Proposed Information Collection Activity; Comment Request, 3470-3471 [2010-963]
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3470
Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices
one or more other classes of employees in the
Special Exposure Cohort.
This designation became effective on
January 9, 2010, as provided for under
42 U.S.C. 7384l(14)(C). Hence,
beginning on January 9, 2010, members
of this class of employees, defined as
reported in this notice, became members
of the Special Exposure Cohort.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Interim Director,
Office of Compensation Analysis and
Support, National Institute for
Occupational Safety and Health
(NIOSH), 4676 Columbia Parkway, MS
C–46, Cincinnati, OH 45226, Telephone
513–533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2010–1088 Filed 1–20–10; 8:45 am]
BILLING CODE 4163–19–P
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY: The Department of Health and
Human Services (HHS) gives notice
concerning the final effect of the HHS
decision to designate a class of
employees at the Metals and Controls
Corp. in Attleboro, Massachusetts, as an
addition to the Special Exposure Cohort
(SEC) under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. On December 10,
2009, as provided for under 42 U.S.C.
7384q(b), the Secretary of HHS
designated the following class of
employees as an addition to the SEC:
All Atomic Weapons Employees who
worked at Metals and Controls Corp. in
Attleboro, MA, from January 1, 1952 to
December 31, 1967, for a number of work
days aggregating at least 250 work days,
occurring either solely under this
employment or in combination with work
days within the parameters established for
one or more other classes of employees
included in the SEC.
This designation became effective on
January 9, 2010, as provided for under
42 U.S.C. 7384l(14)(C). Hence,
16:17 Jan 20, 2010
Jkt 220001
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2010–1096 Filed 1–20–10; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Final Effect of Designation of a Class
of Employees for Addition to the
Special Exposure Cohort
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Nov<24>2008
beginning on January 9, 2010, members
of this class of employees, defined as
reported in this notice, became members
of the Special Exposure Cohort.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Interim Director,
Office of Compensation Analysis and
Support, National Institute for
Occupational Safety and Health
(NIOSH), 4676 Columbia Parkway, MS
C–46, Cincinnati, OH 45226, Telephone
513–533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
SUMMARY: The Department of Health and
Human Services (HHS) gives notice
concerning the final effect of the HHS
decision to designate a class of
employees at the Brookhaven National
Laboratory in Upton, New York, as an
addition to the Special Exposure Cohort
(SEC) under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. On December 10,
2009, as provided for under 42 U.S.C.
7384q(b), the Secretary of HHS
designated the following class of
employees as an addition to the SEC:
All employees of the Department of
Energy, its predecessor agencies, and its
contractors and subcontractors who worked
at the Brookhaven National Laboratory in
Upton, New York, from January 1,1947 to
December 31,1979, for a number of work
days aggregating at least 250 work days,
occurring either solely under this
employment, or in combination with work
days within the parameters established for
one or more other classes of employees in the
Special Exposure Cohort.
This designation became effective on
January 9, 2010, as provided for under
42 U.S.C. 7384l(14)(C). Hence,
beginning on January 9, 2010, members
of this class of employees, defined as
reported in this notice, became members
of the Special Exposure Cohort.
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FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Interim Director,
Office of Compensation Analysis and
Support, National Institute for
Occupational Safety and Health
(NIOSH), 4676 Columbia Parkway, MS
C–46, Cincinnati, OH 45226, Telephone
513–533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2010–1090 Filed 1–20–10; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Tribal Child Support
Enforcement Direct Funding Request: 45
CFR 309—Plan Form OCSE 34A;
Statistical Reporting.
OMB No.: 0970–0218.
Description: The final rule within 45
CFR part 309, published in the Federal
Register on March 30, 2004, contains a
regulatory reporting requirement that, in
order to receive funding for a Tribal IV–
D program a Tribe or Tribal organization
must submit a plan describing how the
Tribe or Tribal organization meets or
plans to meet the objectives of section
455(f) of the Social Security Act,
including establishing paternity,
establishing, modifying, and enforcing
support orders, and locating
noncustodial parents. The plan is
required for all Tribes requesting
funding; however, once a Tribe has met
the requirements to operate a
comprehensive program, a new plan is
not required annually unless a Tribe
makes changes to its title IV–D program.
