Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service (IHS) Background Investigations of Individuals in Position Involving Regular Contact With or Control Over Indian Children OPM-306., 51826-51827 [05-17320]
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51826
Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices
301–827–9035, FAX: 301–827–8907,
henriksone@cder.fda.gov or Qiang
Zheng, Peking University, Beijing,
China, 86–10–6275–6489, FAX: 86–10–
6275–1207, zhengqiang@pku.edu.cn.
SUPPLEMENTARY INFORMATION:
https://www.fda.gov/cder/meeting/
CTP2005.htm.
I. General Information
FDA is cosponsoring these 3-day
workshops to provide information and
training opportunities for industry as
well as CGMP compliance officials.
A. Who Should Attend?
This announcement is directed
towards professionals involved in the
manufacture, control, and regulation of
pharmaceutical products who will
benefit from these workshops, including
process/production engineers,
manufacturing personnel, quality
assurance/quality control and regulatory
affairs professionals, consultants,
regulatory investigators and CGMP
compliance officials. Other entities or
individuals may also be interested in
attending.
B. Where and When Will These
Workshops Be Held?
The location and times for the two
workshops are listed in table 1 of this
document.
B. What Will Be Covered?
The workshops will provide
information on specific topics designed
to educate and guide participants on
methodologies and implementation of
CGMP as applied to quality drug
manufacturing. Presentations by both
FDA and industry will provide a
regulatory and practical perspective on
the current relevant critical topics.
Dated: August 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17248 Filed 8–30–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Workshop Address
Dates and Local
Times
Ying Jie Convention
Center, Peking University, Beijing,
China
Ying Jie Convention
Center, Peking University, Beijing,
China
December 5 through
7, 2005, from 9
a.m. to 5 p.m. each
day.
April 24 through 26,
2006, from 9 a.m.
to 5 p.m. each day.
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service (IHS)
Background Investigations of
Individuals in Position Involving
Regular Contact With or Control Over
Indian Children OPM–306.
Indian Health Service, HHS.
The Department of Health and
Human Services, as part of its
continuing efforts to reduce paperwork
and respondent burden, conducts a preclearance consultation program to
provide the general public and Federal
agencies with an opportunity to
comment on proposed and/or
continuing collections of information in
accordance with the Paperwork
Reduction Act of 1995 (PRA95) (44
U.S.C. 3506(c)(2)(A)). This program
helps to ensure that requested data can
be provided in the desired format,
reporting burden (time and financial
resources) is minimized, collection
instruments are clearly understood, and
the impact of collection requirements on
respondents can be properly assessed.
Currently, the IHS is providing a 60-day
advance opportunity for public
comment on a proposed extension of
current information collection activity
to be submitted to the office of
Management and Budget for review.
AGENCY:
C. How Can I Participate?
You can participate in person.
Anyone interested in the GMP
workshops can register through the
contact person in the FOR FURTHER
INFORMATION CONTACT section of this
document.
SUMMARY:
D. Is There a Registration Fee for These
Workshops?
Yes, a registration fee of $440 is
required for this workshop. This
registration fee includes workshop
reference materials and meals.
Government employees qualify for a
discounted rate of $120.
E. How Can I Get Additional
Information?
The notice of participation form,
information about the workshops, and
other related documents are available
from the contact person in the FOR
FURTHER INFORMATION CONTACT section of
this document or from the Internet at
16:33 Aug 30, 2005
A. Why Is FDA Cosponsoring These
Workshops?
BILLING CODE 4160–01–S
TABLE 1.—WORKSHOP LOCATION AND
SCHEDULES
VerDate Aug<18>2005
II. Background Information
Jkt 205001
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
Proposed Collection
Title: 0917–0028, ‘‘IHS Background
Investigations of Individuals in
Positions Involving Regular Contact
With or Control Over Indian Children’’
OPM–306.
Type of Information Collection
Request: Extension, without revision, of
currently approved information
collection, 0917–0028. ‘‘IHS
Background Investigations of
Individuals in Position Involving
Regular Contact With or Control Over
Indian Children’’ OPM–306.
Form Number: OF–306.
Forms: Declaration for Federal
Employment.
