Proposed Data Collections Submitted for Public Comment and Recommendations, 64200-64201 [2014-25562]
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64200
Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–25563 Filed 10–27–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15CI]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
asabaliauskas on DSK4SPTVN1PROD with NOTICES
The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited 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) ways to enhance the
quality, utility, and clarity of the
information to be collected; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
The respondents in this study will be
Congolese refugees 15 years of age or
older who have been referred for U.S.
resettlement in settlement and urban
sites in Uganda and who consent to a
supplemental mental health assessment
after their required overseas medical
exam or security screening interview.
Individual level data will not be
collected. Aggregated data will collected
during focus groups and surveys to form
a ‘profile’ of Congolese refugee
regarding their levels of anxiety,
depression, PTSD, ability to cope,
physical functioning, bodily pain, role
limitations due to physical health
problems, role limitations due to
personal or emotional problems,
emotional well-being, and social
function.
The focus group discussion tool poses
eight open-ended questions and will be
moderated by a professional in the
appropriate language for the specific
Congolese refugee group.
For the survey tool, CDC proposes to
the use a compilation of the Hopkins
Symptom Checklist, Harvard Trauma
Questionnaire, the Medical Outcomes
Assessment 36-Item Short-Form Health
Survey (SF–36), a limited number of
questions from The Coping Strategy
Indicator, and questions concerning
history of mental illness or substance
abuse. Each of these tools has been used
in similar populations that have
experienced trauma or in conflict
environments.
The sample population will be a
convenience sample of the Congolese
refugee population ages 15 or older in
Uganda and will be selected from the
available population being examined
during the International Organization
for Migration (IOM) medical or
Resettlement Support Center (RSC)
screening interviews. As refugees are
waiting for their IOM exam or RSC
interview, staff will introduce the
assessment with the help of an
interpreter, and make arrangements for
obtaining consent from refugees who
meet the inclusion and exclusion
criteria prior to the assessment.
There is no cost to respondents other
than their time. The total estimated
annualized burden hours are 386.
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Mental Health Profile of Congolese
Refugees—New—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The central objective of this collection
is to compile a mental health profile of
Congolese refugees departing from
Uganda, and to describe some of the
mental health conditions most often
experienced by this population. The
specific objectives are (1) through a
survey and focus groups, collect more
detailed and systematic data on
exposure to trauma and symptoms of
PTSD, anxiety, and depression among a
sample of Congolese refugees from
Uganda prior to their resettlement in the
United States; and, (2) to better inform
state and local healthcare providers in
the United States and in Uganda about
the mental health needs of the
Congolese refugee populations come to
their states. As CDC have seen in
previous surveys, although there may be
similarities in the mental health
problems that refugee populations may
experience over all, there are also very
specific differences in terms of cultural
background, coping styles, severity, and
risk factors. Without doing a survey, it
would not be possible to provide
specific recommendations for Congolese
refugees who are coming to the U.S.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Refugee .................................
Refugee .................................
Focus Group Discussion Tool ......................
Survey Tool ..................................................
VerDate Sep<11>2014
20:06 Oct 27, 2014
Jkt 235001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
16
370
E:\FR\FM\28OCN1.SGM
1
1
28OCN1
Average
burden per
response
(in hours)
Total burden
hours
1
1
16
370
Federal Register / Vol. 79, No. 208 / Tuesday, October 28, 2014 / Notices
64201
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
.......................................................................
........................
........................
........................
Type of respondents
Total ...............................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–25562 Filed 10–27–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–P–0979]
Determination That DIAMOX
(Acetazolamide) Intravenous, 500
Milligrams Base/Vial, and DIAMOX
(Acetazolamide) Tablets, 125
Milligrams and 250 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) has determined
that DIAMOX (acetazolamide)
intravenous, 500 milligrams (mg) base/
vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 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 these drug
products, and it will allow FDA to
continue to approve ANDAs that refer to
these products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6228, Silver Spring,
MD 20993–0002, 240–402–4191.
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
asabaliauskas on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:06 Oct 27, 2014
Jkt 235001
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
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 (§ 314.162 (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.
DIAMOX (acetazolamide)
intravenous, 500 mg base/vial, is the
subject of NDA 009–388, held by Teva
Branded Pharmaceutical Products R&D,
Inc., and initially approved on June 25,
1954. DIAMOX (acetazolamide) tablets,
125 mg and 250 mg, are the subject of
NDA 008–943, held by Teva Branded
Pharmaceutical Products R&D, Inc., and
initially approved on July 27, 1953.
DIAMOX (acetazolamide) intravenous,
500 mg base/vial, and DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, are indicated for adjunctive
treatment of: Edema due to congestive
heart failure; drug-induced edema;
centrencephalic epilepsies (petit mal,
unlocalized seizures); and chronic
simple (open-angle) glaucoma,
secondary glaucoma, and preoperatively
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Total burden
hours
386
in acute angle-closure glaucoma where
delay of surgery is desired in order to
lower intraocular pressure. DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 mg, are also
indicated for the prevention or
amelioration of symptoms associated
with acute mountain sickness in
climbers attempting rapid ascent and in
those who are very susceptible to acute
mountain sickness despite gradual
ascent.
