National Institute of Environmental Health Sciences, Division of Extramural Research and Training; Proposed Collection; Comment Request Hazardous Waste Worker Training, 17195-17196 [E9-8472]
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Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
ACTION: Notice of Non-competitive
Replacement Award.
SUMMARY: The Health Resources and
Services Administration (HRSA) is
issuing a temporary non-competitive
replacement award to the National
Jewish Hospital and Research Center to
avoid disruption and continue outreach,
medical screening and referral services
to former uranium mine workers and
individuals in the states of Colorado,
Wyoming and portions of Southeastern
Utah exposed to radioactive fallout
during prior testing of nuclear weapons.
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
National Jewish Hospital and Research
Center in Denver, Colorado.
Amount of the Award: $120,106.00
(an 8-month supplement, January 1,
2009, through August 31, 2009) to
ensure ongoing services to the target
populations.
Project Period: The period of
supplemental support is from January 1,
2009, to August 31, 2009.
Authority: This activity is under the
authority of the Public Health Service Act,
Section 417C of Public Law 106–245.
16:39 Apr 13, 2009
Jkt 217001
Dated: April 9, 2009.
Marcia K. Brand,
Deputy Administrator.
[FR Doc. E9–8442 Filed 4–13–09; 8:45 am]
BILLING CODE 4165–15–P
Catalogue of Federal Domestic
Assistance Number: 93.257
Justication for the Exception to
Competition: Critical funding for
outreach, medical screening and referral
services to the target populations in
Colorado, Wyoming and portions of
Southeastern Utah will be continued
through a temporary, non-competitive
replacement award to the National
Jewish Hospital and Research Center
(NJHRC) as the new recipient. This
temporary award is needed because the
former grantee, St. Mary’s Hospital and
Medical Center, relinquished, effective
December 31, 2008, the original award
(project period September 1, 2008,
through August 31, 2011). NJHRC,
nationally known as the ‘‘Center for
Research and Treatment of Respiratory
Conditions,’’ is uniquely qualified to
provide screening and diagnosis of
occupationally related radiogenic
diseases for the target populations.
NJHRC has administered the HRSAfunded Black Lung Clinic Program
(BLCP) grant for the past five years and
is well suited to undertake operations of
the Radiation Exposure Screening and
Education Program under the previously
approved scope of project. Additionally,
this organization has a thorough
understanding of the characteristics and
needs of miners (both current and
retired) as well as other workers at risk
for occupational diseases. HRSA’s
Office of Rural Health Policy is not
aware of any other organization that
VerDate Nov<24>2008
could provide such treatment and
services to the impacted service
populations without additional time
and resources being devoted to bringing
that organization’s service capacity up
to the level needed under the project
scope of this award.
This temporary non-competitive
replacement award will permit the new
recipient to ensure continuity of
services to the affected populations. The
supplemental funding will provide
support for 8 months. Further funding
beyond August 31, 2009, for this service
area will be provided through a limited
service area competition to be
announced in the near future.
FOR FURTHER INFORMATION CONTACT: Tom
Morris, Associate Administrator, Office
of Rural Health Policy, Health Resources
and Services Administration, 5600
Fishers Lane, Rockville, MD 20857;
phone 301–443–0835;
tmorris@hrsa.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences, Division of
Extramural Research and Training;
Proposed Collection; Comment
Request Hazardous Waste Worker
Training
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
National Institute of Environmental
Health Sciences (NIEHS), 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: Hazardous
Waste Worker Training—42 CFR part
65. Type of Information Collection
Request: Revision of OMB No. 0925–
0348 and expiration date September 30,
2009. Need and Use of Information
Collection: This request for OMB review
and approval of the information
collection is required by regulation 42
CFR part 65(a)(6). The National Institute
of Environmental Health Sciences
(NIEHS) was given major responsibility
for initiating a worker safety and health
training program under Section 126 of
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
17195
the Superfund Amendments and
Reauthorization Act of 1986 (SARA) for
hazardous waste workers and
emergency responders. A network of
non-profit organizations that are
committed to protecting workers and
their communities by delivering highquality, peer-reviewed safety and health
curricula to target populations of
hazardous waste workers and
emergency responders has been
developed. In twenty-one years (FY
1987–2008), the NIEHS Worker Training
program has successfully supported 20
primary grantees that have trained more
than 2.2 million workers across the
country and presented over 130,250
classroom and hands-on training
courses, which have accounted for
nearly 30 million contact hours of actual
training. Generally, the grant will
initially be for one year, and subsequent
continuation awards are also for one
year at a time. Grantees must submit a
separate application to have the support
continued for each subsequent year.