Need and Use of Information
Collection: This is a request for approval
of collection information required by
section 408 of the Indian Child
Protection and Family Violence
Prevention Act, Public Law 101–630,
104 Stat. 4544, 25 U.S.C. 3201–3211.
The IHS is required to compile a list of
all authorized positions within the IHS
where the duties and responsibilities
involve regular contact with, or control
over, Indian children; and to conduct an
investigation of the character of each
individual who is employed, or is being
considered for employment in a
position having regular contact with, or
control over, Indian children. Section
3207(b) of the Indian Child Protection
and Family Violence Prevention Act
was amended by section 814 of S. 3031,
the Native American Laws Technical
Corrections Act of 2000, which requires
that the regulations prescribing the
minimum standards of character ensure
that none of the individuals appointed
to positions involving regular contact
with, or control over Indian children
have been found guilty of, or entered a
plea of nolo contendere or guilty to any
felonious offense, or any of two or more
misdemeanor offenses under Federal,
State, or tribal law involving crimes of
violence; sexual assault, molestation,
exploitation, contact or prostitution;
crimes against persons; or offenses
committed against children. In addition,
42 U.S.C. 13041 requires each agency of
the Federal Government, and every
facility operated by the Federal
Government (or operated under contract
with the Federal Government), that
hires (or contracts for hire) individuals
involved with children under the age of
18 or child care services to assure that
all existing and newly-hired employees
undergo a criminal history background
check. The background is to be initiated
through the personnel program of the
applicable Federal agency. This section
requires employment applications for
individuals who are seeking work for an
E:\FR\FM\31AUN1.SGM
31AUN1
51827
Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Notices
agency of the Federal Government, or
for a facility or program operated by (or
through contract with) the Federal
Government, in positions involved with
the provision to children under the age
of 18 or child care services, to contain
a question asking whether the
individual has ever been arrested for or
charged with a crime involving a child.
Affected Public: Individuals and
households.
Type of Respondents: Individuals.
The table below provides the
estimated burden hours for this
information collection:
ESTIMATED BURDEN HOURS
42 CFR Part 36
Estimated
number of
respondents
Responses
per
respondent
Average burden hour per
response *
Total annual
burden hours
Addendum to OF 306 Declaration for Federal Employment ...........................
2,000
1
0.25 (15 mins)
500
* For ease of understanding, burden hours are also provided in actual minutes.
There are no Capital Costs, Operating
Costs and/or Maintenance Costs to
report.
Request For Comments: Your written
comments and/or suggestions are
invited on one or more of the following
points: (a) Whether the information
collection activity is necessary to carry
out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of public burden
estimate (the estimated amount of time
needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimate are logical; (e) ways to enhance
the quality, utility, and clarity of the
information being collected; and (f)
ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Send Comments and Requests For
Further Information: Send your written
comments and requests for more
information on the proposed collection
or requests to obtain a copy of the data
collection instrument(s) and
instructions to: Mrs. Chris Rouleau, IHS
Reports Clearance Officer, 801
Thompson Avenue, Rockville, MD
20852, call non-toll free (301) 443–5938,
send via facsimile to (301) 443–2316, or
send your E-mail requests, comments,
and return address to:
crouleau@hqe.ihs.gov.
Comment Due Date: Your comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
VerDate Aug<18>2005
16:33 Aug 30, 2005
Jkt 205001
Dated: August 24, 2005.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. 05–17320 Filed 8–30–05; 8:45 am]
BILLING CODE 4165–16–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Survey of NIGMS
Minority Opportunities in Research
(MORE) Division Institutional Program
Directors
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of General Medical Sciences
(NIGMS), the National Institutes of
Health (NIH) has submitted to the Office
of Management and Budget (OMB) a
request for review and approval of the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on February 22, 2005, pages
8594–8595 and allowed 60 days for
public comment. No public comments
were received. 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: Survey of
NIGMS Minority Opportunities in
Research (MORE) Division Institutional
Program Directors. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: NIGMS
provides research and research training
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
support in the basic biomedical sciences
through a variety of programs and grant
mechanisms. Several of these programs
are targeted toward support of
underrepresented minority students at
various educational levels and research
faculty at minority-serving institutions.
Although significant resources are
dedicated to funding these programs,
there is a lack of quantitative
information on program outcomes. This
proposed one-time survey is part of a
larger study that will provide NIGMS
with the high-quality data needed to
evaluate the educational outcomes and
research activity of students and faculty
who are supported by NIGMS training
and research support programs. Data on
student enrollment and highest degree
received will be collected from
institutional program directors in the
following programs: Minority Access to
Research Careers Undergraduate
Student Training in Academic Research
(U*STAR), Minority Biomedical
Research Support Initiative for Minority
Student Development (IMSD), and
Minority Biomedical Research Support
Research Initiative for Scientific
Enhancement (RISE). Other data will be
collected from existing sources,
including grant records and Medline
databases. Taken together, the data will
be used as a baseline for future
assessments, as well to further develop
current programs and in the creation of
proposals for new initiatives in minority
recruitment and training. These results
will be reported to the National
Advisory General Medical Sciences
Council (NAGMSC) and shared with the
community of NIGMS grantees.
Frequency of Response: Once. Affected
Public: Individuals or households; Notfor-profits. Type of Respondents:
Training grant program directors.
The annual reporting burden is as
follows:
E:\FR\FM\31AUN1.SGM
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Agencies
[Federal Register Volume 70, Number 168 (Wednesday, August 31, 2005)]
[Notices]
[Pages 51826-51827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17320]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day Proposed Information
Collection: Indian Health Service (IHS) Background Investigations of
Individuals in Position Involving Regular Contact With or Control Over
Indian Children OPM-306.
