Submission for OMB Approval; Comment Request; Extension of Approved Collection; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought, 42 CFR Part 50, Subpart F and for Responsible Prospective Contractors, 45 CFR Part 94 C, 57365-57366 [E8-23171]
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Federal Register / Vol. 73, No. 192 / Thursday, October 2, 2008 / Notices
provide services to underserved and
vulnerable populations. The NHSC
Uniform Data System report (UDS) is
completed by sites that receive the
placement of an NHSC provider, if those
sites are not currently receiving HRSA
grant support. The NHSC UDS provides
information that is utilized for
monitoring and evaluation of program
operations and effectiveness, and to
57365
accurately report on the scope of
supported activities.
The estimated annual burden is as
follows:
Instrument
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Uniform Data System ...........................................................
1,200
1
1,200
27
32,400
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.’’
Dated: September 26, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–23222 Filed 10–1–08; 8:45 am]
BILLING CODE 4165–15–P
Health Resources and Services
Administration
BILLING CODE 4165–15–P
National Advisory Council on Migrant
Health; Notice of Meeting
mstockstill on PROD1PC66 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
Migrant Health.
Dates and Times: November 18, 2008, 8:30
a.m. to 5 p.m.; November 19, 2008, 8:30 a.m.
to 5 p.m.
Place: Sheraton New Orleans Hotel, 500
Canal Street, New Orleans, Louisiana 70130,
Telephone: (504) 525–2500, Fax: (504) 595–
5252.
Status: The meeting will be open to the
public.
Purpose: The purpose of the meeting is to
discuss services and issues related to the
health of migrant and seasonal farmworkers
and their families and to formulate
recommendations for the Secretary of Health
and Human Services.
Agenda: The agenda includes an overview
of the Council’s general business activities.
The Council will also hear presentations
from experts on farmworker issues, including
the status of farmworker health at the local
and national levels.
In addition, the Council will be holding a
public hearing at which migrant
farmworkers, community leaders, and
providers will have the opportunity to testify
before the Council regarding matters that
affect the health of migrant farmworkers. The
17:52 Oct 01, 2008
Jkt 217001
For Further Information Contact: Gladys
Cate, Office of Minority and Special
Populations, Bureau of Primary Health Care,
Health Resources and Services
Administration, 5600 Fishers Lane, Maryland
20857; telephone (301) 594–0367.
Dated: September 26, 2008.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E8–23228 Filed 10–1–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Aug<31>2005
hearing is scheduled for Wednesday,
November 19 from 9 a.m. to 12 p.m., at the
Sheraton New Orleans Hotel.
The Council meeting is being held in
conjunction with the Midwest Stream
Farmworker Health Forum sponsored by the
National Center for Farmworker Health,
which is being held in New Orleans,
Louisiana, November 19–22, 2008.
Agenda items are subject to change as
priorities indicate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Approval;
Comment Request; Extension of
Approved Collection; Responsibility of
Applicants for Promoting Objectivity in
Research for Which Public Health
Service Funding Is Sought, 42 CFR
Part 50, Subpart F and for Responsible
Prospective Contractors, 45 CFR Part
94 C
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on July 14, 2008 (Vol. 73, No.
135, p. 40354–40355) and allowed 60days for public comment. There were no
public comments received during this
time. The purpose of this notice is to
allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
PO 00000
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Fmt 4703
Sfmt 4703
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection
Title: Responsibility of Applicants for
Promoting Objectivity in Research for
which Public Health Service Funding is
Sought and for Responsible Prospective
Contractors, 42 CFR Part 50, Subpart F,
and 45 CFR Part 94.
Type of Information Collection
Request: Extension of OMB No. 0925–
0417, expiration date November 30,
2008.
Need and Use of the Information
Collection: This is a request for OMB
Approval for the information collection
and recordkeeping requirements
contained in the final rule 42 CFR Part
50, Subpart F and related recordkeeping
requirements regarding contractors in
Responsible Prospective Contractors, 45
CFR Part 94. The purpose of these
regulations is to promote objectivity in
research by requiring institutions to
establish standards to ensure that there
is no reasonable expectation that the
design, conduct, or reporting of research
will be biased by a conflicting financial
interest of an investigator.
Frequency of Response: On occasion.
Affected Public: Individuals or
households; business or other for-profit;
not-for-profit institutions; State, Local or
tribal government.
Type of Respondents: Any public or
private entity or organization.
The annual reporting burden is as
follows:
Estimated Number of Respondents:
67,860.
Estimated Number of Responses Per
Respondent: 1.60;
Averaged Burden Hours Per
Response: 3.40.; and
Estimated Total Annual Burden
Hours Requested: 220,280.
The annualized cost to the public is
estimated at $8,120,000.
Operating Costs and/or maintenance
costs are $4,633.00.
