Agency Information Collection Activities: Submission for OMB Review; Comment Request, 17094-17095 [05-6534]
Download as PDF
<![CDATA[
17094
Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices
randomly sampled as part of the CERT
process; Frequency: On occasion;
Affected Public: Business or other forprofit; Number of Respondents: 1600;
Total Annual Responses: 1600; Total
Annual Hours: 454.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Participating Physician or Supplier
Agreement; Form No.: CMS–460 (OMB#
0938–0373); Use: Form number CMS–
460 is completed by nonparticipating
physicians and suppliers if they choose
to participate in Medicare Part B. By
signing the agreement, the physician or
supplier agrees to take assignment on all
Medicare claims. To take assignment
means to accept the Medicare allowed
amount as payment in full for the
services they furnish and to charge the
beneficiary no more than the deductible
and coinsurance for the covered service.
In exchange for signing the agreement,
the physician or supplier receives a
significant number of program benefits
not available to nonparticipating
suppliers. The information associated
with this collection is needed to identify
the recipients of the program benefits;
Frequency: Other—when starting a new
business; Affected Public: Business or
other for-profit; Number of
Respondents: 6000; Total Annual
Responses: 6000; Total Annual Hours:
1500.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Information
Collection Requirements in Final Peer
Review Organization Regulations, 42
CFR Sections 1004.40, 1004.50, 1004.60,
1004.70; Form No.: CMS–R–65 (OMB#
0938–0444); Use: This final rule updates
the procedures governing the imposition
and adjudication of program sanctions
predicated on the recommendations of
Peer Review Organizations (PROs).
These changes are being made as a
result of statutory revisions designed to
address health care fraud and abuse
issues in the OIG sanction process. The
Peer Review Improvement Act of 1982
amended Title XI of the Social Security
Act, creating the Utilization and Quality
Control Peer Review Organization
program. Section 1156 of the Social
Security Act imposes obligations on
health care practitioners and other
persons who furnish or order services or
items under Medicare. This section also
provides for sanction actions, if the
Secretary determines that the
obligations as stated by this section are
not met. Quality Improvement
Organizations (QIOs) are responsible for
identifying violations. QIOs may allow
VerDate jul<14>2003
15:19 Apr 01, 2005
Jkt 205001
practitioners or other persons,
opportunities to submit relevant
information before determining that a
violation has occurred. These
requirements are used by the QIOs to
collect the information necessary to
make their determinations; Frequency:
On occasion; Affected Public: Not-forprofit institutions; Number of
Respondents: 53; Total Annual
Responses: 1060; Total Annual Hours:
22,684.
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/
regulations/pra/, 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.
Written comments and
recommendations for the proposed
information collections must be mailed
within 60 days of this notice directly to
the CMS Paperwork Reduction Act
Reports Clearance Officer designated at
the address below:
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attention:
William N. Parham, III, Room C5–13–
27, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: March 24, 2005.
John P. Burke, III,
CMS Paperwork Reduction Act Reports
Clearance Officer, Office of Strategic
Operations and Regulatory Affairs,
Regulations Development Group.
[FR Doc. 05–6533 Filed 4–1–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10008]
Agency Information Collection
Activities: Submission for OMB
Review; 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), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
AGENCY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 function;
(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:
Revision of a currently approved
collection; Title of Information
Collection: Process and Information
Required to Determine Eligibility of
Drugs, Biologicals, and Radiopharmaceutical Agents for Transitional
Pass-Through Provisions Under the
Hospital Outpatient Prospective
Payment System (OPPS) and Supporting
Regulations in 42 CFR, Section 419.43;
Use: Section 1833(t)(6) of the Social
Security Act provides for temporary
additional payments or ‘‘transitional
pass-through payments’’ for certain
drugs and biological agents. Interested
parties such as hospitals,
pharmaceutical companies, and
physicians can apply for transitional
pass-through payment for drugs and
biologicals used with services covered
under the OPPS. CMS uses this
information to determine if the criteria
for making a transitional pass-through
payment are met and if an interim
HCPCS code for a new drug or
biological is necessary. The revisions
made to this collection include the
addition of Section 303 of the MMA.
This new section establishes the use of
the average sales price (ASP)
methodology for payment; Form
Number: CMS–10008 (OMB# 0938–
0802); Frequency: On occasion; Affected
Public: Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 58; Total Annual
Responses: 58; Total Annual Hours:
203.
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/
regulations/pra/, 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.
Written comments and
recommendations for the proposed
information collections must be mailed
within 30 days of this notice directly to
the OMB desk officer: OMB Human
E:\FR\FM\04APN1.SGM
04APN1
Federal Register / Vol. 70, No. 63 / Monday, April 4, 2005 / Notices
Resources and Housing Branch,
Attention: Christopher Martin, New
Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: March 24, 2005.
John P. Burke, III,
CMS Paperwork Reduction Act Reports
Clearance Officer, Office of Strategic
Operations and Regulatory Affairs,
Regulations Development Group.
