hours: 275.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: End Stage Renal
Disease Medical Evidence Report
Medicare Entitlement and/or Patient
Registration; Form Number: CMS–2728
(OMB#: 0938–0046); Use: The End Stage
Renal Disease Medical Evidence (CMS–
2728) is completed for all ESRD patients
either by the first treatment facility or by
a Medicare-approved ESRD facility
when it is determined by a physician
that the patient’s condition has reached
that stage of renal impairment that a
regular course of kidney dialysis or a
kidney transplant is necessary to
maintain life.
The data reported on the CMS–2728
is used by the Federal Government,
ESRD Networks, treatment facilities,
researchers and others to monitor and
assess the quality and type of care
provided to end stage renal
beneficiaries. The data collection
captures the specific medical
information required to determine the
Medicare medical eligibility of End
Stage Renal Disease claimants. It also
collects data for research and policy on
this population. Frequency: Reporting—
Once; Affected Public: Individuals or
households, Business or other-for-profit,
Not-for-profit institutions; Number of
Respondents: 100,000; Total Annual
Responses: 100,000; Total Annual
Hours: 75,000.
4. Type of Information Collection
Request: New collection; Title of
Information Collection: Worksheet for
Recording Results of Medicare Site
Visits of Independent Diagnostic Testing
Facilities (IDTFs) Form; Form Number:
CMS–10221 (OMB#: 0938–New); Use:
Prior to enrolling in Medicare,
independent diagnostic testing facilities
(IDTFs) must undergo a site visit as
required under 42 CFR 410.33. The
purpose of the site visit is to ensure that
the IDTF is in compliance with the
provisions of 42 CFR 410.33, as well as
all other applicable Federal, State and
local laws and regulations. It is also
used to verify the information the IDTF
furnished on its CMS–855B enrollment
application.
Section 410.33 contains a significant
number of standards that IDTFs must
meet in order to enroll in Medicare.
Compliance with the standards further
ensures that only qualified and
legitimate IDTFs can bill Medicare. This
is especially important in light of
concerns about recent fraudulent
activity by some IDTFs. We are
submitting the ‘‘Worksheet for
Recording Results of Medicare Site

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Visits of Independent Diagnostic Testing
Facilities (IDTFs),’’ for OMB approval.
The purpose of this document is to
ensure that the individuals performing
IDTF site visits take into account both
new and existing IDTF standards in a
consistent fashion. Frequency:
Reporting—On occasion; Affected
Public: Business or other-for-profit, Notfor-profit institutions; Number of
Respondents: 2,000; Total Annual
Responses: 2,000; Total Annual Hours:
4,000.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Program: Process for Making National
Coverage Determinations; Form
Number: CMS–R–290 (OMB#: 0938–
0776); Use: On September 26, 2003 (68
FR 55634), we published a notice that
described how we revised the process
we use to make Medicare coverage
decisions including decisions regarding
whether new technology and services
can be covered. In accordance with
section IV.B of the aforementioned
notice, CMS’ Revised Process for
Making National Coverage
Determinations, we require an
individual or entity to make a formal
request for a national coverage
determination. Upon receipt of a formal
request and adequate supporting
documentation, we will make a
determination based on the evidence
presented, to cover the device or service
or not to cover the device or service
where it is not supported by the medical
evidence. We are resubmitting this
information collection request (ICR) to
the Office of Management and Budget as
an extension of the currently approved
collection. We have not made any
material modifications to the ICR since
the last submission. Frequency:
Recordkeeping and Reporting—On
occasion; Affected Public: Business or
other-for-profit, Not-for-profit
institutions; Number of Respondents:
200; Total Annual Responses: 200; Total
Annual Hours: 8,000.
6. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Information
Collection Requirements (ICRs)
Contained in the Clinical Laboratory
Improvement Amendments (CLIA)
Regulations 42 CFR part 493.801,
493.803, 493.1232, 493.1233, 493.1234,
493.1235, 493.1236, 493.1239, 493.1241,
493.1242, 493.1249, 493.1251, 493.1252,
439.1253, 493.1254, 493.1255, 493.1256,
493.1261, 493.1262, 493.1263, 493.1269,
493.1273, 493.1274, 493.1278, 493.1283,
493.1289, 493.1291, and 493.1299; Form
Numbers: CMS–R–26 (OMB#: 0938–

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18659

0612); Use: The ICRs referenced in 42
CFR part 493 outline the requirements
necessary to determine an entity’s
complicance with CLIA. CLIA requires
laboratories that perform testing on
human beings to meet performance
requirements (quality standards) in
order to be certified by the Department
of Health and Human Services (HHS).
HHS conducts inspections to determine
a laboratory’s compliance with CLIA
requirements. CLIA implements the
certificate, laboratory standards and
inspection requirements; Frequency:
Reporting—As needed; Affected Public:
State, Local or Tribal Governments,
Federal Government, Business or Other
for profit and Not-for-profit institutions;
Number of Respondents: 168,688; Total
Annual Responses: 756,241; Total
Annual Hours: 11,363,680.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at http://www.cms.hhs.gov/
PaperworkReductionActof1995, or
E-mail your request, including your
address, phone number, OMB number,
and CMS document identifier to
[email protected], or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on June 12, 2007.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—A,
Attention: Melissa Musotto, Room C4–
26–05, 7500 Security Boulevard,
Baltimore, Maryland 21244–1850.
Dated: April 6, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–6990 Filed 4–12–07; 8:45 am]
BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0015]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adoption of the
Food and Drug Administration Food
Code by Local, State, and Tribal
Governments
AGENCY:

Food and Drug Administration,

HHS.

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