Agency Information Collection Activities: Submission for OMB Review; Comment Request, 34939-34940 [E6-9479]
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Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
program, covering program savings,
reductions in cost sharing, impacts on
access to and quality of affected goods
and services, and beneficiary
satisfaction. This project’s purpose is to
provide information for this Report to
Congress. Form Number: CMS–10197
(OMB#: 0938–-New); Frequency:
Reporting—Other: Baseline and Followup; Affected Public: Individuals or
Households, Business or other for-profit,
Federal Government and Not-for-profit
institutions; Number of Respondents:
12,671; Total Annual Responses:
12,671; Total Annual Hours: 6,557.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare Part D
Reporting Requirements and Supporting
Regulations under 42 CFR 423.505; Use:
Data collected via Medicare Part D
Reporting Requirements will be an
integral resource for oversight,
monitoring, compliance and auditing
activities necessary to ensure quality
provision of the Medicare Prescription
Drug Benefit to beneficiaries. Data will
be validated, analyzed, and utilized for
trend reporting by CMS. If outliers or
other data anomalies are detected, CMS
will work in collaboration with other
CMS divisions for follow-up and
resolution. Form Number: CMS–10185
(OMB#: 0938–0992); Frequency:
Reporting: Quarterly and Semiannually; Affected Public: Business or
other for-profit; Number of
Respondents: 3,203; Total Annual
Responses: 12,812; Total Annual Hours:
102,496.
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: End Stage Renal
Disease (ESRD) Network Semi-Annual
Cost Report Forms and Supporting
Regulations in 42 CFR 405.2110 and 42
CFR 405.2112; Use: Section 1881(c) of
the Social Security Act establishes End
Stage Renal Disease (ESRD) Network
contracts. The regulations designated at
42 CFR 405.2110 and 405.2112
designated 18 ESRD Networks which
are funded by renewable contracts.
These contracts are on 3-year cycles. To
better administer the program, CMS is
requiring contractors to submit semiannual cost reports. The purpose of the
cost reports is to enable the ESRD
Networks to report costs in a
standardized manner. This will allow
CMS to review, compare and project
ESRD Network costs during the life of
the contract. Form Number: CMS–685
(OMB#: 0938–0657); Frequency:
Reporting—Semi-annually; Affected
Public: Not-for-profit institutions;
Number of Respondents: 18; Total
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Annual Responses: 36; Total Annual
Hours: 108.
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 at the address below, no
later than 5 p.m. on August 15, 2006.
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: June 9, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–9478 Filed 6–15–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–194 and
CMS–R–52]
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
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
AGENCY:
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34939
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
Disproportionate Share Adjustment
Procedures and Criteria and Supporting
Regulations in 42 CFR 412.106; Use: A
hospital’s disproportionate share
adjustment is determined by its fiscal
intermediary (FI) using a combination of
Medicare Part A and Supplemental
Security Income data provided by CMS,
and Medicaid data calculated from the
hospital’s cost report. The data provided
through these calculations are then
compared to the qualifying criteria
located in 42 CFR 412.106 to determine
the final adjustment. If these
calculations, based on the Federal fiscal
year, do not allow the hospital to qualify
for a disproportionate share adjustment,
the hospital may request that the
calculations be performed using its cost
reporting period; Form Number: CMS–
R–194 (OMB#: 0938–0691); Frequency:
Recordkeeping and Reporting—On
occasion; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
100; Total Annual Responses: 100; Total
Annual Hours: 100.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Conditions for
Coverage of Suppliers of End Stage
Renal Disease (ESRD) Services and
Supporting Regulations Contained in 42
CFR 405.2100–405.2171; Use: The
requirements associated with the
Medicare and Medicaid Conditions for
Coverage for Suppliers of ESRD Services
fall into two categories: record keeping
requirements and reporting
requirements. With regard to the
recordkeeping requirements, CMS uses
these conditions for coverage to certify
health care facilities that want to
participate in the Medicare or Medicaid
programs. These record keeping
requirements are no different than other
conditions for coverage in that they
reflect comparable standards developed
by industry organizations such as the
Renal Physicians Association, American
Society of Transplant Surgeons, and the
National Association of Patients on
Hemodialysis and Transplantation.
With respect to reporting requirements,
the information is needed to assess and
ensure proper distribution and effective
utilization of ESRD treatment resources
while maintaining or improving quality
of care. It is CMS’s responsibility to
closely monitor ESRD service utilization
to prevent over-expansion of facilities
E:\FR\FM\16JNN1.SGM
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34940
Federal Register / Vol. 71, No. 116 / Friday, June 16, 2006 / Notices
and resultant under-utilization; Form
Number: CMS–R–52 (OMB#: 0938–
0386); Frequency: Recordkeeping and
Reporting—Annually; Affected Public:
Business or other for-profit and Federal
government; Number of Respondents:
4,757; Total Annual Responses: 4,757;
Total Annual Hours: 160,702.
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.
Written comments and
recommendations for the proposed
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Application No.
Washington, DC 20503. Fax Number:
(202) 395–6974.
