Draft-National Occupational Research Agenda for Transportation, Warehousing and Utilities, 56973-56974 [2017-25876]
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Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
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1. McGehee Bank Employee Stock
Ownership Plan, McGehee, Arkansas; to
acquire additional voting shares for a
total of 35 percent, of Southeast
Financial Bankstock Corp., and thereby
indirectly acquire shares of McGehee
Bank, both of McGehee, Arkansas.
Board of Governors of the Federal Reserve
System, November 28, 2017.
Ann E. Misback,
Secretary of the Board.
Dated: November 27, 2017.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2017–25908 Filed 11–30–17; 8:45 am]
[FR Doc. 2017–25873 Filed 11–30–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 6210–01–P
BILLING CODE 6714–01–P
Centers for Disease Control and
Prevention
FEDERAL RESERVE SYSTEM
[Docket Number CDC–2017–0114, NIOSH–
305]
sradovich on DSK3GMQ082PROD with NOTICES
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have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR 225),
and all other applicable statutes and
regulations to become a bank holding
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writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
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2017.
A. Federal Reserve Bank of St. Louis
(David L. Hubbard, Senior Manager)
VerDate Sep<11>2014
16:44 Nov 30, 2017
Jkt 244001
Draft—National Occupational Research
Agenda for Transportation,
Warehousing and Utilities
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Request for comment.
AGENCY:
The National Institute for
Occupational Safety and Health of the
Centers for Disease Control and
Prevention announces the availability of
a draft NORA Agenda entitled National
Occupational Research Agenda for
Transportation, Warehousing and
Utilities for public comment. To view
the notice and related materials, visit
https://www.regulations.gov and enter
CDC–2017–0114 in the search field and
click ‘‘Search.’’
SUMMARY:
Table of Contents
Dates
Addresses
For Further Information Contact
Supplementary Information
Background
Electronic or written comments
must be received by January 30, 2018.
ADDRESSES: You may submit comments,
identified by CDC–2017–0114 and
docket number NIOSH–305, by any of
the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
DATES:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
56973
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All submissions received
in response to this notice must include
the agency name and docket number
[CDC–2017–0114; NIOSH–305]. All
relevant comments received will be
posted without change to https://
www.regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov. All
information received in response to this
notice will also be available for public
examination and copying at the NIOSH
Docket Office, 1150 Tusculum Avenue,
Room 155, Cincinnati, OH 45226–1998.
FOR FURTHER INFORMATION CONTACT:
Emily Novicki (NORACoordinator@
cdc.gov), National Institute for
Occupational Safety and Health, Centers
for Disease Control and Prevention,
Mailstop E–20, 1600 Clifton Road NE.,
Atlanta, GA 30329, phone (404) 498–
2581 (not a toll free number).
SUPPLEMENTARY INFORMATION: The
National Occupational Research Agenda
(NORA) is a partnership program
created to stimulate innovative research
and improved workplace practices. The
national agenda is developed and
implemented through the NORA sector
and cross-sector councils. Each council
develops and maintains an agenda for
its sector or cross-sector.
Background: The National
Occupational Research Agenda for
Transportation, Warehousing and
Utilities (TWU) is intended to identify
the research, information, and actions
most urgently needed to prevent
occupational illnesses and injuries in
the TWU sector. The National
Occupational Research Agenda for TWU
provides a vehicle for stakeholders to
describe the most relevant issues, gaps,
and safety and health needs for the
sector. Each NORA research agenda is
meant to guide or promote high priority
research efforts on a national level,
conducted by various entities,
including: Government, higher
education, and the private sector.