[FR Doc. 05–6534 Filed 4–1–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0112]
Draft Guidance for Industry on Clinical
Trial Endpoints for the Approval of
Cancer Drugs and Biologics;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Clinical Trial
Endpoints for the Approval of Cancer
Drugs and Biologics.’’
This is the first of a series of
guidances that will provide
recommendations to sponsors on
endpoints for cancer clinical trials
submitted to FDA to support
effectiveness claims in new drug
applications (NDAs), biologics license
applications (BLAs), or supplemental
applications. Sponsors are encouraged
to use this draft guidance to design
cancer clinical trials and to discuss
protocols with the agency. This draft
guidance provides background
information and discusses general
regulatory principles. Each subsequent
guidance will focus on endpoints for
specific cancer types (e.g., lung cancer,
colon cancer) to support drug approval
or labeling claims. These guidances are
expected to speed the development and
improve the quality of protocols
submitted to the agency to support
anticancer effectiveness claims.
DATES: Submit written or electronic
comments on the draft guidance by June
3, 2005. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
VerDate jul<14>2003
15:19 Apr 01, 2005
Jkt 205001
Administration, 5600 Fishers Lane,
Rockville, MD 20857, or the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
The draft guidance may also be obtained
by mail by calling the Center for
Biologics Evaluation and Research
Voice Information System at 1–800–
835–4709 or 301–827–1800. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Grant Williams, Center for Drug
Evaluation and Research (HFD–
150), Food and Drug
Administration, 1451 Rockville
Pike, Rockville, MD 20852, 301–
594–5758;
Patricia Keegan, Center for Drug
Evaluation and Research (HFD–
107), Food and Drug
Administration, 1451 Rockville
Pike, Rockville, MD 20852, 301–
827–5097; or
Steven Hirschfeld, Center for
Biologics Evaluation and Research
(HFM–755), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301–
827–6536.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Clinical Trial Endpoints for the
Approval of Cancer Drugs and
Biologics.’’ FDA is developing guidance
on oncology endpoints through a
process that includes public workshops
of oncology experts and discussions
before FDA’s Oncologic Drugs Advisory
Committee. This draft guidance is the
first in a planned series of cancer
endpoint guidances. It provides
background information and general
principles. The endpoints discussed in
this draft guidance are for drugs to treat
patients with an existing cancer. This
draft guidance does not address
endpoints for drugs to prevent or
decrease the incidence of cancer.
This draft guidance is being issued
consistent with FDA’s good guidance
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
17095
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on clinical trial endpoints for the
approval of cancer drugs and biologics.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
one copy of electronic comments or two
paper copies of any mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. The draft guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: March 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–6647 Filed 4–1–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Data Collection; Comment
Request; Survey of Colorectal Cancer
Screening Policies, Programs, and
Systems in U.S. Health Plans
SUMMARY: In compliance with the
provisions of section 3507(1)(D) of the
Paperwork Reduction Act of 1995, for
opportunity for public comments on
proposed data collection projects, the
National Institutes of Health (NIH),
National Cancer Institute (NCI) has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on October 29,
2004 (Volume 69, No. 209, pages 63159–
63160) and allowed 60 days for public
E:\FR\FM\04APN1.SGM
04APN1
]]>Agencies
[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Pages 17094-17095]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10008]
Agency Information Collection Activities: Submission for OMB
Review; 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), Department of Health and Human Services, 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 function; (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: Revision of a currently approved
collection; Title of Information Collection: Process and Information
Required to Determine Eligibility of Drugs, Biologicals, and Radio-
pharmaceutical Agents for Transitional Pass-Through Provisions Under
the Hospital Outpatient Prospective Payment System (OPPS) and
Supporting Regulations in 42 CFR, Section 419.43; Use: Section
1833(t)(6) of the Social Security Act provides for temporary additional
payments or ``transitional pass-through payments'' for certain drugs
and biological agents. Interested parties such as hospitals,
pharmaceutical companies, and physicians can apply for transitional
pass-through payment for drugs and biologicals used with services
covered under the OPPS. CMS uses this information to determine if the
criteria for making a transitional pass-through payment are met and if
an interim HCPCS code for a new drug or biological is necessary. The
revisions made to this collection include the addition of Section 303
of the MMA. This new section establishes the use of the average sales
price (ASP) methodology for payment; Form Number: CMS-10008
(OMB 0938-0802); Frequency: On occasion; Affected Public:
Business or other for-profit and Not-for-profit institutions; Number of
Respondents: 58; Total Annual Responses: 58; Total Annual Hours: 203.
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/regulations/pra/, 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.
Written comments and recommendations for the proposed information
collections must be mailed within 30 days of this notice directly to
the OMB desk officer: OMB Human
[[Page 17095]]
Resources and Housing Branch, Attention: Christopher Martin, New
Executive Office Building, Room 10235, Washington, DC 20503.
Dated: March 24, 2005.
John P. Burke, III,
CMS Paperwork Reduction Act Reports Clearance Officer, Office of
Strategic Operations and Regulatory Affairs, Regulations Development
Group.
[FR Doc. 05-6534 Filed 4-1-05; 8:45 am]
BILLING CODE 4120-01-P
