Proposed Collection; Comment Request; NIH Office of Intramural Training and Education Application, 42097-42098 [2010-17669]
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42097
Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
Respondents
21 CFR Section
111.75(a)(1)(ii)
1 There
Annual Frequency
per Response
1
Total Annual
Responses
1
Hours per
Response
1
Total Hours
8
8
are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, FDA has not
received any new petitions to request an
exemption from 100 percent identity
testing of dietary ingredients; therefore,
the agency estimates that one or fewer
petitions will be submitted annually.
Although FDA has not received any new
petitions to request an exemption from
100 percent identity testing of dietary
ingredients in the last 3 years, it
believes that these information
collection provisions should be
extended to provide for the potential
future need of a firm in the dietary
supplement industry to petition for an
exemption from 100 percent identity
testing of dietary ingredients. Based on
our experience with petition processes,
we estimate that the assembly of
information in support of the petition
required by § 111.75(a)(1)(ii) will take 8
hours.
Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–17608 Filed 7–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NIH Office of Intramural
Training and Education Application
Summary
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, for
opportunity for public comment on
proposed data collection projects, the
Office of Intramural Training &
Education/OIR/OD, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: NIH Office of Intramural
Training & Education Application. Type
of Information Collection Request:
Revision. Form Number: 0925–0299.
Expiration Date: September 30, 2012.
Need and Use of Information Collection:
The Office of Intramural Training &
Education (OITE) administers a variety
of programs and initiatives to recruit
pre-college through post-doctoral
educational level individuals into the
National Institutes of Health Intramural
Research Program (NIH–IRP) to facilitate
develop into future biomedical
scientists. The proposed information
collection is necessary in order to
determine the eligibility and quality of
potential awardees for traineeships in
these programs. The applications for
admission consideration include key
areas such as: Personal information,
eligibility criteria, contact information,
student identification number, training
program selection, scientific discipline
interests, educational history,
standardized examination scores,
reference information, resume
components, employment history,
employment interests, dissertation
research details, letters of
recommendation, financial aid history,
sensitive data, future networking
contact, travel information, as well as
feedback questions about interviews and
application submission experiences.
Sensitive data collected on the
applicants, race, gender, ethnicity and
recruitment method, are made available
only to OITE staff members or in
aggregate form to select NIH offices and
are not used by the admission
committee for admission consideration;
optional to submit.
Over the last several years the OITE
has used three OMB Clearance Numbers
for the collection of applications for the
training programs. To improve
announcement of all training programs
and lessen the burden of applicants, the
OITE proposes to merge the following:
• 0925–0299—NIH Intramural
Research Training Award, Program
Application.
• 0925–0438—Undergraduate
Scholarship Program (UGSP).
• 0925–0501—Graduate Student
Training Program Application.
Renewing 0925–0299 OMB Clearance
Number with the new name ‘‘Office of
Intramural Training & Education
Application’’.
Frequency of Response: On occasion.
Affected Public: Individuals seeking
intramural training opportunities and
references for these individuals. Type of
Respondents: students, postbaccalaureates, technicians, graduate
students, and post-doctorates. There are
no capital costs, operating costs, and/or
maintenance costs to report.
The annual reporting burden is
displayed in the following table:
ESTIMATES OF HOUR BURDEN
Estimated
number of respondents
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Program
Estimated
number of responses annually per respondent
Average burden hours per
response
Estimated total
annual burden
hours
8,500
100
2,300
550
125
140
600
2,050
825
300
1,900
1
1
1
1
1
1
1
1
1
1
1
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
0.75
6,375.0
75.0
1,725.0
412.5
93.8
105.0
450.0
1,537.5
618.8
225.0
1,425.0
Summer Internship Program in Biomedical Research (SIP) ...........................
Biomedical Engineering Summer Internship Program (BESIP) ......................
Post-baccalaureate Intramural Research Training Award ...............................
NIH Academy ...................................................................................................
Community College Summer Enrichment Program (CCSEP) ........................
Technical Intramural Research Training Award ..............................................
Graduate Partnerships Program (GPP) ...........................................................
Post-Doctorate Fellowship Program ................................................................
National Graduate Student Research Festival (NGSRF) ................................
Undergraduate Scholarship Program (UGSP) ................................................
Alumni Database .............................................................................................
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42098
Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices
ESTIMATES OF HOUR BURDEN—Continued
Estimated
number of respondents
Estimated
number of responses annually per respondent
Average burden hours per
response
Estimated total
annual burden
hours
Recommendations for All Programs ................................................................
Supplemental Documents for Application ........................................................
Feedback Questions ........................................................................................
35,705
14,540
53,095
1
1
1
0.25
0.75
0.25
8,926.3
10,905.0
13,273.8
Totals ........................................................................................................
120,730
Program
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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Dr. Patricia
Wagner, Director of Admissions &
Registrar, Office of Intramural Training
& Education, National Institutes of
Health, 2 Center Drive, Building 2/Room
2E06, Bethesda, Maryland 20892–0234,
or call 240–476–3619 or e-mail your
request, including your address to:
wagnerpa@od.nih.gov.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
DATES: Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Date: July 15, 2010.
Michael M. Gottesman,
Deputy Director for Intramural Research,
National Institutes of Health.