Dated: June 9, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–9479 Filed 6–15–06; 8:45 am]
BILLING CODE 4120–01–P
approval of 65 new drug applications
(NDAs) and 52 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0222]
Merck & Co., Inc., et al.; Withdrawal of
Approval of 65 New Drug Applications
and 52 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
Effective June 16, 2006.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
The
holders of the applications listed in the
table in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications. The applicants have also,
by their requests, waived their
opportunity for a hearing.
SUPPLEMENTARY INFORMATION:
Drug
Applicant
Vitamin B6 (pyridoxine hydrochloride (HCl))
Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, BLA–20,
West Point, PA 19486–0004
NDA 5–521
Heparin Sodium Injection USP
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 5–657
Tubocurarine Chloride Injection USP
Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543–
4500
NDA 5–794
Sultrin Triple Sulfa Cream and Triple Sulfa Tablets
Ortho-McNeil Pharmaceutical, Inc., 1000 U.S. Highway 202,
P.O. Box 300, Raritan, NJ 08869–0602
NDA 6–012
Folvron (folic acid and iron)
Lederle Laboratories, 401 North Middleton Rd., Pearl River, NY
10965
NDA 7–149
Rubramin (cyanocobalamin) Tablets and Capsules
Bristol-Myers Squibb Co.
NDA 7–504
Acthar (corticotropin for injection)
Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., BX 2–309E,
Bridgewater, NJ 08807
NDA 7–794
Neothylline (dyphylline)
Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090,
North Wales, PA 19454
NDA 9–176
Cortril (hydrocortisone) Topical Ointment
Pfizer Global Pharmaceuticals, 235 East 42nd St., New York,
NY 10017
NDA 10–028
Equanil (meprobamate) Tablets
Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA
19101–8299
NDA 10–093
Biphetamine (dextroamphetamine and amphetamine)
Capsules
Celltech Pharmaceuticals, Inc., 755 Jefferson Rd., P.O. Box
31710, Rochester, NY 14603
NDA 10–513
Ketonil (amino acids and electrolytes)
Merck & Co., Inc.
NDA 10–787
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NDA 1–645
Iron Dextran Injection
Aventis Pharmaceuticals, Inc.
NDA 10–799
Dimetane (brompheniramine maleate) Tablets and
Extendtabs
Wyeth Consumer Healthcare, 5 Giralda Farms, Madison, NJ
07940
NDA 11–340
Cerumenex (triethanolamine polypeptide oleate-condensate), 10%
The Purdue Frederick Co., 1 Stamford Forum, Stamford, CT
06901–3431
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]]>Agencies
[Federal Register Volume 71, Number 116 (Friday, June 16, 2006)]
[Notices]
[Pages 34939-34940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9479]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-194 and CMS-R-52]
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 Request: Extension of a currently
approved collection; Title of Information Collection: Medicare
Disproportionate Share Adjustment Procedures and Criteria and
Supporting Regulations in 42 CFR 412.106; Use: A hospital's
disproportionate share adjustment is determined by its fiscal
intermediary (FI) using a combination of Medicare Part A and
Supplemental Security Income data provided by CMS, and Medicaid data
calculated from the hospital's cost report. The data provided through
these calculations are then compared to the qualifying criteria located
in 42 CFR 412.106 to determine the final adjustment. If these
calculations, based on the Federal fiscal year, do not allow the
hospital to qualify for a disproportionate share adjustment, the
hospital may request that the calculations be performed using its cost
reporting period; Form Number: CMS-R-194 (OMB: 0938-0691);
Frequency: Recordkeeping and Reporting--On occasion; Affected Public:
Business or other for-profit and Not-for-profit institutions; Number of
Respondents: 100; Total Annual Responses: 100; Total Annual Hours: 100.
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Conditions for
Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and
Supporting Regulations Contained in 42 CFR 405.2100-405.2171; Use: The
requirements associated with the Medicare and Medicaid Conditions for
Coverage for Suppliers of ESRD Services fall into two categories:
record keeping requirements and reporting requirements. With regard to
the recordkeeping requirements, CMS uses these conditions for coverage
to certify health care facilities that want to participate in the
Medicare or Medicaid programs. These record keeping requirements are no
different than other conditions for coverage in that they reflect
comparable standards developed by industry organizations such as the
Renal Physicians Association, American Society of Transplant Surgeons,
and the National Association of Patients on Hemodialysis and
Transplantation. With respect to reporting requirements, the
information is needed to assess and ensure proper distribution and
effective utilization of ESRD treatment resources while maintaining or
improving quality of care. It is CMS's responsibility to closely
monitor ESRD service utilization to prevent over-expansion of
facilities
[[Page 34940]]
and resultant under-utilization; Form Number: CMS-R-52 (OMB:
0938-0386); Frequency: Recordkeeping and Reporting--Annually; Affected
Public: Business or other for-profit and Federal government; Number of
Respondents: 4,757; Total Annual Responses: 4,757; Total Annual Hours:
160,702.
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.
Written comments and recommendations for the proposed information
collections must be mailed or faxed within 30 days of this notice
directly to the OMB desk officer: OMB Human Resources and Housing
Branch, Attention: Carolyn Lovett, New Executive Office Building, Room
10235, Washington, DC 20503. Fax Number: (202) 395-6974.
Dated: June 9, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E6-9479 Filed 6-15-06; 8:45 am]
BILLING CODE 4120-01-P
