Agency Information Collection Activities: Proposed Collection; Comment Request, 70653 [E8-27711]
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Federal Register / Vol. 73, No. 226 / Friday, November 21, 2008 / Notices
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research, quality
improvement and information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: November 6, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–27523 Filed 11–20–08; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–416]
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
dwashington3 on PRODPC61 with NOTICES
AGENCY:
VerDate Aug<31>2005
14:24 Nov 20, 2008
Jkt 217001
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: Revision of a currently
approved collection; Title of
Information Collection: Annual Early
and Periodic Screening, Diagnostic and
Treatment (EPSDT) Report; Use: States
are required to submit an annual report
on the provision of EPSDT services
pursuant to section 1902(a)(43)(D) of the
Social Security Act. These reports
provide CMS with data necessary to
assess the effectiveness of State EPSDT
programs, to determine a State’s results
in achieving its participation goal and to
respond to inquiries. This collection is
being submitted as a revision based on
minor changes made to the form and
instructions. CMS has added three
additional lines of data to the form
(lines 12d, 12e and 12f). This
information is currently being collected;
however, CMS expanded the lines to
obtain a better understanding for the
utilization of dental services. CMS
believes there will be no additional
burden for the changes made to the
form. The changes were necessary to
accommodate a need for more specific
dental data and to preliminary notify
States of a change in CPT codes. A
clarification was also made to line 14 of
the instructions. Form Number: CMS–
416 (OMB# 0938–0354); Frequency:
Yearly; Affected Public: State, Local or
Tribal Governments; Number of
Respondents: 56; Total Annual
Responses: 56; Total Annual Hours:
1,568.
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,
comments and recommendations must
be submitted in one of the following
ways by January 20, 2009:
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.
PO 00000
Frm 00042
Fmt 4703
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70653
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: November 14, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–27711 Filed 11–20–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0029]
Determination That NUBAIN
(Nalbuphine Hydrochloride) Injection,
10 and 20 Milligrams/Milliliter, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that NUBAIN
(nalbuphine hydrochloride) injection,
10 and 20 milligrams/milliliter (mg/ml),
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for nalbuphine
hydrochloride injection, 10 and 20 mg/
ml, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Carol E. Drew, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[Federal Register Volume 73, Number 226 (Friday, November 21, 2008)]
[Notices]
[Page 70653]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27711]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-416]
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: Revision of a currently
approved collection; Title of Information Collection: Annual Early and
Periodic Screening, Diagnostic and Treatment (EPSDT) Report; Use:
States are required to submit an annual report on the provision of
EPSDT services pursuant to section 1902(a)(43)(D) of the Social
Security Act. These reports provide CMS with data necessary to assess
the effectiveness of State EPSDT programs, to determine a State's
results in achieving its participation goal and to respond to
inquiries. This collection is being submitted as a revision based on
minor changes made to the form and instructions. CMS has added three
additional lines of data to the form (lines 12d, 12e and 12f). This
information is currently being collected; however, CMS expanded the
lines to obtain a better understanding for the utilization of dental
services. CMS believes there will be no additional burden for the
changes made to the form. The changes were necessary to accommodate a
need for more specific dental data and to preliminary notify States of
a change in CPT codes. A clarification was also made to line 14 of the
instructions. Form Number: CMS-416 (OMB 0938-0354); Frequency:
Yearly; Affected Public: State, Local or Tribal Governments; Number of
Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 1,568.
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 January 20, 2009:
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: November 14, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E8-27711 Filed 11-20-08; 8:45 am]
BILLING CODE 4120-01-P
