Agency Information Collection Activities: Proposed Collection; Comment Request, 8878-8879 [E8-2813]
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Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices
under section 402 demonstration waiver
authority. The information to be
obtained as part of the application form
is necessary to document basic
information for physician practices that
intend to participate in this
demonstration initiative. Form Number:
CMS–10165 (OMB#: 0938–0965);
Frequency: Once; Affected Public:
Private sector—Business or other forprofit; Number of Respondents: 2400;
Total Annual Responses: 2400; Total
Annual Hours: 520.
3. Type of Information Collection
Request: New Collection; Title of
Information Collection: State Plan Preprint for Integrated Medicare and
Medicaid Programs; Use: Information
submitted via the State Plan
Amendment (SPA) pre-print will be
used by CMS Central and Regional
Offices to analyze a State’s proposal to
implement integrated Medicare and
Medicaid programs. The pre-print is an
optional document for use by States to
highlight the arrangements between a
State and Medicare Advantage Special
Needs Plans that are also providing
Medicaid services. State Medicaid
Agencies will complete the SPA preprint and submit it to CMS for a
comprehensive analysis. The pre-print
provides the opportunity for States to
confirm that their integrated care model
complies with both Federal statutory
and regulatory requirements. The preprint contains assurances, check-off
items, and areas for States to describe
policies and procedures for subjects
such as enrollment, marketing and
quality assurance. Based on comments
received during the 60-day comment
period, both the instructions and preprint have been revised. Form Numbers:
CMS–10251 (OMB#: 0938–NEW);
Frequency: Reporting—Once; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 30; Total
Annual Hours: 600.
4. Type of Information Collection
Request: Extension of currently
approved collection; Title of
Information Collection: Information
Collection Requirements Contained in
45 CFR Part 162; HIPAA Standards for
Electronic Transactions; Use: This
submission contains information
collection requirements in HCFA–0149–
F, CMS–0003–P, CMS–0005–P, and
CMS–003/005–F. This collection
establishes standards for electronic
transactions and for code sets to be used
in those transactions. The collection
standardizes the approximately 400
formats of electronic health care claims
used in the United States. The use of
these standards significantly reduces the
administrative burden associated with
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paper documents, lowers operating
costs, and improves data quality for
health care providers and health plans;
Form Number: CMS–R–218 (OMB#
0938–0866); Frequency: On occasion;
Affected Public: Business or other forprofit; Number of Respondents:
3,400,000; Total Annual Responses:
3,400,000; Total Annual Hours: 1.
5. Type of Information Collection
Request: New collection; Title of
Information Collection: Certificate of
Destruction for Data Acquired from the
Centers for Medicare and Medicaid
Services; Use: The Certificate of
Destruction will be used by recipients of
CMS data to certify that they have
destroyed the data they have received
through a CMS Data Use Agreement
(DUA). The DUA requires the
destruction of the data at the completion
of the project/expiration of the DUA.
The DUA addresses the conditions
under which CMS will disclose and the
User will maintain CMS data that are
protected by the Privacy Act of 1974,
§ 552a and the Health Insurance
Portability Accountability Act of 1996.
CMS has developed policies and
procedures for such disclosures that are
based on the Privacy Act and the Health
Insurance Portability Act (HIPAA). The
Certificate of Destruction is required to
close out the DUA and to ensure the
data are destroyed and not used for
another purpose. Form Number: CMS–
10252 (OMB# 0938-New); Frequency:
On occasion; Affected Public: Business
or other for-profit; Number of
Respondents: 500; Total Annual
Responses: 500; Total Annual Hours:
84.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, 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 by the OMB desk officer at
the address below, no later than 5 p.m.
on March 17, 2008.
OMB Human Resources and Housing
Branch, Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
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Dated: February 8, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–2804 Filed 2–14–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–267]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
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: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Advantage Program Requirements
Referenced in 42 CFR part 422; Use: The
information collection requirements are
mandated by 42 CFR part 422. Section
4001 of the Balanced Budget Act of 1997
(BBA) added sections 1851 through
1859 to the Social Security Act to
establish this program. The Medicare,
Medicaid, and SCHIP Benefits
Improvement Act and Protection Act of
2000, also added new requirements in
addition to the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003.