E:\FR\FM\02OCN1.SGM
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57366
Federal Register / Vol. 73, No. 192 / Thursday, October 2, 2008 / Notices
TABLE—ESTIMATES OF HOUR BURDEN
Type of respondents based on applicable section of
regulation
Number of
respondents
Frequency of
response
Average burden hours per
response
Annual hour
burden
Reporting
i 300
1
80 Hours ................................
24000
ii 40
1
2 Hours ..................................
80
iii 20
1
10 Hours ................................
200
1
4 Hours ..................................
100000
vi 40000
1
1
20 Hours ................................
1 Hour ....................................
56000
40000
68160
........................
................................................
220280
Initial Reports under 42 CFR § 50.604 (g)(2) or 45 CFR
94.4(g) (2) from Institutions.
Subsequent Reports under 42 CFR § 50.604 (g)(2) or 45
CFR 94.4(g)(2) from Institutions.
Subsequent Reports under 42 CFR § 50.606 (a) or 45 CFR
94.6 from Institutions.
Record Keeping
Under 42 CFR § 50.604 (e) or 45 CFR 94.4 (e)—Institutional
files.
iv 25000
Disclosure
Under 42 CFR § 50.604(a) or 45 CFR 94.4 (a)—Institutions
Under 42 CFR § 50.604(c) or 45 CFR 94.4 (c)—Investigators.
Totals ................................................................................
v 2800
i Although not more than 300 reports of Conflict of Interest are expected, the responding institutions must review all financial disclosures associated with PHS funded awards to determine whether any conflicts of interest exist. Thus, the total burden of 24,000 hours is based upon estimates that it will take on the average 4/5 of an hour to review each of 30,000 financial disclosures associated with PHS funding awards. (30,000
x 48 (minutes per file) =1,440,000 ÷ 60 minutes = 24,000 (total hours).
ii The burden for subsequent reports of conflicts (made during the 12 month period following the initial report) is significantly less, because we
do not expect may additional reportable conflicts and there will be only a limited number of disclosures to review.
iii This burden was originally estimated in the 1995 Final Rule to be no more than 5 instances that the failure of an investigator to comply with
the institution’s conflict of interest policy has biased the design, conduct or reporting of the research. ‘‘Objectivity in Research, Final Rule’’ 60 FR
132 (July 11, 1995) pps. 35810–35819. This burden estimate and others was increased in 2002 ‘‘due to increased numbers of institutions and investigators.’’
iv Assumes 2500 Institutions, 10 responses per year per institution.
v Assumes 2800 recipient Institutions and 20 hours per institution informing each investigator of institutional policy.
vi The financial disclosure burden estimate is based upon an investigator figure of 40,000 with an average response time of 1 hour. The estimated number of investigators has not changed since the 2002 Information Collection Request associated with the Final Rule. These estimates
are for the burden imposed by disclosure, reporting and recordkeeping requirements. Not all activities of institutions related to conflict of interest
result from regulations.
mstockstill on PROD1PC66 with NOTICES
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Attention: NIH Desk Officer, Office of
VerDate Aug<31>2005
17:52 Oct 01, 2008
Jkt 217001
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans contact: Ms. Mikia Currie,
Assistant Project Clearance Officer,
Office of Extramural Research, (OER),
Office of Policy for Extramural Research
Administration, (OPERA), 6705
Rockledge Drive, Room 1198, Bethesda,
MD 20892–7974, or call non-toll-free
number 301–435–0941 or E-mail your
request, including your address, to:
curriem@od.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: September 25, 2008.
Joe Ellis,
Director, Office of Policy of Extramural
Research Administration, National Institutes
of Health.
[FR Doc. E8–23171 Filed 10–1–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel. IBD,
Vaccinia Epitopes and NASH.
Date: October 14, 2008.
Time: 9 a.m. to 12 p.m.
E:\FR\FM\02OCN1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 192 (Thursday, October 2, 2008)]
[Notices]
[Pages 57365-57366]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23171]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Approval; Comment Request; Extension of
Approved Collection; Responsibility of Applicants for Promoting
Objectivity in Research for Which Public Health Service Funding Is
Sought, 42 CFR Part 50, Subpart F and for Responsible Prospective
Contractors, 45 CFR Part 94 C
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request to
review and approve the information collection listed below. This
proposed information collection was previously published in the Federal
Register on July 14, 2008 (Vol. 73, No. 135, p. 40354-40355) and
allowed 60-days for public comment. There were no public comments
received during this time. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection
Title: Responsibility of Applicants for Promoting Objectivity in
Research for which Public Health Service Funding is Sought and for
Responsible Prospective Contractors, 42 CFR Part 50, Subpart F, and 45
CFR Part 94.
Type of Information Collection Request: Extension of OMB No. 0925-
0417, expiration date November 30, 2008.