The first National Occupational
Research Agenda for TWU was
published in 2009 for the second decade
of NORA (2006–2016). This draft is an
updated agenda for the third decade of
NORA (2016–2026). The revised agenda
was developed considering new
information about injuries and illnesses,
the state of the science, and the
probability that new information and
approaches will make a difference. As
the steward of the NORA process,
NIOSH invites comments on the draft
National Occupational Research
E:\FR\FM\01DEN1.SGM
01DEN1
56974
Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
Agenda for TWU. Comments expressing
support or with specific
recommendations to improve the
Agenda are requested. A copy of the
draft Agenda is available at https://
www.regulations.gov (see Docket
Number CDC–2017–0114).
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2017–25876 Filed 11–30–17; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–P–4027]
Determination That METICORTEN
(Prednisone) Tablets, 1 Milligram and 5
Milligrams, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that METICORTEN
(prednisone) tablets, 1 milligram (mg)
and 5 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
This determination means that FDA will
not begin procedures to withdraw
approval of abbreviated new drug
applications (ANDAs) that refer to this
drug product, and it will allow FDA to
continue to approve ANDAs that refer to
the product as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Meadow Platt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
Silver Spring, MD 20993–0002, 301–
796–1830, Meadow.Platt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
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. ANDA applicants
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:44 Nov 30, 2017
Jkt 244001
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
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 known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed 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).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
METICORTEN (prednisone) tablets, 1
mg and 5 mg, are the subject of NDA
09–766, held by Schering Corporation
(Schering), and initially approved on
February 21, 1955. METICORTEN is
indicated for the following:
1. Allergic states: Control of severe or
incapacitating allergic conditions
intractable to adequate trials of
conventional treatment in asthma,
atopic dermatitis, contact dermatitis,
drug hypersensitivity reactions,
perennial or seasonal allergic rhinitis,
serum sickness;
2. Dermatologic diseases: Bullous
dermatitis herpetiformis, exfoliative
erythroderma, mycosis fungoides,
pemphigus, severe erythema multiforme
(Stevens-Johnson syndrome);
3. Endocrine disorders: Primary or
secondary adrenocortical insufficiency
(hydrocortisone or cortisone is the drug
of choice; synthetic analogs may be used
in conjunction with mineralocorticoids
where applicable; in infancy,
mineralocorticoid supplementation is of
particular importance), congenital
adrenal hyperplasia, hypercalcemia
associated with cancer, nonsuppurative
thyroiditis;
4. Gastrointestinal diseases: To tide
the patient over a critical period of the
disease in regional enteritis and
ulcerative colitis;
5. Hematologic disorders: Acquired
(autoimmune) hemolytic anemia,
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Diamond-Blackfan anemia, idiopathic
thrombocytopenic purpura in adults,
pure red cell aplasia, selected cases of
secondary thrombocytopenia;
6. Miscellaneous: Trichinosis with
neurologic or myocardial involvement,
tuberculous meningitis with
subarachnoid block or impending block
when used with appropriate
antituberculous chemotherapy;
7. Neoplastic diseases: For the
palliative management of leukemias and
lymphomas;
8. Nervous system: Acute
exacerbations of multiple sclerosis;
cerebral edema associated with primary
or metastatic brain tumor, craniotomy,
or head injury;
9. Ophthalmic diseases: Sympathetic
ophthalmia, temporal arteritis, uveitis
and ocular inflammatory conditions
unresponsive to topical corticosteroids;
10. Renal diseases: To induce diuresis
or remission of proteinuria in idiopathic
nephrotic syndrome or that due to lupus
erythematosus;
11. Respiratory diseases: Berylliosis,
fulminating or disseminated pulmonary
tuberculosis when used concurrently
with appropriate antituberculous
chemotherapy, idiopathic eosinophilic
pneumonias, symptomatic sarcoidosis;
and
12. Rheumatic disorders: As
adjunctive therapy for short-term
administration (to tide the patient over
an acute episode or exacerbation) in
acute gouty arthritis; acute rheumatic
carditis; ankylosing spondylitis;
psoriatic arthritis; rheumatoid arthritis,
including juvenile rheumatoid arthritis
(selected cases may require low-dose
maintenance therapy). For the treatment
of dermatomyositis, polymyositis, and
systemic lupus erythematosus.
