Agency Information Collection Activities: Proposed Collection; Comment Request, 3470 [E8-911]
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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
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AGENCY:
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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
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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]
[Page 3470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-185]
Agency Information Collection Activities: Proposed Collection;
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) 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 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 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