Tribes and Tribal organizations must
respond if they wish to operate a fully
funded program. In addition, any Tribe
or Tribal organization participating in
the program will be required to submit
form OCSE 34A. This paperwork
collection activity is set to expire in
September, 2010.
Respondents: Tribes and Tribal
Organizations.
Annual Burden Estimates
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21JAN1
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Federal Register / Vol. 75, No. 13 / Thursday, January 21, 2010 / Notices
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
45 CFR 309—Plan ..........................................................................................
Form OCSE 34A ..............................................................................................
33
49
1
4
480
8
15,840
1,568
Estimated total burdenhours ....................................................................
........................
........................
........................
17,408
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: January 14, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–963 Filed 1–20–10; 8:45 am]
jlentini on DSKJ8SOYB1PROD with NOTICES
BILLING CODE 4184–01–P
VerDate Nov<24>2008
16:17 Jan 20, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0470]
International Conference on
Harmonisation; Guidance on M3(R2)
Nonclinical Safety Studies for the
Conduct of Human Clinical Trials and
Marketing Authorization for
Pharmaceuticals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘M3(R2) Nonclinical Safety Studies for
the Conduct of Human Clinical Trials
and Marketing Authorization for
Pharmaceuticals.’’ The guidance was
prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance, which is a revision of an
existing guidance, discusses the types of
nonclinical studies, their scope and
duration, and their relation to the
conduct of human clinical trials and
marketing authorization for
pharmaceuticals. The guidance is
intended to facilitate the timely conduct
of clinical trials and reduce the
unnecessary use of animals and other
drug development resources.
DATES: Submit written or electronic
comments on agency guidance at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, 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, Rockville, MD
20852–1448. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. Send
two self-addressed adhesive labels to
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assist the office in processing your
requests.
Submit electronic comments to https://
www.regulations.gov. 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. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Abigail
Jacobs, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New
Hampshire Ave, Bldg. 22, rm. 6484,
Silver Spring, MD 20993–0002,
301–796–0174; or Martin D. Green,
Center for Biologics Evaluation and
Research (HFM–475), Food and
Drug Administration, 1401
Rockville Pike, suite 200N,
Rockville, MD 20852–1448, 301–
827–3070.
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
harmonization of technical
requirements for the registration of
pharmaceutical products among three
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Agencies
[Federal Register Volume 75, Number 13 (Thursday, January 21, 2010)]
[Notices]
[Pages 3470-3471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-963]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Tribal Child Support Enforcement Direct Funding Request: 45
CFR 309--Plan Form OCSE 34A; Statistical Reporting.
OMB No.: 0970-0218.
Description: The final rule within 45 CFR part 309, published in
the Federal Register on March 30, 2004, contains a regulatory reporting
requirement that, in order to receive funding for a Tribal IV-D program
a Tribe or Tribal organization must submit a plan describing how the
Tribe or Tribal organization meets or plans to meet the objectives of
section 455(f) of the Social Security Act, including establishing
paternity, establishing, modifying, and enforcing support orders, and
locating noncustodial parents. The plan is required for all Tribes
requesting funding; however, once a Tribe has met the requirements to
operate a comprehensive program, a new plan is not required annually
unless a Tribe makes changes to its title IV-D program. Tribes and
Tribal organizations must respond if they wish to operate a fully
funded program. In addition, any Tribe or Tribal organization
participating in the program will be required to submit form OCSE 34A.
This paperwork collection activity is set to expire in September, 2010.
Respondents: Tribes and Tribal Organizations.
Annual Burden Estimates
[[Page 3471]]
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
45 CFR 309--Plan................................ 33 1 480 15,840
Form OCSE 34A................................... 49 4 8 1,568
---------------------------------------------------------------
Estimated total burdenhours................. .............. .............. .............. 17,408
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) 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.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: January 14, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-963 Filed 1-20-10; 8:45 am]
BILLING CODE 4184-01-P