DIAMOX (acetazolamide)
intravenous, 500 mg base/vial, and
DIAMOX (acetazolamide) tablets, 125
mg and 250 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Emcure Pharmaceuticals USA, Inc.,
submitted a citizen petition dated July
3, 2014 (Docket No. FDA–2014–P–
0979), under 21 CFR 10.30, requesting
that the Agency determine that
DIAMOX (acetazolamide) intravenous,
500 mg base/vial, was discontinued for
reasons unrelated to safety and
effectiveness. Although the citizen
petition did not address DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, since those products have also been
discontinued, on our own initiative, we
therefore determined whether DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, were withdrawn for safety or
effectiveness reasons.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
DIAMOX (acetazolamide) intravenous,
500 mg base/vial, and DIAMOX
(acetazolamide) tablets, 125 mg and 250
mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, was withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of DIAMOX
(acetazolamide) intravenous, 500 mg
base/vial, and DIAMOX (acetazolamide)
tablets, 125 mg and 250 mg from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that these products were
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 79, Number 208 (Tuesday, October 28, 2014)]
[Notices]
[Pages 64200-64201]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25562]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-15CI]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC), as part of
its continuing effort to reduce public burden, invites the general
public and other Federal agencies to take this opportunity to comment
on proposed and/or continuing information collections, as required by
the Paperwork Reduction Act of 1995. To request more information on the
below proposed project or to obtain a copy of the information
collection plan and instruments, call 404-639-7570 or send comments to
Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or
send an email to omb@cdc.gov.
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
(OMB) approval. Comments are invited 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) ways to
enhance the quality, utility, and clarity of the information to be
collected; (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; and (e)
estimates of capital or start-up costs and costs of operation,
maintenance, and purchase of services to provide information. Burden
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, disclose or provide information
to or for a Federal agency. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information; and to transmit or otherwise
disclose the information. Written comments should be received within 60
days of this notice.
Proposed Project
Mental Health Profile of Congolese Refugees--New--National Center
for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The central objective of this collection is to compile a mental
health profile of Congolese refugees departing from Uganda, and to
describe some of the mental health conditions most often experienced by
this population. The specific objectives are (1) through a survey and
focus groups, collect more detailed and systematic data on exposure to
trauma and symptoms of PTSD, anxiety, and depression among a sample of
Congolese refugees from Uganda prior to their resettlement in the
United States; and, (2) to better inform state and local healthcare
providers in the United States and in Uganda about the mental health
needs of the Congolese refugee populations come to their states. As CDC
have seen in previous surveys, although there may be similarities in
the mental health problems that refugee populations may experience over
all, there are also very specific differences in terms of cultural
background, coping styles, severity, and risk factors. Without doing a
survey, it would not be possible to provide specific recommendations
for Congolese refugees who are coming to the U.S.
The respondents in this study will be Congolese refugees 15 years
of age or older who have been referred for U.S. resettlement in
settlement and urban sites in Uganda and who consent to a supplemental
mental health assessment after their required overseas medical exam or
security screening interview.
Individual level data will not be collected. Aggregated data will
collected during focus groups and surveys to form a `profile' of
Congolese refugee regarding their levels of anxiety, depression, PTSD,
ability to cope, physical functioning, bodily pain, role limitations
due to physical health problems, role limitations due to personal or
emotional problems, emotional well-being, and social function.
The focus group discussion tool poses eight open-ended questions
and will be moderated by a professional in the appropriate language for
the specific Congolese refugee group.
For the survey tool, CDC proposes to the use a compilation of the
Hopkins Symptom Checklist, Harvard Trauma Questionnaire, the Medical
Outcomes Assessment 36-Item Short-Form Health Survey (SF-36), a limited
number of questions from The Coping Strategy Indicator, and questions
concerning history of mental illness or substance abuse. Each of these
tools has been used in similar populations that have experienced trauma
or in conflict environments.
The sample population will be a convenience sample of the Congolese
refugee population ages 15 or older in Uganda and will be selected from
the available population being examined during the International
Organization for Migration (IOM) medical or Resettlement Support Center
(RSC) screening interviews. As refugees are waiting for their IOM exam
or RSC interview, staff will introduce the assessment with the help of
an interpreter, and make arrangements for obtaining consent from
refugees who meet the inclusion and exclusion criteria prior to the
assessment.
There is no cost to respondents other than their time. The total
estimated annualized burden hours are 386.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Refugee....................... Focus Group 16 1 1 16
Discussion Tool.
Refugee....................... Survey Tool..... 370 1 1 370
---------------------------------------------------------------
[[Page 64201]]
Total..................... ................ .............. .............. .............. 386
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-25562 Filed 10-27-14; 8:45 am]
BILLING CODE 4163-18-P
