Agency Information Collection Activities: Submission for OMB Review; Comment Request, 42346-42347 [05-14484]
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Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices
Notice of this meeting is given under
the Federal Advisory committee Act (5
U.S.C. app. 2).
Dated: July 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–14455 Filed 7–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D–0492] (formerly Docket
No. 02D–0492)
Guidance for Industry on Estimating
the Maximum Safe Starting Dose in
Initial Clinical Trials for Therapeutics in
Adult Healthy Volunteers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Estimating the Maximum Safe
Starting Dose in Initial Clinical Trials
for Therapeutics in Adult Healthy
Volunteers.’’ This guidance provides a
description and basis for a process by
which to select a maximum
recommended starting dose (MRSD) for
a first-in-human clinical trial of a
therapeutic in adult healthy volunteers.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this 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 selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
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 https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: Lois
M. Freed, Center for Drug Evaluation
and Research (HFD–120), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2647.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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19:28 Jul 21, 2005
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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Estimating the Maximum Safe Starting
Dose in Initial Clinical Trials for
Therapeutics in Adult Healthy
Volunteers.’’ This guidance provides a
description and basis for a process by
which to select an MRSD for a first-inhuman clinical trial of a new molecular
entity in adult healthy volunteers. In the
Federal Register of January 16, 2003 (68
FR 2340), FDA published a notice
making available a draft guidance
entitled ‘‘Estimating the Safe Starting
Dose in Clinical Trials for Therapeutics
in Adult Healthy Volunteers.’’ The
notice gave interested persons an
opportunity to submit comments. As a
result of the comments, certain sections
of this guidance were reworded to
improve clarity. The guidance outlines
a recommended standardized approach
(including common conversion factors
for calculating human equivalent doses)
and vocabulary for selecting an MRSD
based on animal data, and discusses
factors to be considered in determining
reasonable safety margins. This
approach is applicable to a first-inhuman trial of a new drug or biological
therapeutic, regardless of intended
clinical use. The guidance also
discusses alternative approaches and
provides some examples of
circumstances under which alternative
approaches for selection of an MRSD
should be considered. Dose escalation is
not addressed.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on estimating the
maximum safe starting dose in initial
clinical trials for therapeutics in adult
healthy volunteers. 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
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. The guidance
and received comments are available for
public examination in the Division of
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Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either http:/
/www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: July 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14456 Filed 7–21–05; 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)
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: The National Health
Service Corps Uniform Data System
(OMB No. 0915–0232): Revision
The National Health Service Corps
(NHSC) of the Bureau of Health
Professions (BHPr), Health Resources
and Services Administration (HRSA), is
committed to improving the health of
the Nation’s underserved by uniting
communities in need with caring health
professionals and by supporting
communities’ efforts to build better
systems of care.
The NHSC needs to collect data on its
programs to ensure compliance with
legislative mandates and to report to
Congress and policymakers on program
accomplishments. To meet these
objectives, the NHSC requires a core set
of information collected annually that is
appropriate for monitoring and
evaluating performance and reporting
on annual trends. The following
information will be collected from each
site: services offered and delivery
method; users by various characteristics;
staffing and utilization; charges and
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Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices
collections; receivables, income, and
expenses; and managed care.
The estimated burden is as follows:
Number of
respondents
Type of report
Universal Report ..............................................................................................
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
John Kraemer, Desk Officer, Human
Resources and Housing Branch, Office
of Management and Budget, New
Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: July 15, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–14484 Filed 7–21–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (DHHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as amended 68 FR 787–93, January 7,
2003; as amended at 68 FR 8515–8517,
February 21, 2003, as last amended 69
FR 56433–56445, September 21, 2004.)
This notice reflects several revisions
to the organizational and functional
statements of the Bureau of Primary
Health Care. Specifically, this notice (1)
Renames the Division of Health Center
Development to the Division of Policy
and Development; (2) Moves the policy
function from the Office of the Director;
(3) Establishes the Policy Branch in the
Division of Policy and Development;
and (4) Establishes a new description for
the Division Director.
Section RC–00 Mission
The Bureau of Primary Health Care
(BPHC) directs national health programs
which improve the health of the Nation
by assuring access to high quality
comprehensive preventive and primary
health care services and improving the
health status of the Nation’s
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1200
underserved and vulnerable
populations.