Grantees are to provide information in
accordance with S65.4(a), (b), (c) and
65.6(a) on the nature, duration, and
purpose of the training, selection
criteria for trainees’ qualifications and
competency of the project director and
staff, cooperative agreements in the case
of joint applications, the adequacy of
training plans and resources, including
budget and curriculum, and response to
meeting training criteria in OSHA’s
Hazardous Waste Operations and
Emergency Response Regulations (29
CFR 1910.120). As a cooperative
agreement, there are additional
requirements for the progress report
section of the application. Grantees are
to provide their information in hard
copy as well as enter information into
the WETP Grantee Data Management
System. The information collected is
used by the Director through officers,
employees, experts, and consultants to
evaluate applications based on technical
merit to determine whether to make
awards. Frequency of Response:
Biannual. Affected Public: Non-profit
organizations. Type of Respondents:
Grantees. The annual reporting burden
is as follows: Estimated Number of
Respondents: 18; Estimated Number of
Responses per Respondent: 2; Average
Burden Hours per Response: 14; and
Estimated Total Annual Burden Hours
Requested: 504. The annualized cost to
respondents is estimated at: $16,380.
There are no Capital Costs, Operating
Costs and/or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
E:\FR\FM\14APN1.SGM
14APN1
17196
Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
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: Joseph T. Hughes,
Jr., Director, Worker Education and
Training Branch, Division of Extramural
Research and Training, NIEHS, P.O. Box
12233, Research Triangle Park, NC
27709 or call non-toll-free number (919)
541–0217 or E-mail your request,
including your address to
wetp@niehs.nih.gov.
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.
Dated: April 2, 2009.
Marc S. Hollander,
NIEHS Associate Director for Management.
[FR Doc. E9–8472 Filed 4–13–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–P–0250] (formerly
Docket No. 2007P–0341)
Determination That ZOMETA
(Zoledronic Acid for Injection),
Equivalent to 4 Milligrams Base Per
Vial, Lyophilized Powder for Injection,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that ZOMETA (zoledronic acid for
injection), equivalent to (EQ) 4
milligrams (mg) base/vial, lyophilized
VerDate Nov<24>2008
16:39 Apr 13, 2009
Jkt 217001
powder for injection, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for zoledronic
acid lyophilized powder for injection, 4mg base/vial.
FOR FURTHER INFORMATION CONTACT:
Nancy Boocker, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is a version of the drug that was
previously approved. Sponsors of
ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under 21 CFR 314.161(a)(1), the
agency must determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness before
an ANDA that refers to that listed drug
may be approved. FDA may not approve
an ANDA that does not refer to a listed
drug.
ZOMETA (zoledronic acid for
injection), EQ 4-mg base/vial,
lyophilized powder for injection, is the
subject of approved NDA 21–223 held
by Novartis Pharmaceuticals Corp.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
(Novartis). Zoledronic acid, lyophilized
powder for injection, EQ 4-mg base/vial,
is indicated for treatment of
hypercalcemia of malignancy. It also is
indicated for the treatment of patients
with multiple myeloma and patients
with documented bone metastases from
solid tumors, in conjunction with
standard antineoplastic therapy.
Novartis ceased manufacturing
ZOMETA (zoledronic acid for injection),
EQ 4 mg-base/vial, lyophilized powder
for injection, in May 2003. On
September 13, 2007, Kendle
International, on behalf of Sun
Pharmaceutical Industries Ltd.,
submitted a citizen petition (Docket No.
2007P–0341/CP1), under 21 CFR 10.30,
requesting that the agency determine
whether zoledronic acid lyophilized
powder for injection, EQ 4-mg base/vial,
was withdrawn from sale for reasons of
safety or effectiveness.
