Agency Information Collection Activities: Proposed Collection; Comment Request, 55330-55331 [2010-22593]
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Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
achieving its participation goal and to
respond to inquiries. Respondents are
State Medicaid Agencies. The data is
due April 1 of every year so States need
to have the form and instructions as
soon as possible in order to report
timely. Frequency: Yearly; Affected
Public: State, Tribal and Local
governments; Number of Respondents:
56; Total Annual Responses: 112; Total
Annual Hours: 1,568. (For policy
questions regarding this collection
contact Cindy Ruff at 410–786–5916.
For all other issues call 410–786–1326.)
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 October 12, 2010.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Dated: September 3, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–22592 Filed 9–9–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[Document Identifier: CMS–10207, CMS–
10244, CMS–10343 and CMS–R–131]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare and
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare and Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
srobinson on DSKHWCL6B1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
16:29 Sep 09, 2010
Jkt 220001
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: Physician SelfReferral Exceptions for Electronic
Prescribing and Electronic Health
Records; Use: Section 101 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) directed the Secretary to
create an exception to the physician
self-referral prohibition in section 1877
of the Social Security Act for certain
arrangements in which a physician
receives compensation in the form of
items or services (not including cash or
cash equivalents) (‘‘nonmonetary
remuneration’’) that is necessary and
used solely to receive and transmit
electronic prescription information.
Also, CMS created a separate regulatory
exception for certain arrangements
involving the provision of nonmonetary
remuneration in the form of electronic
health records software or information
technology and training services
necessary and used predominantly to
create, maintain, transmit, or receive
electronic health records.
The conditions for both exceptions
require that arrangements for the items
and services provided must be set forth
in a written agreement, be signed by the
parties involved, specify the items or
services being provided and the cost of
those items or services, and cover all of
the electronic prescribing and/or
electronic health records technology to
be provided by the donating entity. CMS
would use the collected information for
enforcement purposes; specifically, if
we were investigating the financial
relationships between the donors and
the physicians to determine whether the
provisions in the exceptions were met.
Form Number: CMS–10207 (OMB#:
0938–1009); Frequency: Occasionally;
Affected Public: Private Sector: Business
or other for-profits and Not-for-profit
institutions; Number of Respondents:
9,796; Total Annual Responses: 38,959;
Total Annual Hours: 12,451.5. (For
policy questions regarding this
collection contact Kristin Bohl at 410–
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
786–8680. For all other issues call 410–
786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicaid State
Program Integrity Assessment (SPIA);
Use: Under the provisions of the Deficit
Reduction Act (DRA) of 2005, the
Congress directed CMS to establish the
Medicaid Integrity Program (MIP), CMS’
first national strategy to combat
Medicaid fraud, waste, and abuse. CMS
has two broad responsibilities under the
MIP: (1) Reviewing the actions of
individuals or entities providing
services or furnishing items under
Medicaid; conducting audits of claims
submitted for payment; identifying
overpayments; and educating providers
and others on payment integrity and
quality of care; and (2) Providing
effective support and assistance to
States to combat Medicaid fraud, waste,
and abuse.
In order to fulfill the second of these
requirements, CMS developed SPIA.
CMS uses SPIA to collect data on State
Medicaid program integrity activities,
develop reports for each State based on
these data, determine areas to provide
States with technical support and
assistance, and develop measures to
assess States’ performance. Form
Number: CMS–10244 (OMB#: 0938–
1033); Frequency: Annually; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 1,400. (For policy
questions regarding this collection
contact Mary Jo Cook at 410–786–3231.
For all other issues call 410–786–1326.)
3. Type of Information Collection
Request: New collection; Title of
Information Collection: State Plan
Preprint for Medicaid Recovery Audit
Contractors (RACs); Use: Under section
1902(a)(42)(B)(i) of the Social Security
Act, States are required to establish
programs to contract with one or more
Medicaid RACs for the purpose of
identifying underpayments and
recouping overpayments under the State
plan and any waiver of the State plan
with respect to all services for which
payment is made to any entity under
such plan or waiver. Further, the statute
requires States to establish programs to
contract with Medicaid RACs in a
manner consistent with State law, and
generally in the same manner as the
Secretary contracts with Medicare
RACs.
