Agency Information Collection Activities: Submission for OMB Review; Comment Request, 26639-26640 [E7-9011]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices
Dated: May 4, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9056 Filed 5–9–07; 8:45 am]
Path Programs (HF–18), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7864.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Protecting the Rights, Safety, and
Welfare of Study Subjects—Supervisory
Responsibilities of Investigators.’’ Under
the regulations in part 312 (21 CFR part
312) (Investigational New Drug
Application) and part 812 (21 CFR part
812) (Investigational Device
Exemptions), an investigator is
responsible for ensuring that a clinical
investigation is conducted according to
the signed investigator statement, the
investigational plan, and applicable
regulations; for protecting the rights,
safety, and welfare of subjects under the
investigator’s care; and for the control of
drugs, biological products, and devices
under investigation (§§ 312.60 and
812.100). This draft guidance clarifies
the responsibilities of investigators in
the conduct of clinical investigations
conducted under parts 312 and 812,
particularly the responsibilities to
supervise the conduct of the clinical
investigation, and to protect the rights,
safety, and welfare of study participants
in drug, biologic, and medical device
clinical trials. The draft guidance also
provides recommendations on how
investigators should supervise the
study-related actions of persons not in
the direct employ of the investigator,
including certain study staff and parties
conducting associated testing and
assessments.
This draft guidance is being issued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The draft guidance, when finalized, will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 the supervisory responsibilities of
investigators. 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0173]
Draft Guidance for Industry on
Protecting the Rights, Safety, and
Welfare of Study Subjects—
Supervisory Responsibilities of
Investigators; Availability
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Protecting the Rights,
Safety, and Welfare of Study Subjects—
Supervisory Responsibilities of
Investigators.’’ This draft guidance is
intended to assist investigators in
meeting their responsibilities with
respect to protecting human subjects
and ensuring the integrity of data in the
conduct of clinical investigations. The
draft guidance also clarifies FDA’s
expectations concerning the
investigator’s responsibility for
supervising a clinical study in which
some study tasks are delegated to
employees of the investigator or to
outside parties.
DATES: Submit written or electronic
comments on the draft guidance by July
9, 2007. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Critical Path Programs (HF–
18), Office of the Commissioner, 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 telephone requests to 800–835–
4709 or 301–827–1800. 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 https://www.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Terrie L. Crescenzi, Office of Critical
VerDate Aug<31>2005
15:04 May 09, 2007
Jkt 211001
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in part 312 have been
approved under OMB Control No. 0910–
0014; and the collections of information
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
26639
in part 812 have been approved under
OMB Control No. 0910–0078.
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm orhttps://www.fda.gov/ohrms/
dockets/default.htm.
Dated: May 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9055 Filed 5–9–07; 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: Women’s Physical
Activity and Healthy Eating Tools
Assessment: NEW
The HRSA Office of Women’s Health
(OWH) developed the Bright Futures for
Women’s Health and Wellness
(BFWHW) Initiative to help expand the
scope of women’s preventive health
activities, particularly related to
nutrition and physical activity. An
intermediate assessment of the BFWHW
E:\FR\FM\10MYN1.SGM
10MYN1
26640
Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices
health promotion consumer materials
related to physical activity and healthy
eating will be conducted in order to
assess how the BFWHW materials can
stimulate a conversation on physical
activity and healthy eating during a
clinical encounter, inform future
BFWHW programming, and add to the
peer-reviewed literature regarding
women’s health and wellness
initiatives.
Towards this end, anonymous
assessment forms will be used to collect
data from young and adult women
clients, health care providers, and
administrators of health centers. Data
collected will include process and
outcome measures. Data domains
include: the distribution and use of the
materials in the health care setting
during wellness and health
maintenance/check-up visits; client and
provider awareness of physical activity
and nutrition behaviors; attitudes about
the importance of physical activity and
nutrition; self-efficacy; and increase in
knowledge and intent to change
physical activity and nutrition
behaviors.
A total of six organizations, which
may include Federally Qualified Health
Centers/Community Health Centers,
faith-based organizations that offer
health care services, worksite health
centers, and school-based health clinics,
will be selected for the study. Young
women will complete anonymous
assessment forms at school-based health
centers; adult women will be assessed at
other health care organizations. The
providers at these sites will also be
asked to complete a brief one-time
anonymous assessment form. Telephone
interviews will be conducted with an
administrator of each of these sites as
well. The data collection period at each
site is estimated to last four months. The
estimated response burden is as follows:
Estimated Data Collection Burden Hours
Data collection activity
Number of
respondents
Responses
per
respondent
Hours per
response
Hourly wage
rate
Total burden
hours
Total cost
Clients ....................................................
Administrators ........................................
Support Staff ..........................................
Providers ................................................
3,000
6
6
60
.81
4.22
63.67
5.98
1
1
1
1
2,430
25
382
359
$5.15
37.09
13.65
59.15
$12,514.50
927.25
5,214.30
21,234.85
Total ................................................