In a letter dated November 1, 2001,
Schering requested withdrawal of NDA
09–766 for METICORTEN (prednisone).
In the Federal Register of October 10,
2002 (67 FR 63107), FDA announced
that it was withdrawing approval of
NDA 09–766, effective November 12,
2002.
Strides Pharma, Inc., submitted a
citizen petition dated July 1, 2017
(Docket No. FDA–2017–P–4027), under
21 CFR 10.30, requesting that the
Agency determine whether
METICORTEN (prednisone) tablets, 1
mg and 5 mg, were withdrawn from sale
for reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that METICORTEN
(prednisone) tablets, 1 mg and 5 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
E:\FR\FM\01DEN1.SGM
01DEN1
Agencies
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56973-56974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25876]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number CDC-2017-0114, NIOSH-305]
Draft--National Occupational Research Agenda for Transportation,
Warehousing and Utilities
AGENCY: National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Request for comment.
-----------------------------------------------------------------------
SUMMARY: The National Institute for Occupational Safety and Health of
the Centers for Disease Control and Prevention announces the
availability of a draft NORA Agenda entitled National Occupational
Research Agenda for Transportation, Warehousing and Utilities for
public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2017-0114 in the search field and
click ``Search.''
Table of Contents
Dates
Addresses
For Further Information Contact
Supplementary Information
Background
DATES: Electronic or written comments must be received by January 30,
2018.
ADDRESSES: You may submit comments, identified by CDC-2017-0114 and
docket number NIOSH-305, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: National Institute for Occupational Safety and
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati,
Ohio 45226-1998.
Instructions: All submissions received in response to this notice
must include the agency name and docket number [CDC-2017-0114; NIOSH-
305]. All relevant comments received will be posted without change to
https://www.regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to https://www.regulations.gov. All information
received in response to this notice will also be available for public
examination and copying at the NIOSH Docket Office, 1150 Tusculum
Avenue, Room 155, Cincinnati, OH 45226-1998.
FOR FURTHER INFORMATION CONTACT: Emily Novicki
(NORACoordinator@cdc.gov), National Institute for Occupational Safety
and Health, Centers for Disease Control and Prevention, Mailstop E-20,
1600 Clifton Road NE., Atlanta, GA 30329, phone (404) 498-2581 (not a
toll free number).
SUPPLEMENTARY INFORMATION: The National Occupational Research Agenda
(NORA) is a partnership program created to stimulate innovative
research and improved workplace practices. The national agenda is
developed and implemented through the NORA sector and cross-sector
councils. Each council develops and maintains an agenda for its sector
or cross-sector.
Background: The National Occupational Research Agenda for
Transportation, Warehousing and Utilities (TWU) is intended to identify
the research, information, and actions most urgently needed to prevent
occupational illnesses and injuries in the TWU sector. The National
Occupational Research Agenda for TWU provides a vehicle for
stakeholders to describe the most relevant issues, gaps, and safety and
health needs for the sector. Each NORA research agenda is meant to
guide or promote high priority research efforts on a national level,
conducted by various entities, including: Government, higher education,
and the private sector.
The first National Occupational Research Agenda for TWU was
published in 2009 for the second decade of NORA (2006-2016). This draft
is an updated agenda for the third decade of NORA (2016-2026). The
revised agenda was developed considering new information about injuries
and illnesses, the state of the science, and the probability that new
information and approaches will make a difference. As the steward of
the NORA process, NIOSH invites comments on the draft National
Occupational Research
[[Page 56974]]
Agenda for TWU. Comments expressing support or with specific
recommendations to improve the Agenda are requested. A copy of the
draft Agenda is available at https://www.regulations.gov (see Docket
Number CDC-2017-0114).
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2017-25876 Filed 11-30-17; 8:45 am]
BILLING CODE 4163-19-P