State programs contracted with
Medicaid RACs are not required to be
fully operational until after December
31, 2010. States may submit, to CMS, a
State Plan Amendment (SPA) attesting
E:\FR\FM\10SEN1.SGM
10SEN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
that they will establish a Medicaid RAC
program. States have broad discretion
regarding the Medicaid RAC program
design and the number of entities with
which they elect to contract. Many
States already have experience utilizing
contingency-fee-based Third Party
Liability recovery contractors. Form
Number: CMS–10343 (OMB#: 0938–
NEW); Frequency: Once; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 56. (For policy questions
regarding this collection contact Mary Jo
Cook at 410–786–3231 or Eva Tetteyfio
at 410–786–3653. For all other issues
call 410–786–1326.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Advance
Beneficiary Notice of Noncoverage
(ABN); Use: Under section 1879 of the
Social Security Act, a physician,
provider, practitioner, or supplier of
items or services participating in the
Medicare program, or taking a claim on
assignment, may bill a Medicare
beneficiary for items or services usually
covered under Medicare, but denied in
an individual case under one of the
several statutory exclusions, if they
inform the beneficiary, prior to
furnishing the service, that Medicare is
likely to deny payment. Sections 42 CFR
411.404(b) and (c), and 411.408(d)(2)
and (f), require written notice be
provided to inform beneficiaries in
advance of potential liability for
payment. Form Number: CMS–R–131
(OMB#: 0938–0566); Frequency:
Reporting: Weekly, Monthly, Yearly,
Biennially and Occasionally; Affected
Public: Private Sector: Business or other
for-profits and Not-for-profit
institutions; Number of Respondents:
1,326,282 ; Total Annual Responses:
43,725,850; Total Annual Hours:
5,099,309. (For policy questions
regarding this collection contact Evelyn
Blaemire at 410–786–1803. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
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,
VerDate Mar<15>2010
16:29 Sep 09, 2010
Jkt 220001
comments and recommendations must
be submitted in one of the following
ways by November 9, 2010:
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: September 3, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–22593 Filed 9–9–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0041]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SAPHRIS
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SAPHRIS and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUMMARY:
PO 00000
Frm 00031
Fmt 4703
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55331
The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product SAPHRIS
(asenapine). SAPHRIS is an atypical
antipsychotic indicated for acute
treatment of schizophrenia in adults and
acute treatment of manic or mixed
episodes associated with bipolar I
disorder in adults. Subsequent to this
approval, the Patent and Trademark
Office received a patent term restoration
application for SAPHRIS (U.S. Patent
No. 5,763,476) from NV Organon, and
the Patent and Trademark Office
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
March 3, 2010, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of SAPHRIS represented the
first permitted commercial marketing or
use of the product. Thereafter, the
Patent and Trademark Office requested
that FDA determine the product’s
regulatory review period.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 75, Number 175 (Friday, September 10, 2010)]
[Notices]
[Pages 55330-55331]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22593]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[Document Identifier: CMS-10207, CMS-10244, CMS-10343 and CMS-R-131]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare and Medicaid Services.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare and 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: Physician Self-
Referral Exceptions for Electronic Prescribing and Electronic Health
Records; Use: Section 101 of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 (MMA) directed the Secretary
to create an exception to the physician self-referral prohibition in
section 1877 of the Social Security Act for certain arrangements in
which a physician receives compensation in the form of items or
services (not including cash or cash equivalents) (``nonmonetary
remuneration'') that is necessary and used solely to receive and
transmit electronic prescription information. Also, CMS created a
separate regulatory exception for certain arrangements involving the
provision of nonmonetary remuneration in the form of electronic health
records software or information technology and training services
necessary and used predominantly to create, maintain, transmit, or
receive electronic health records.