3,072
..........................
........................
3,196
........................
39,890.90
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to:
Karen Matsuoka, Human Resources and
Housing Branch, Office of Management
and Budget, New Executive Office
Building, Room 10235, Washington, DC
20503.
Dated: May 4, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7–9011 Filed 5–9–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
pwalker on PROD1PC71 with NOTICES
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law (Pub. L.) 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
VerDate Aug<31>2005
15:04 May 09, 2007
Jkt 211001
To request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on 301–443–1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Children’s Hospital
Graduate Medical Education Payment
Program (CHGME PP) Annual Report:
NEW
The CHGME PP was enacted by Pub.
L. 106–129 to provide Federal support
for graduate medical education (GME) to
freestanding children’s hospitals,
similar to Medicare GME support
received by other, non-children’s
hospitals. The legislation indicates that
eligible children’s hospitals will receive
payments for both direct and indirect
medical education. Direct payments are
designed to offset the expenses
associated with operating approved
graduate medical residency training
programs and indirect payments are
designed to compensate hospitals for
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
expenses associated with the treatment
of more severely ill patients and the
additional costs relating to teaching
residents in such programs.
The CHGME PP was reauthorized for
a period of five years in October 2006
by Pub. L. 109–307. The reauthorizing
legislation requires that participating
children’s hospitals provide information
about their residency training programs
in an annual report that will be an
addendum to the hospitals’ annual
applications for funds.
Data are required to be collected on:
(1) The types of training programs that
the hospital provided for residents such
as general pediatrics, internal medicine/
pediatrics, and pediatric subspecialties
including both medical subspecialties
certified and non-medical
subspecialties; (2) the number of
training positions for residents, the
number of such positions recruited to
fill, and the number of positions filled;
(3) the types of training that the hospital
provided for residents related to the
health care needs of different
populations such as children who are
underserved for reasons of family
income or geographic location,
including rural and urban areas; (4) the
changes in residency training including
changes in curricula, training
experiences, and types of training
programs, and benefits that have
resulted from such changes and changes
for purposes of training residents in the
measurement and improvement and the
quality and safety of patient care; and
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 72, Number 90 (Thursday, May 10, 2007)]
[Notices]
[Pages 26639-26640]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9011]
-----------------------------------------------------------------------
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: Women's Physical Activity and Healthy Eating Tools
Assessment: NEW
The HRSA Office of Women's Health (OWH) developed the Bright
Futures for Women's Health and Wellness (BFWHW) Initiative to help
expand the scope of women's preventive health activities, particularly
related to nutrition and physical activity. An intermediate assessment
of the BFWHW
[[Page 26640]]
health promotion consumer materials related to physical activity and
healthy eating will be conducted in order to assess how the BFWHW
materials can stimulate a conversation on physical activity and healthy
eating during a clinical encounter, inform future BFWHW programming,
and add to the peer-reviewed literature regarding women's health and
wellness initiatives.
Towards this end, anonymous assessment forms will be used to
collect data from young and adult women clients, health care providers,
and administrators of health centers. Data collected will include
process and outcome measures. Data domains include: the distribution
and use of the materials in the health care setting during wellness and
health maintenance/check-up visits; client and provider awareness of
physical activity and nutrition behaviors; attitudes about the
importance of physical activity and nutrition; self-efficacy; and
increase in knowledge and intent to change physical activity and
nutrition behaviors.
A total of six organizations, which may include Federally Qualified
Health Centers/Community Health Centers, faith-based organizations that
offer health care services, worksite health centers, and school-based
health clinics, will be selected for the study. Young women will
complete anonymous assessment forms at school-based health centers;
adult women will be assessed at other health care organizations. The
providers at these sites will also be asked to complete a brief one-
time anonymous assessment form. Telephone interviews will be conducted
with an administrator of each of these sites as well. The data
collection period at each site is estimated to last four months. The
estimated response burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Data Collection Burden Hours
---------------------------------------------------------------- Hourly wage
Data collection activity Number of Hours per Responses per Total burden rate Total cost
respondents response respondent hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clients................................................. 3,000 .81 1 2,430 $5.15 $12,514.50
Administrators.......................................... 6 4.22 1 25 37.09 927.25
Support Staff........................................... 6 63.67 1 382 13.65 5,214.30
Providers............................................... 60 5.98 1 359 59.15 21,234.85
-----------------------------------------------------------------------------------------------
Total............................................... 3,072 .............. .............. 3,196 .............. 39,890.90
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
Karen Matsuoka, Human Resources and Housing Branch, Office of
Management and Budget, New Executive Office Building, Room 10235,
Washington, DC 20503.
Dated: May 4, 2007.
Caroline Lewis,
Associate Administrator for Management.
[FR Doc. E7-9011 Filed 5-9-07; 8:45 am]
BILLING CODE 4165-15-P