The agency has determined that
ZOMETA (zoledronic acid for injection),
EQ 4-mg base/vial, lyophilized powder
for injection, was not withdrawn from
sale for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that zoledronic acid
lyophilized powder for injection, 4-mg
base/vial, was withdrawn from sale as a
result of safety or effectiveness
concerns. FDA’s independent
evaluation of relevant information has
uncovered no information that would
indicate this product was withdrawn for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing agency records, FDA
determines that for the reasons outlined
previously, ZOMETA (zoledronic acid
for injection), EQ 4-mg base/vial,
lyophilized powder for injection, was
not withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list ZOMETA
(zoledronic acid for injection), 4-mg
base/vial, lyophilized powder for
injection, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to ZOMETA
(zoledronic acid for injection), EQ 4-mg
base/vial, lyophilized powder for
injection, may be approved by the
agency as long as they meet all relevant
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that the labeling of this drug
product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
E:\FR\FM\14APN1.SGM
14APN1
Agencies
[Federal Register Volume 74, Number 70 (Tuesday, April 14, 2009)]
[Notices]
[Pages 17195-17196]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences, Division of
Extramural Research and Training; Proposed Collection; Comment Request
Hazardous Waste Worker Training
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 National Institute of
Environmental Health Sciences (NIEHS), 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: Hazardous Waste Worker Training--42 CFR
part 65. Type of Information Collection Request: Revision of OMB No.
0925-0348 and expiration date September 30, 2009. Need and Use of
Information Collection: This request for OMB review and approval of the
information collection is required by regulation 42 CFR part 65(a)(6).
The National Institute of Environmental Health Sciences (NIEHS) was
given major responsibility for initiating a worker safety and health
training program under Section 126 of the Superfund Amendments and
Reauthorization Act of 1986 (SARA) for hazardous waste workers and
emergency responders. A network of non-profit organizations that are
committed to protecting workers and their communities by delivering
high-quality, peer-reviewed safety and health curricula to target
populations of hazardous waste workers and emergency responders has
been developed. In twenty-one years (FY 1987-2008), the NIEHS Worker
Training program has successfully supported 20 primary grantees that
have trained more than 2.2 million workers across the country and
presented over 130,250 classroom and hands-on training courses, which
have accounted for nearly 30 million contact hours of actual training.
Generally, the grant will initially be for one year, and subsequent
continuation awards are also for one year at a time. Grantees must
submit a separate application to have the support continued for each
subsequent year. Grantees are to provide information in accordance with
S65.4(a), (b), (c) and 65.6(a) on the nature, duration, and purpose of
the training, selection criteria for trainees' qualifications and
competency of the project director and staff, cooperative agreements in
the case of joint applications, the adequacy of training plans and
resources, including budget and curriculum, and response to meeting
training criteria in OSHA's Hazardous Waste Operations and Emergency
Response Regulations (29 CFR 1910.120). As a cooperative agreement,
there are additional requirements for the progress report section of
the application. Grantees are to provide their information in hard copy
as well as enter information into the WETP Grantee Data Management
System. The information collected is used by the Director through
officers, employees, experts, and consultants to evaluate applications
based on technical merit to determine whether to make awards. Frequency
of Response: Biannual. Affected Public: Non-profit organizations. Type
of Respondents: Grantees. The annual reporting burden is as follows:
Estimated Number of Respondents: 18; Estimated Number of Responses per
Respondent: 2; Average Burden Hours per Response: 14; and Estimated
Total Annual Burden Hours Requested: 504. The annualized cost to
respondents is estimated at: $16,380. There are no Capital Costs,
Operating Costs and/or Maintenance Costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should
[[Page 17196]]
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: Joseph T. Hughes, Jr., Director, Worker Education
and Training Branch, Division of Extramural Research and Training,
NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-
toll-free number (919) 541-0217 or E-mail your request, including your
address to wetp@niehs.nih.gov.
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.
Dated: April 2, 2009.
Marc S. Hollander,
NIEHS Associate Director for Management.
[FR Doc. E9-8472 Filed 4-13-09; 8:45 am]
BILLING CODE 4140-01-P