The conditions for both exceptions require that arrangements for
the items and services provided must be set forth in a written
agreement, be signed by the parties involved, specify the items or
services being provided and the cost of those items or services, and
cover all of the electronic prescribing and/or electronic health
records technology to be provided by the donating entity. CMS would use
the collected information for enforcement purposes; specifically, if we
were investigating the financial relationships between the donors and
the physicians to determine whether the provisions in the exceptions
were met. Form Number: CMS-10207 (OMB: 0938-1009); Frequency:
Occasionally; Affected Public: Private Sector: Business or other for-
profits and Not-for-profit institutions; Number of Respondents: 9,796;
Total Annual Responses: 38,959; Total Annual Hours: 12,451.5. (For
policy questions regarding this collection contact Kristin Bohl at 410-
786-8680. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Medicaid State
Program Integrity Assessment (SPIA); Use: Under the provisions of the
Deficit Reduction Act (DRA) of 2005, the Congress directed CMS to
establish the Medicaid Integrity Program (MIP), CMS' first national
strategy to combat Medicaid fraud, waste, and abuse. CMS has two broad
responsibilities under the MIP: (1) Reviewing the actions of
individuals or entities providing services or furnishing items under
Medicaid; conducting audits of claims submitted for payment;
identifying overpayments; and educating providers and others on payment
integrity and quality of care; and (2) Providing effective support and
assistance to States to combat Medicaid fraud, waste, and abuse.
In order to fulfill the second of these requirements, CMS developed
SPIA. CMS uses SPIA to collect data on State Medicaid program integrity
activities, develop reports for each State based on these data,
determine areas to provide States with technical support and
assistance, and develop measures to assess States' performance. Form
Number: CMS-10244 (OMB: 0938-1033); Frequency: Annually;
Affected Public: State, Local, or Tribal Governments; Number of
Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 1,400.
(For policy questions regarding this collection contact Mary Jo Cook at
410-786-3231. For all other issues call 410-786-1326.)
3. Type of Information Collection Request: New collection; Title of
Information Collection: State Plan Preprint for Medicaid Recovery Audit
Contractors (RACs); Use: Under section 1902(a)(42)(B)(i) of the Social
Security Act, States are required to establish programs to contract
with one or more Medicaid RACs for the purpose of identifying
underpayments and recouping overpayments under the State plan and any
waiver of the State plan with respect to all services for which payment
is made to any entity under such plan or waiver. Further, the statute
requires States to establish programs to contract with Medicaid RACs in
a manner consistent with State law, and generally in the same manner as
the Secretary contracts with Medicare RACs.
State programs contracted with Medicaid RACs are not required to be
fully operational until after December 31, 2010. States may submit, to
CMS, a State Plan Amendment (SPA) attesting
[[Page 55331]]
that they will establish a Medicaid RAC program. States have broad
discretion regarding the Medicaid RAC program design and the number of
entities with which they elect to contract. Many States already have
experience utilizing contingency-fee-based Third Party Liability
recovery contractors. Form Number: CMS-10343 (OMB: 0938-NEW);
Frequency: Once; Affected Public: State, Local, or Tribal Governments;
Number of Respondents: 56; Total Annual Responses: 56; Total Annual
Hours: 56. (For policy questions regarding this collection contact Mary
Jo Cook at 410-786-3231 or Eva Tetteyfio at 410-786-3653. For all other
issues call 410-786-1326.)
4. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Advance
Beneficiary Notice of Noncoverage (ABN); Use: Under section 1879 of the
Social Security Act, a physician, provider, practitioner, or supplier
of items or services participating in the Medicare program, or taking a
claim on assignment, may bill a Medicare beneficiary for items or
services usually covered under Medicare, but denied in an individual
case under one of the several statutory exclusions, if they inform the
beneficiary, prior to furnishing the service, that Medicare is likely
to deny payment. Sections 42 CFR 411.404(b) and (c), and 411.408(d)(2)
and (f), require written notice be provided to inform beneficiaries in
advance of potential liability for payment. Form Number: CMS-R-131
(OMB: 0938-0566); Frequency: Reporting: Weekly, Monthly,
Yearly, Biennially and Occasionally; Affected Public: Private Sector:
Business or other for-profits and Not-for-profit institutions; Number
of Respondents: 1,326,282 ; Total Annual Responses: 43,725,850; Total
Annual Hours: 5,099,309. (For policy questions regarding this
collection contact Evelyn Blaemire at 410-786-1803. For all other
issues call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web Site 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 November 9, 2010:
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: September 3, 2010.
Martique Jones,
Director, Regulations Development Division-B, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2010-22593 Filed 9-9-10; 8:45 am]
BILLING CODE 4120-01-P