[FR Doc. 2010–17669 Filed 7–19–10; 8:45 am]
BILLING CODE 4140–01–P
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15:23 Jul 19, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0327]
International Conference on
Harmonisation; Draft Recommendation
for the Revision of the Permitted Daily
Exposure for the Solvent Cumene
According to the Maintenance
Procedures for the Guidance Q3C
Impurities: Residual Solvents;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft recommendation
for the revision of the permitted daily
exposure (PDE) for the solvent cumene
according to the maintenance
procedures for the guidance for industry
entitled ‘‘Q3C: Impurities: Residual
Solvents.’’ The draft recommendation
was prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
recommendation before it begins work
on the final recommendation, submit
either electronic or written comments
on the document by September 20,
2010.
ADDRESSES: Submit written requests for
single copies of the draft
recommendation to the Division of Drug
Information (HFD–240), Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
46,147.5
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft recommendation may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
recommendation.
Submit electronic comments on the
draft recommendation to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: David
Jacobson-Kram, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–0175.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
E:\FR\FM\20JYN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42097-42098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17669]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; NIH Office of Intramural
Training and Education Application
Summary
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, for opportunity for public comment on
proposed data collection projects, the Office of Intramural Training &
Education/OIR/OD, the National Institutes of Health (NIH) will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
Proposed Collection
Title: NIH Office of Intramural Training & Education Application.
Type of Information Collection Request: Revision. Form Number: 0925-
0299. Expiration Date: September 30, 2012. Need and Use of Information
Collection: The Office of Intramural Training & Education (OITE)
administers a variety of programs and initiatives to recruit pre-
college through post-doctoral educational level individuals into the
National Institutes of Health Intramural Research Program (NIH-IRP) to
facilitate develop into future biomedical scientists. The proposed
information collection is necessary in order to determine the
eligibility and quality of potential awardees for traineeships in these
programs. The applications for admission consideration include key
areas such as: Personal information, eligibility criteria, contact
information, student identification number, training program selection,
scientific discipline interests, educational history, standardized
examination scores, reference information, resume components,
employment history, employment interests, dissertation research
details, letters of recommendation, financial aid history, sensitive
data, future networking contact, travel information, as well as
feedback questions about interviews and application submission
experiences. Sensitive data collected on the applicants, race, gender,
ethnicity and recruitment method, are made available only to OITE staff
members or in aggregate form to select NIH offices and are not used by
the admission committee for admission consideration; optional to
submit.
Over the last several years the OITE has used three OMB Clearance
Numbers for the collection of applications for the training programs.
To improve announcement of all training programs and lessen the burden
of applicants, the OITE proposes to merge the following:
0925-0299--NIH Intramural Research Training Award, Program
Application.
0925-0438--Undergraduate Scholarship Program (UGSP).
0925-0501--Graduate Student Training Program Application.
Renewing 0925-0299 OMB Clearance Number with the new name ``Office
of Intramural Training & Education Application''.
Frequency of Response: On occasion. Affected Public: Individuals
seeking intramural training opportunities and references for these
individuals. Type of Respondents: students, post-baccalaureates,
technicians, graduate students, and post-doctorates. There are no
capital costs, operating costs, and/or maintenance costs to report.
The annual reporting burden is displayed in the following table:
Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated
Program number of responses hours per total annual
respondents annually per response burden hours
respondent
----------------------------------------------------------------------------------------------------------------
Summer Internship Program in Biomedical Research 8,500 1 0.75 6,375.0
(SIP)..........................................
Biomedical Engineering Summer Internship Program 100 1 0.75 75.0
(BESIP)........................................
Post-baccalaureate Intramural Research Training 2,300 1 0.75 1,725.0
Award..........................................
NIH Academy..................................... 550 1 0.75 412.5
Community College Summer Enrichment Program 125 1 0.75 93.8
(CCSEP)........................................
Technical Intramural Research Training Award.... 140 1 0.75 105.0
Graduate Partnerships Program (GPP)............. 600 1 0.75 450.0
Post-Doctorate Fellowship Program............... 2,050 1 0.75 1,537.5
National Graduate Student Research Festival 825 1 0.75 618.8
(NGSRF)........................................
Undergraduate Scholarship Program (UGSP)........ 300 1 0.75 225.0
Alumni Database................................. 1,900 1 0.75 1,425.0
[[Page 42098]]
Recommendations for All Programs................ 35,705 1 0.25 8,926.3
Supplemental Documents for Application.......... 14,540 1 0.75 10,905.0
Feedback Questions.............................. 53,095 1 0.25 13,273.8
������������������������������������������������������������������
----------------------------------------------------------------------------------------------------------------
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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Dr. Patricia Wagner, Director of Admissions &
Registrar, Office of Intramural Training & Education, National
Institutes of Health, 2 Center Drive, Building 2/Room 2E06, Bethesda,
Maryland 20892-0234, or call 240-476-3619 or e-mail your request,
including your address to: wagnerpa@od.nih.gov.
DATES: Comments Due Date: Comments regarding this information
collection are best assured of having their full effect if received
within 60 days of the date of this publication.
Date: July 15, 2010.
Michael M. Gottesman,
Deputy Director for Intramural Research, National Institutes of Health.
[FR Doc. 2010-17669 Filed 7-19-10; 8:45 am]
BILLING CODE 4140-01-P