Medicare Advantage (MA)
organizations (formerly M+C
organizations) and potential MA
organizations (applicants) use the
information discussed to comply with
the eligibility requirements and the MA
AGENCY:
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Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices
rwilkins on PROD1PC63 with NOTICES
contract requirements. CMS will use
this information to approve contract
applications, monitor compliance with
contract requirements, make proper
payment to MA organizations,
determine compliance with the new
prescription drug benefit requirements
established by the MMA, and to ensure
that correct information is disclosed to
Medicare beneficiaries, both potential
enrollees and enrollees. Form Number:
CMS–R–267 (OMB #0938–0753);
Frequency: Yearly; Affected Public:
Business or other for-profit, and
individuals or households; Number of
Respondents: 9,000,670; Total Annual
Responses: 9,000,670; Total Annual
Hours: 7,711,085.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by April 15, 2008:
1. Electronically. You may submit
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) 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 ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: February 8, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–2813 Filed 2–14–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0077]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; MedWatch: The
Food and Drug Administration Medical
Products Reporting Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. 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 of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the present MedWatch Forms 3500 and
3500A (also known as MedWatch
reporting forms) having an OMB
expiration date of October 31, 2008.
These forms are presently used to report
to the agency about adverse events,
product problems, and medication/
device use errors that occur with FDA
regulated products, including drugs,
biologicals, medical devices, special
nutritional products, dietary
supplements, and non-prescription
(over-the-counter (OTC)) human drug
products marketed without an approved
application.
DATES: Submit written or electronic
comments on the collection of
information by April 15, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1482.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
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8879
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘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 (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
MedWatch: The FDA Medical Products
Reporting Program, Form FDA 3500
and Form FDA 3500A—(OMB Control
Number 0910–0291)—Extension
Under sections 505, 512, 513, 515,
and 903 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 355,
360b, 360c, 360e, and 393), and section
351 of the Public Health Service Act (42
U.S.C. 262), FDA has the responsibility
to ensure the safety and effectiveness of
drugs, biologics, and devices. Under
section 502(a) of the act (21 U.S.C.
352(a)), a drug or device is misbranded
if its labeling is false or misleading.
Under section 502(f)(1) of the act it is
misbranded if it fails to bear adequate
warnings, and under section 502(j), it is
misbranded if it is dangerous to health
when used as directed in its labeling.
Under section 4 of the Dietary
Supplement Health and Education Act
of 1994 (Public Law 103–417), 21 U.S.C.
342 is amended so that FDA must bear
the burden of proof to show a dietary
supplement is unsafe.
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]]>Agencies
[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8878-8879]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2813]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-267]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
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: Extension of a currently
approved collection; Title of Information Collection: Medicare
Advantage Program Requirements Referenced in 42 CFR part 422; Use: The
information collection requirements are mandated by 42 CFR part 422.
Section 4001 of the Balanced Budget Act of 1997 (BBA) added sections
1851 through 1859 to the Social Security Act to establish this program.
The Medicare, Medicaid, and SCHIP Benefits Improvement Act and
Protection Act of 2000, also added new requirements in addition to the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
Medicare Advantage (MA) organizations (formerly M+C organizations)
and potential MA organizations (applicants) use the information
discussed to comply with the eligibility requirements and the MA
[[Page 8879]]
contract requirements. CMS will use this information to approve
contract applications, monitor compliance with contract requirements,
make proper payment to MA organizations, determine compliance with the
new prescription drug benefit requirements established by the MMA, and
to ensure that correct information is disclosed to Medicare
beneficiaries, both potential enrollees and enrollees. Form Number:
CMS-R-267 (OMB 0938-0753); Frequency: Yearly; Affected Public:
Business or other for-profit, and individuals or households; Number of
Respondents: 9,000,670; Total Annual Responses: 9,000,670; Total Annual
Hours: 7,711,085.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995,
or E-mail your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by April 15, 2008:
1. Electronically. You may submit 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) 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.
Dated: February 8, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E8-2813 Filed 2-14-08; 8:45 am]
BILLING CODE 4120-01-P
