Agency Information Collection Activities: Proposed Collection; Comment Request, 69975-69976 [05-22906]
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Federal Register / Vol. 70, No. 222 / Friday, November 18, 2005 / Notices
certain individuals described in the
statute as: (1) Undocumented aliens; (2)
aliens who have been paroled into the
United States at a United States port of
entry for the purpose of receiving
eligible services; and (3) Mexican
citizens permitted to enter the United
States for not more than 30 days under
the authority of a biometric machine
readable border crossing identification
card (also referred to as a ‘‘laser visa’’)
issued in accordance with the
requirements of regulations prescribed
under a specific section of the
Immigration and Nationality Act as
published in the Bureau of Customs and
Border Protection’s interim final rule
dated August 13, 2004.; Frequency:
Other—as needed; Affected Public:
Business or other for-profit, Not-forprofit institutions, and State, Local or
Tribal Governments; Number of
Respondents: 7,503,000; Total Annual
Responses: 7,512,000; Total Annual
Hours: 634,000.
2. Type of Information Collection
Request: New Collection; Title of
Information Collection: Electronic Data
Interchange (EDI) Enrollment Form and
Centers for Medicare and Medicaid
Services EDI Registration Form; Form
No.: CMS–10164 (OMB # 0938–NEW);
Use: CMS is requiring that providers
who wish to conduct Electronic Data
Interchange (EDI) transactions,
specifically the HIPAA Eligibility
Inquiry and Response (270/271) directly
with CMS at the Baltimore data center,
provide certain information related to
their organization and/or organizations
conducting EDI business on their behalf.
Health care providers, clearinghouses,
and health plans that wish to access the
Medicare system for the purposes of
conducting other EDI business
transactions are also required to
complete this form. Furthermore, CMS
has incorporated changes to the
collection as a result of public
comments. One specific comment
resulted in the combining of the
information collected related to
Medicare Modernization Act (MMA)
section 1011 and Medicare Fee-For
Service Part A and Part B. Both
programs collect similar information for
the purposes of provider enrollment and
trading partner profile information
related to the exchange of EDI
transactions. To further reduce the
burden on providers enrolling in either
the MMA section 1011 and/or the
Medicare Fee-For Service program the
CMS–10164 collection will change
terms from ‘‘Carrier/FI’’ to ‘‘Medicare
contractor’’. The purpose is to
generically refer to the organization that
CMS contracts with to operate the
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15:21 Nov 17, 2005
Jkt 208001
specific program function such as MMA
section 1011 or Medicare Part A,
Medicare Part B for a specific
jurisdiction. The information will be
used to assure that profile data for those
entities that access the section 1011
and/or Medicare system are entered
appropriately. Frequency:
Recordkeeping and Reporting—Other
(As-Needed); Affected Public: Business
or other for-profit, Not-for-profit
institutions; Number of Respondents:
1,220,000; Total Annual Responses:
1,220,000; Total Annual Hours: 400,000.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Retiree Drug
Subsidy (RDS) Application and
Instructions; Form Number: CMS’10156
(OMB#: 0938’’ 0957); Use: Under the
Medicare Prescription Drug,
Improvement, and Modernization Act
(MMA) of 2003 and implementing
regulations at 42 CFR subpart R plan
sponsors (employers,unions) who offer
prescription drug coverage to their
qualified covered retirees are eligible to
receive a 28% taxfree subsidy for
allowable drug costs. In order to qualify,
plan sponsors must submit a complete
application to CMS with a list of retirees
for whom it intends to collect the
subsidy; Frequency: Quarterly, Monthly,
Annually; Affected Public: Business or
other for-profit, Not-for-profit
institutions, Federal, State, local and/or
tribal Government; Number of
Respondents: 50,000; Total Annual
Responses: 50,000; Total Annual Hours:
2,025,000.
To obtain copies of the supporting
statement and any related forms for
these 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.
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 December 19, 2005. OMB Human
Resources and Housing Branch,
Attention: Carolyn Lovett, CMS Desk
Officer,New Executive Office Building,
Room 10235,Washington, DC 20503.
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
69975
Dated: November 9, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–22904 Filed 11–17–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10173, CMS–
437A and CMS–437B]
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: New Collection; Title of
Information Collection: Individuals
Authorized Access to the CMS
Computer Services; Form Number:
CMS–10173 (OMB#: 0938–NEW); Use:
The Centers for Medicare and Medicaid
Services (CMS) is requesting the Office
of Management and Budget (OMB)
approval of the Individuals Authorized
to Customer Service Application for
Access to CMS Computer Systems. CMS
has planned to provide a centralized
user provisioning and administration
service that supports the creation,
deletion, and lifecycle management of
enterprise identities. This service
creates accounts, supports Role Based
Access Control (RBAC), the form flow
approval process and enterprise identity
audit and recertification, and provides
business application integration points.
