Agency Information Collection Activities: Submission for OMB Review; Comment Request, 3469-3470 [E8-909]
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3469
Federal Register / Vol. 73, No. 13 / Friday, January 18, 2008 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form
Parents .......................
Teens ..........................
Parents .......................
Teens ..........................
Parents .......................
Parents .......................
Parent Focus Group Screener ...........................................................
Teen Focus Group Screener ..............................................................
Parent Focus Group Questions ..........................................................
Teen Focus Group Questions ............................................................
Pre/Post Intervention Survey Screener ..............................................
Pre/Post Intervention Survey ..............................................................
Dated: January 9, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers of
Disease Control and Prevention.
[FR Doc. E8–842 Filed 1–17–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10239 and CMS–
R–48]
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
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: New collection; Title of
Information Collection: Conditions of
Participation for Critical Access
Hospitals; Use: With this submission,
we are creating a new information
collection request for critical access
hospitals (CAH). Currently, the
information collection requirements
rwilkins on PROD1PC63 with NOTICES
AGENCY:
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Jkt 214001
associated with the critical access
hospital (CAH) conditions of
participation (CoPs) are included with
the hospital CoPs reported under CMS–
R–48 (0938–0328). Because the CAH
program has grown in scope of services
and the number of providers, we have
removed the CAH burden from the
CMS–R–48 with the exception of the
burden associated with the 101 CAHs
that have distinct part units (DPUs), and
created a separate information
collection request for OMB review and
approval. Section 1820(c)(2)(E)(i) of the
Social Security Act states that if a CAH
operates a distinct part psychiatric or
rehabilitation unit it must have 10 beds
or less in the DPU and it must comply
with the hospital requirements specified
in 42 CFR Subpart A, B, C, and D of part
482. Based on 2007 data from HRSA, 81
CAHs have psychiatric distinct part
units (DPUs) and 20 CAHs have
rehabilitation DPUs. The burden
associated with the 101 CAHs with
DPUs is reported in CMS–R–48. Form
Number: CMS–10239 (OMB#: 0938New); Frequency: Yearly; Affected
Public: Private sector—Business or other
for-profit; Number of Respondents:
1,189; Total Annual Responses:
137,990; Total Annual Hours: 23,291.
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Hospital
Conditions of Participation and
Supporting Regulations in 42 CFR
482.12, 482.13, 482.21, 482.22, 482.23,
482.24, 482.27, 482.30, 482.41, 482.43,
482.45, 482.53, 482.56, 482.57, 482.60,
482.61, 482.62, and 485.616 and
485.631; Use: The information
collection requirements described in
this information collection request are
needed to implement the Medicare and
Medicaid conditions of participation
(CoP) for 4,890 accredited and nonaccredited hospitals and an additional
101 critical access hospitals (CAHs) that
have distinct part psychiatric or
rehabilitation units (DPUs). CAHs that
have DPUs must comply with all of the
hospital CoPs on these units. Thus, this
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70
35
20
10
1800
800
Number of
responses per
respondent
1
1
1
1
1
1
Average
burden per
respondent
(in hours)
1/60
1/60
2
2
1/60
15/60
package reflects the paperwork burden
for a total of 4,991 (that is, 4,890
hospitals and 101 CAHs which include
81 CAHs that have psychiatric DPUs
and 20 CAHs that have rehabilitation
DPUs). The information collection
requirements for the remaining 1,183
CAHs have been reported in a separate
package under CMS–10239.
The CoPs and accompanying
requirements specified in the
regulations are used by our surveyors as
a basis for determining whether a
hospital qualifies for a provider
agreement under Medicare and
Medicaid. CMS and the health care
industry believe that the availability to
the facility of the type of records and
general content of records, which this
regulation specifies, is standard medical
practice and is necessary in order to
ensure the well-being and safety of
patients and professional treatment
accountability. Form Number: CMS–R–
48 (OMB#: 0938–328); Frequency:
Yearly; Affected Public: Private sector—
Business or other for-profit; Number of
Respondents: 4,991; Total Annual
Responses: 1,120,817; Total Annual
Hours: 9,151,200.57.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’s 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 February 19, 2008.
OMB Human Resources and Housing
Branch, Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
E:\FR\FM\18JAN1.SGM
18JAN1
3470
Federal Register / Vol. 73, No. 13 / Friday, January 18, 2008 / Notices
Dated: January 11, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–909 Filed 1–17–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–185]
Agency Information Collection
Activities: Proposed Collection;
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) 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 without change of a
currently approved collection; Title of
Information Collection: Granting and
Withdrawal of Deeming Authority to
Private Nonprofit Accreditation
Organizations and of State Exemption
Under State Laboratory Programs and
Supporting Regulations in 42 CFR
493.551—493.557. Form Number: CMS–
R–185 (OMB# 0938–0686); Frequency:
On occasion; Affected Public: Private
sector—Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 8; Total Annual
Responses: 96; Total Annual Hours:
384.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’s Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
rwilkins on PROD1PC63 with NOTICES
AGENCY:
VerDate Aug<31>2005
16:37 Jan 17, 2008
Jkt 214001
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 March 18, 2008.
