Agency Information Collection Activities: Submission for OMB Review; Comment Request, 3471 [E8-879]
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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 This draft
guidance discusses patient-reported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This draft guidance is being issued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The draft guidance, when finalized, will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This draft guidance refers to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
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[Federal Register Volume 73, Number 13 (Friday, January 18, 2008)]
[Notices]
[Page 3471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-879]
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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) 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:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Application respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Waiver Request.................. 20 1 20 6.5 130
-------------------------------------------------------------------------------
Total....................... 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 e-mail 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.''
Dated: January 14, 2008.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E8-879 Filed 1-17-08; 8:45 am]
BILLING CODE 4165-15-P