An application integration point allows
AGENCY:
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69976
Federal Register / Vol. 70, No. 222 / Friday, November 18, 2005 / Notices
business application owners to use the
form flow process of the user
provisioning service to approve or deny
requests for access to business
applications. The primary purpose of
this system is to implement a unified
framework for managing user
information and access rights, for those
individuals who apply for and are
granted access across multiple CMS
systems and business contexts.
Information in this system will also be
used to: (1) Support regulatory and
policy functions performed within the
Agency or by a contractor or consultant;
(2) support constituent requests made to
a Congressional representative; and (3)
to support litigation involving the
Agency related to this system. We have
provided background information about
the proposed system in the
‘‘Supplementary Information’’ section
below. Although the Privacy Act
requires only that the ‘‘routine use’’
portion of the system be published for
comment, CMS invites comments on all
portions of this notice. See ‘‘Effective
Dates’’ section for comment period;
Frequency: Other—As required;
Affected Public: Business or other-forprofit, Individuals or Households, Notfor-profit institutions, Federal
government, and State, Local, or Tribal
Government; Number of Respondents:
60,000,000; Total Annual Responses:
60,000,000; Total Annual Hours:
15,000,000.
2. Type of Information Collection
Request: New Collection; Title of
Information Collection: Rehabilitation
Unit Criteria Work Sheet and
Rehabilitation Hospital Criteria Work
Sheet and Supporting Regulations at 42
CFR 488.26; Form Number: CMS–437A
and CMS–437B (OMB#: 0938–NEW—
NOTE: These instruments are currently
approved under 0938–0358 but are
being carved out into a separate
collection as they are updated more
frequently.); Use: The rehabilitation
hospital and rehabilitation unit criteria
work sheets are necessary to verify that
these facilities/units comply and remain
in compliance with the exclusion
criteria for the Medicare prospective
payment system; Frequency: Annually;
Affected Public: Business or other-forprofit, Not-for-profit institutions, and
State, Local, or Tribal Government;
Number of Respondents: 1227; Total
Annual Responses: 1227; Total Annual
Hours: 306.75.
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,
VerDate Aug<31>2005
15:21 Nov 17, 2005
Jkt 208001
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 January 17, 2006.
CMS, Office of Strategic Operations and
Regulatory Affairs, Division of
Regulations Development, Attention:
William N. Parham, III, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: November 9, 2005.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 05–22906 Filed 11–17–05; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005P–0305]
Request for Comment on the Status of
Pyridoxamine
AGENCY:
Food and Drug Administration,
HHS.
Notice of opportunity to
comment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that comments related to the status of
pyridoxamine may be submitted until
December 19, 2005. FDA is requesting
comments in response to the submission
of a citizen petition requesting, among
other things, that the agency determine
the status of pyridoxamine. All
comments postmarked on or before
December 19, 2005 will be accepted as
part of the official record for this matter.
DATES: Submit written comments by
December 19, 2005.
ADDRESSES: Submit written comments
on the status of pyridoxamine 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.
FOR FURTHER INFORMATION CONTACT:
Robert Moore, Center for Food Safety
and Applied Nutrition (HFS–810), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1441.
SUPPLEMENTARY INFORMATION: On July
29, 2005, FDA received a citizen
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
petition submitted, under 21 CFR 10.30,
by the law firm Morgan Lewis &
Bockius, LLP, on behalf of BioStratum,
Inc. The petition requests that the
agency: (1) State in writing that dietary
supplements that contain pyridoxamine
are adulterated under the Federal Food,
Drug, and Cosmetic Act; (2) exercise its
enforcement authority under the act to
remove from interstate commerce
dietary supplements containing
pyridoxamine; and (3) not place this
citizen petition in the agency’s docket
for premarket notifications for new
dietary ingredients (Docket No. 2004N–
0454).
In its citizen petition, BioStratum,
Inc., states, among other things, that it
is the manufacturer of Pyridorin
(pyridoxamine dihydrochloride), which
is the subject of an investigational new
drug application (IND) that was filed
with FDA in July 1999 for use as a
potential therapeutic agent to slow or
prevent the progression of diabetic
nephropathy in patients with type 1 and
type 2 diabetes. The petition further
states that substantial clinical trials have
been conducted for this drug and that
the existence of those studies has been
made public. In addition, the petition
states that pyridoxamine was not
marketed as a dietary supplement or as
a food prior to Pyridorin’s authorization
for investigation as a new drug under an
IND.
