Draft Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability, 3470-3471 [E8-835]
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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
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
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
3471
Federal Register / Vol. 73, No. 13 / Friday, January 18, 2008 / Notices
also recommends that microbiological
information be obtained in at least one
of the controlled studies. This draft
guidance discusses patient-reported
outcome instruments for assessing
clinical response, and the use of time to
resolution as a possible approach to
assessing the primary endpoint in
clinical studies.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on developing drugs for the treatment of
acute bacterial otitis media. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that in January 2008, the
FDA Web site is expected to transition
to the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. After the transition
date, electronic submissions will be
accepted by FDA through the FDMS
only. When the exact date of the
transition to FDMS is known, FDA will
publish a Federal Register notice
announcing that date.
II. The Paperwork Reduction Act of
1995
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 312 have been approved under
0910–0014; the collections of
information in 21 CFR part 314 have
been approved under 0910–0001; and
the collections of information referred to
in the guidance Establishment and
Operation of Clinical Trial Data
Monitoring Committees have been
approved under 0910–0581.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Dated: January 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–835 Filed 1–17–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
Number of
respondents
Application
Responses
per respondent
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301)–443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Ryan White HIV/
AIDS Program Core Medical Services
Waiver Application Requirements
(OMB No. 0915–0307): Extension
Title XXVI of the Public Health
Service (PHS) Act, as amended by the
Ryan White HIV/AIDS Treatment
Modernization Act of 2006 (Ryan White
HIV/AIDS Program) requires that
grantees expend 75 percent of Parts A,
B, and C funds on core medical services,
including antiretroviral drugs, for
individuals with HIV/AIDS identified
and eligible under the legislation,
effective fiscal year 2007. In order for
grantees under Parts A, B, and C to be
exempted from the 75 percent core
medical services requirement, they must
request and receive a waiver from
HRSA, as required in the Act.
Grantees must submit a waiver
request with the annual grant
application containing the information
and documentation which will be
utilized by HRSA in making
determinations regarding waiver
requests.
The estimated annual burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
20
1
20
6.5
130
Total ..............................................................................
rwilkins on PROD1PC63 with NOTICES
Waiver Request ...................................................................
20
........................
20
........................
130
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
VerDate Aug<31>2005
16:37 Jan 17, 2008
Jkt 214001
Dated: January 14, 2008.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E8–879 Filed 1–17–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4165–15–P
National Human Genome Research
Institute; Notice of Closed Meetings
PO 00000
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
Frm 00024
Fmt 4703
Sfmt 4703
E:\FR\FM\18JAN1.SGM
18JAN1
]]>Agencies
[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Notices]
[Pages 3470-3471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-835]
-----------------------------------------------------------------------
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 Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed 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
[[Page 3471]]
also recommends that microbiological information be obtained in at
least one of the controlled studies. This draft guidance discusses
patient-reported outcome instruments for assessing clinical response,
and the use of time to resolution as a possible approach to assessing
the primary endpoint in clinical studies.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on developing
drugs for the treatment of acute bacterial otitis media. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.
II. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR part 312 have been approved
under 0910-0014; the collections of information in 21 CFR part 314 have
been approved under 0910-0001; and the collections of information
referred to in the guidance Establishment and Operation of Clinical
Trial Data Monitoring Committees have been approved under 0910-0581.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://
www.fda.gov/ohrms/dockets/default.htm.
Dated: January 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-835 Filed 1-17-08; 8:45 am]
BILLING CODE 4160-01-S