Need and Use of the Information Collection: This is a request for
OMB Approval for the information collection and recordkeeping
requirements contained in the final rule 42 CFR Part 50, Subpart F and
related recordkeeping requirements regarding contractors in Responsible
Prospective Contractors, 45 CFR Part 94. The purpose of these
regulations is to promote objectivity in research by requiring
institutions to establish standards to ensure that there is no
reasonable expectation that the design, conduct, or reporting of
research will be biased by a conflicting financial interest of an
investigator.
Frequency of Response: On occasion.
Affected Public: Individuals or households; business or other for-
profit; not-for-profit institutions; State, Local or tribal government.
Type of Respondents: Any public or private entity or organization.
The annual reporting burden is as follows:
Estimated Number of Respondents: 67,860.
Estimated Number of Responses Per Respondent: 1.60;
Averaged Burden Hours Per Response: 3.40.; and
Estimated Total Annual Burden Hours Requested: 220,280.
The annualized cost to the public is estimated at $8,120,000.
Operating Costs and/or maintenance costs are $4,633.00.
[[Page 57366]]
TABLE--Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
Type of respondents based on Number of Frequency of Average burden hours per Annual hour
applicable section of regulation respondents response response burden
----------------------------------------------------------------------------------------------------------------
Reporting
----------------------------------------------------------------------------------------------------------------
Initial Reports under 42 CFR Sec. \i\ 300 1 80 Hours................ 24000
50.604 (g)(2) or 45 CFR 94.4(g) (2)
from Institutions.
Subsequent Reports under 42 CFR Sec. \ii\ 40 1 2 Hours................. 80
50.604 (g)(2) or 45 CFR 94.4(g)(2)
from Institutions.
Subsequent Reports under 42 CFR Sec. \iii\ 20 1 10 Hours................ 200
50.606 (a) or 45 CFR 94.6 from
Institutions.
----------------------------------------------------------------------------------------------------------------
Record Keeping
----------------------------------------------------------------------------------------------------------------
Under 42 CFR Sec. 50.604 (e) or 45 \iv\ 25000 1 4 Hours................. 100000
CFR 94.4 (e)--Institutional files.
----------------------------------------------------------------------------------------------------------------
Disclosure
----------------------------------------------------------------------------------------------------------------
Under 42 CFR Sec. 50.604(a) or 45 \v\ 2800 1 20 Hours................ 56000
CFR 94.4 (a)--Institutions.
Under 42 CFR Sec. 50.604(c) or 45 \vi\ 40000 1 1 Hour.................. 40000
CFR 94.4 (c)--Investigators.
Totals............................ 68160 .............. ........................ 220280
----------------------------------------------------------------------------------------------------------------
\i\ Although not more than 300 reports of Conflict of Interest are expected, the responding institutions must
review all financial disclosures associated with PHS funded awards to determine whether any conflicts of
interest exist. Thus, the total burden of 24,000 hours is based upon estimates that it will take on the
average 4/5 of an hour to review each of 30,000 financial disclosures associated with PHS funding awards.
(30,000 x 48 (minutes per file) =1,440,000 / 60 minutes = 24,000 (total hours).
\ii\ The burden for subsequent reports of conflicts (made during the 12 month period following the initial
report) is significantly less, because we do not expect may additional reportable conflicts and there will be
only a limited number of disclosures to review.
\iii\ This burden was originally estimated in the 1995 Final Rule to be no more than 5 instances that the
failure of an investigator to comply with the institution's conflict of interest policy has biased the design,
conduct or reporting of the research. ``Objectivity in Research, Final Rule'' 60 FR 132 (July 11, 1995) pps.
35810-35819. This burden estimate and others was increased in 2002 ``due to increased numbers of institutions
and investigators.''
\iv\ Assumes 2500 Institutions, 10 responses per year per institution.
\v\ Assumes 2800 recipient Institutions and 20 hours per institution informing each investigator of
institutional policy.
\vi\ The financial disclosure burden estimate is based upon an investigator figure of 40,000 with an average
response time of 1 hour. The estimated number of investigators has not changed since the 2002 Information
Collection Request associated with the Final Rule. These estimates are for the burden imposed by disclosure,
reporting and recordkeeping requirements. Not all activities of institutions related to conflict of interest
result from regulations.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB
Written comments and/or suggestions regarding the item(s) contained
in this notice, especially regarding the estimated public burden and
associated response time, should be directed to the Attention: NIH Desk
Officer, Office of Management and Budget, at OIRA_
submission@omb.eop.gov or by fax to 202-395-6974. To request more
information on the proposed project or to obtain a copy of the data
collection plans contact: Ms. Mikia Currie, Assistant Project Clearance
Officer, Office of Extramural Research, (OER), Office of Policy for
Extramural Research Administration, (OPERA), 6705 Rockledge Drive, Room
1198, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-
0941 or E-mail your request, including your address, to:
curriem@od.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: September 25, 2008.
Joe Ellis,
Director, Office of Policy of Extramural Research Administration,
National Institutes of Health.
[FR Doc. E8-23171 Filed 10-1-08; 8:45 am]
BILLING CODE 4140-01-P