FDA has considered the information
and legal argument set forth in the
petition. Based on the facts set forth in
the petition, the agency tentatively
concludes that pyridoxamine, the active
moiety1 of pyridoxamine
dihydrochloride, is excluded from the
dietary supplement definition under the
exclusion clause in 21 U.S.C.
321(ff)(3)(B)(ii) and therefore may not be
marketed as or in a dietary supplement.
However, although the petition asserts
that there is no evidence that
pyridoxamine was marketed as a dietary
ingredient or as a food prior to the
authorization of Pyridorin for
investigation under an IND, the agency
is interested in receiving information, if
any, that bears on pyridoxamine’s prior
marketing as a dietary ingredient or as
a food, as well as other information that
would inform the agency’s final
decision on the status of pyridoxamine.
1 Under 21 CFR 316.3(b)(2), ‘‘active moiety’’
means the molecule or ion, excluding those
appended portions of the molecule that cause the
drug to be an ester, salt (including a salt with
hydrogen or coordination bonds), or other
noncovalent derivative (such as a complex, chelate,
or clathrate) of the molecule, responsible for the
physiological or pharmacological action of the drug
substance.
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 70, Number 222 (Friday, November 18, 2005)]
[Notices]
[Pages 69975-69976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22906]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10173, CMS-437A and CMS-437B]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: 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: New Collection; Title of
Information Collection: Individuals Authorized Access to the CMS
Computer Services; Form Number: CMS-10173 (OMB: 0938-NEW);
Use: The Centers for Medicare and Medicaid Services (CMS) is requesting
the Office of Management and Budget (OMB) approval of the Individuals
Authorized to Customer Service Application for Access to CMS Computer
Systems. CMS has planned to provide a centralized user provisioning and
administration service that supports the creation, deletion, and
lifecycle management of enterprise identities. This service creates
accounts, supports Role Based Access Control (RBAC), the form flow
approval process and enterprise identity audit and recertification, and
provides business application integration points. An application
integration point allows
[[Page 69976]]
business application owners to use the form flow process of the user
provisioning service to approve or deny requests for access to business
applications. The primary purpose of this system is to implement a
unified framework for managing user information and access rights, for
those individuals who apply for and are granted access across multiple
CMS systems and business contexts. Information in this system will also
be used to: (1) Support regulatory and policy functions performed
within the Agency or by a contractor or consultant; (2) support
constituent requests made to a Congressional representative; and (3) to
support litigation involving the Agency related to this system. We have
provided background information about the proposed system in the
``Supplementary Information'' section below. Although the Privacy Act
requires only that the ``routine use'' portion of the system be
published for comment, CMS invites comments on all portions of this
notice. See ``Effective Dates'' section for comment period; Frequency:
Other--As required; Affected Public: Business or other-for-profit,
Individuals or Households, Not-for-profit institutions, Federal
government, and State, Local, or Tribal Government; Number of
Respondents: 60,000,000; Total Annual Responses: 60,000,000; Total
Annual Hours: 15,000,000.
2. Type of Information Collection Request: New Collection; Title of
Information Collection: Rehabilitation Unit Criteria Work Sheet and
Rehabilitation Hospital Criteria Work Sheet and Supporting Regulations
at 42 CFR 488.26; Form Number: CMS-437A and CMS-437B (OMB:
0938-NEW--NOTE: These instruments are currently approved under 0938-
0358 but are being carved out into a separate collection as they are
updated more frequently.); Use: The rehabilitation hospital and
rehabilitation unit criteria work sheets are necessary to verify that
these facilities/units comply and remain in compliance with the
exclusion criteria for the Medicare prospective payment system;
Frequency: Annually; Affected Public: Business or other-for-profit,
Not-for-profit institutions, and State, Local, or Tribal Government;
Number of Respondents: 1227; Total Annual Responses: 1227; Total Annual
Hours: 306.75.
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.
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 January 17, 2006. CMS, Office of Strategic
Operations and Regulatory Affairs, Division of Regulations Development,
Attention: William N. Parham, III, Room C4-26-05, 7500 Security
Boulevard, Baltimore, Maryland 21244-1850.
Dated: November 9, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 05-22906 Filed 11-17-05; 8:45 am]
BILLING CODE 4120-01-P