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: January 10, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–911 Filed 1–17–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N–0004]
Draft Guidance for Industry on Acute
Bacterial Otitis Media: Developing
Drugs for Treatment; 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 ‘‘Acute Bacterial Otitis
Media: Developing Drugs for
Treatment.’’ The purpose of this draft
guidance is to assist clinical trial
sponsors and investigators in the
development of antimicrobial drug
products for the treatment of acute
bacterial otitis media (ABOM). The
agency’s thinking in this area has
evolved in recent years, and this draft
guidance, when finalized, will inform
sponsors of the changes in our
recommendations. In addition, it will
fulfill a statutory requirement to publish
such a guidance enacted in the Food
and Drug Administration Amendments
Act of 2007 (FDAAA).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by April 17, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
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Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
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 either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: John
Alexander, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 6134, Silver Spring,
MD 20993–0002, 301–796–1400.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Acute Bacterial Otitis Media:
Developing Drugs for Treatment.’’ The
purpose of this draft guidance is to
assist clinical trial sponsors and
investigators in the development of
antimicrobial drug products for the
treatment of ABOM. This guidance
revises the draft guidance regarding
ABOM published in 1998. Section 911
of FDAAA (Public Law 110–85) adds
section 511 to the Federal Food, Drug,
and Cosmetic Act that directs the
Secretary of Health and Human Services
to ‘‘issue guidance for the conduct of
clinical trials with respect to antibiotic
drugs, including antimicrobials to treat
* * * acute bacterial otitis media
* * *.’’ This draft guidance will fulfill
this statutory requirement.
The design of clinical trials for ABOM
was the subject of an Anti-Infective
Drugs Advisory Committee meeting on
July 11, 2002. In addition, other
advisory committee meetings have
focused on the development of specific
drug products for this indication. As a
result of these public discussions, as
well as review of pending applications
at FDA, the agency’s thinking in this
area has evolved in recent years, and
this guidance informs sponsors of the
changes in our recommendations.
Specifically, this draft guidance
recommends that ABOM clinical trials
be designed as superiority rather than
noninferiority trials, and discusses some
possible study designs that might be
employed in an ABOM trial designed to
show superiority. This draft guidance
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Notices]
[Pages 3469-3470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-909]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10239 and CMS-R-48]
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: New collection; Title of
Information Collection: Conditions of Participation for Critical Access
Hospitals; Use: With this submission, we are creating a new information
collection request for critical access hospitals (CAH). Currently, the
information collection requirements associated with the critical access
hospital (CAH) conditions of participation (CoPs) are included with the
hospital CoPs reported under CMS-R-48 (0938-0328). Because the CAH
program has grown in scope of services and the number of providers, we
have removed the CAH burden from the CMS-R-48 with the exception of the
burden associated with the 101 CAHs that have distinct part units
(DPUs), and created a separate information collection request for OMB
review and approval. Section 1820(c)(2)(E)(i) of the Social Security
Act states that if a CAH operates a distinct part psychiatric or
rehabilitation unit it must have 10 beds or less in the DPU and it must
comply with the hospital requirements specified in 42 CFR Subpart A, B,
C, and D of part 482. Based on 2007 data from HRSA, 81 CAHs have
psychiatric distinct part units (DPUs) and 20 CAHs have rehabilitation
DPUs. The burden associated with the 101 CAHs with DPUs is reported in
CMS-R-48. Form Number: CMS-10239 (OMB: 0938-New); Frequency:
Yearly; Affected Public: Private sector--Business or other for-profit;
Number of Respondents: 1,189; Total Annual Responses: 137,990; Total
Annual Hours: 23,291.
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Hospital
Conditions of Participation and Supporting Regulations in 42 CFR
482.12, 482.13, 482.21, 482.22, 482.23, 482.24, 482.27, 482.30, 482.41,
482.43, 482.45, 482.53, 482.56, 482.57, 482.60, 482.61, 482.62, and
485.616 and 485.631; Use: The information collection requirements
described in this information collection request are needed to
implement the Medicare and Medicaid conditions of participation (CoP)
for 4,890 accredited and non-accredited hospitals and an additional 101
critical access hospitals (CAHs) that have distinct part psychiatric or
rehabilitation units (DPUs). CAHs that have DPUs must comply with all
of the hospital CoPs on these units. Thus, this package reflects the
paperwork burden for a total of 4,991 (that is, 4,890 hospitals and 101
CAHs which include 81 CAHs that have psychiatric DPUs and 20 CAHs that
have rehabilitation DPUs). The information collection requirements for
the remaining 1,183 CAHs have been reported in a separate package under
CMS-10239.
The CoPs and accompanying requirements specified in the regulations
are used by our surveyors as a basis for determining whether a hospital
qualifies for a provider agreement under Medicare and Medicaid. CMS and
the health care industry believe that the availability to the facility
of the type of records and general content of records, which this
regulation specifies, is standard medical practice and is necessary in
order to ensure the well-being and safety of patients and professional
treatment accountability. Form Number: CMS-R-48 (OMB: 0938-
328); Frequency: Yearly; Affected Public: Private sector--Business or
other for-profit; Number of Respondents: 4,991; Total Annual Responses:
1,120,817; Total Annual Hours: 9,151,200.57.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS's
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.
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 February 19,
2008.
OMB Human Resources and Housing Branch, Attention: Carolyn Lovett,
New Executive Office Building, Room 10235, Washington, DC 20503, Fax
Number: (202) 395-6974.
[[Page 3470]]
Dated: January 11, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E8-909 Filed 1-17-08; 8:45 am]
BILLING CODE 4120-01-P