Section RC–10 Organization
The Bureau of Primary Health Care
(BPHC) headed by the Associate
Administrator for Primary Health Care
reports directly to the Administrator,
Health Resources and Services
Administration. BPHC includes the
following components:
(1) Office of the Associate
Administrator (RC)
(2) Office of Minority and Special
Populations (RCE)
(3) Division of Policy and
Development (RCH)
(4) Division of Health Center
Management (RCJ)
(5) Division of Clinical Quality (RCK)
(6) Division of State and Community
Assistance (RCL)
(7) Division of National Hansen’s
Disease Program (RC7)
(8) Division of Immigration Health
Services (RC9)
Remove the policy function from the
Office of the Associate Administrator
and place it in the Division of Policy
and Development; and change the
functional statement as follows: The
Division of Policy and Development
(RCH) serves as the organizational focus
of the competitive grant process for
BPHC; and leads in drafting policy and
conducting analyses of performance
across BPHC’s programs. Specifically,
the Division of Policy and Development
executes the following activities: (1)
Leads and monitors the development
and expansion of health centers and
health systems infrastructure; (2)
provides pre-application assistance to
communities and community-based
organizations related to the
development and expansion of health
centers and health systems
infrastructure; (3) consults and
coordinates with other components
within HRSA, other Federal agencies,
consumer and constituency groups, and
national and State organizations on
issues affecting BPHC’s programs; (4)
formulates budget justifications for
BPHC’s programs and provides input
into the analysis of BPHC budget
execution; (5) leads and coordinates the
analysis, development and drafting of
policy impacting BPHC’s programs; (6)
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Responses
per respondent
1
Hours per
response
Total burden
hours
27
32,400
performs environmental scanning on
issues that affect BPHC’s programs; (7)
serves as the focal point for designing
and implementing a plan for assessing
and improving program performance;
and (8) serves as the focal point for
monitoring BPHC’s activities in relation
to HRSA’s Strategic Plan.
Revise the functional statement for
the Office of the Associate
Administrator as follows: Provides
overall leadership, direction,
coordination, and strategic planning in
support of Bureau programs.
Specifically: (1) Has lead responsibility
to bring primary health care services to
the Nation’s neediest communities; (2)
serves as a central point of contact for
Bureau communication and
information; (3) establishes program
policies, goals, and objectives and
provides oversight as to their execution;
(4) interprets program policies,
guidelines, and priorities; (5) stimulates,
coordinates and evaluates program
development and progress; (6)
maintains effective relationships with
HRSA, other Department and Health
and Human Services (HHS)
organizations, other Federal agencies,
State and local governments, and other
public and private organizations
concerned with primary health and
improving the health status of the
Nation’s underserved and vulnerable
populations; and (7) plans, directs,
coordinates and evaluates Bureau-wide
administrative management activities;
(8) assures BPHC’s funding
recommendations are consistent with
authorizing legislation, program
expectations and HHS and HRSA
policies.
Section RC–30 Delegation of Authority
All delegations of authority which
were in effect immediately prior to the
effective date hereof have been
continued in effect in them or their
successors pending further redelegation. I hereby ratify and affirm all
actions taken by any HHS official which
involves the exercise of these authorities
prior to the effective date of this
delegation.
This reorganization is effective upon
the date of signature.
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]]>Agencies
[Federal Register Volume 70, Number 140 (Friday, July 22, 2005)]
[Notices]
[Pages 42346-42347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14484]
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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: The National Health Service Corps Uniform Data System
(OMB No. 0915-0232): Revision
The National Health Service Corps (NHSC) of the Bureau of Health
Professions (BHPr), Health Resources and Services Administration
(HRSA), is committed to improving the health of the Nation's
underserved by uniting communities in need with caring health
professionals and by supporting communities' efforts to build better
systems of care.
The NHSC needs to collect data on its programs to ensure compliance
with legislative mandates and to report to Congress and policymakers on
program accomplishments. To meet these objectives, the NHSC requires a
core set of information collected annually that is appropriate for
monitoring and evaluating performance and reporting on annual trends.
The following information will be collected from each site: services
offered and delivery method; users by various characteristics; staffing
and utilization; charges and
[[Page 42347]]
collections; receivables, income, and expenses; and managed care.
The estimated burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
Type of report respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Universal Report................................ 1200 1 27 32,400
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
John Kraemer, Desk Officer, Human Resources and Housing Branch, Office
of Management and Budget, New Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: July 15, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-14484 Filed 7-21-05; 8:45 am]
BILLING CODE 4165-15-P