AGENCY: Indian Health Service, HHS.
SUMMARY: The Department of Health and Human Services, as part of its
continuing efforts to reduce paperwork and respondent burden, conducts
a pre-clearance consultation program to provide the general public and
Federal agencies with an opportunity to comment on proposed and/or
continuing collections of information in accordance with the Paperwork
Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program
helps to ensure that requested data can be provided in the desired
format, reporting burden (time and financial resources) is minimized,
collection instruments are clearly understood, and the impact of
collection requirements on respondents can be properly assessed.
Currently, the IHS is providing a 60-day advance opportunity for public
comment on a proposed extension of current information collection
activity to be submitted to the office of Management and Budget for
review.
Proposed Collection
Title: 0917-0028, ``IHS Background Investigations of Individuals in
Positions Involving Regular Contact With or Control Over Indian
Children'' OPM-306.
Type of Information Collection Request: Extension, without
revision, of currently approved information collection, 0917-0028.
``IHS Background Investigations of Individuals in Position Involving
Regular Contact With or Control Over Indian Children'' OPM-306.
Form Number: OF-306.
Forms: Declaration for Federal Employment.
Need and Use of Information Collection: This is a request for
approval of collection information required by section 408 of the
Indian Child Protection and Family Violence Prevention Act, Public Law
101-630, 104 Stat. 4544, 25 U.S.C. 3201-3211. The IHS is required to
compile a list of all authorized positions within the IHS where the
duties and responsibilities involve regular contact with, or control
over, Indian children; and to conduct an investigation of the character
of each individual who is employed, or is being considered for
employment in a position having regular contact with, or control over,
Indian children. Section 3207(b) of the Indian Child Protection and
Family Violence Prevention Act was amended by section 814 of S. 3031,
the Native American Laws Technical Corrections Act of 2000, which
requires that the regulations prescribing the minimum standards of
character ensure that none of the individuals appointed to positions
involving regular contact with, or control over Indian children have
been found guilty of, or entered a plea of nolo contendere or guilty to
any felonious offense, or any of two or more misdemeanor offenses under
Federal, State, or tribal law involving crimes of violence; sexual
assault, molestation, exploitation, contact or prostitution; crimes
against persons; or offenses committed against children. In addition,
42 U.S.C. 13041 requires each agency of the Federal Government, and
every facility operated by the Federal Government (or operated under
contract with the Federal Government), that hires (or contracts for
hire) individuals involved with children under the age of 18 or child
care services to assure that all existing and newly-hired employees
undergo a criminal history background check. The background is to be
initiated through the personnel program of the applicable Federal
agency. This section requires employment applications for individuals
who are seeking work for an
[[Page 51827]]
agency of the Federal Government, or for a facility or program operated
by (or through contract with) the Federal Government, in positions
involved with the provision to children under the age of 18 or child
care services, to contain a question asking whether the individual has
ever been arrested for or charged with a crime involving a child.
Affected Public: Individuals and households.
Type of Respondents: Individuals.
The table below provides the estimated burden hours for this
information collection:
Estimated Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Average burden
42 CFR Part 36 number of Responses per hour per Total annual
respondents respondent response * burden hours
----------------------------------------------------------------------------------------------------------------
Addendum to OF 306 Declaration for Federal 2,000 1 0.25 (15 mins) 500
Employment.................................
----------------------------------------------------------------------------------------------------------------
* For ease of understanding, burden hours are also provided in actual minutes.
There are no Capital Costs, Operating Costs and/or Maintenance
Costs to report.
Request For Comments: Your written comments and/or suggestions are
invited on one or more of the following points: (a) Whether the
information collection activity is necessary to carry out an agency
function; (b) whether the agency processes the information collected in
a useful and timely fashion; (c) the accuracy of public burden estimate
(the estimated amount of time needed for individual respondents to
provide the requested information); (d) whether the methodology and
assumptions used to determine the estimate are logical; (e) ways to
enhance the quality, utility, and clarity of the information being
collected; and (f) ways to minimize the public burden through the use
of automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology.
Send Comments and Requests For Further Information: Send your
written comments and requests for more information on the proposed
collection or requests to obtain a copy of the data collection
instrument(s) and instructions to: Mrs. Chris Rouleau, IHS Reports
Clearance Officer, 801 Thompson Avenue, Rockville, MD 20852, call non-
toll free (301) 443-5938, send via facsimile to (301) 443-2316, or send
your E-mail requests, comments, and return address to:
crouleau@hqe.ihs.gov.
Comment Due Date: Your comments regarding this information
collection are best assured of having their full effect if received
within 60-days of the date of this publication.
Dated: August 24, 2005.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. 05-17320 Filed 8-30-05; 8:45 am]
BILLING CODE 4165-16-M