Proposed Data Collections Submitted for Public Comment and Recommendations, 66008-66009 [2013-26277]
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Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices
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[FR Doc. 2013–26291 Filed 11–1–13; 8:45 am]
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17:07 Nov 01, 2013
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–14BB]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
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; 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. Written comments should
be received within 60 days of this
notice.
Proposed Project:
Evaluation of Rapid HIV HomeTesting among MSM Trial—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Innovative testing strategies are
needed to reduce levels of undiagnosed
Human immunodeficiency virus (HIV)
infection and increase early access to
treatment. Rapid home HIV tests may
play an important role in efforts to
reduce both HIV morbidity and
mortality. Given the unrelenting HIV
crisis among men who have sex with
men (MSM) and the release into the
market of a rapid HIV test for at-home
use, it is necessary to evaluate the
impact of providing rapid HIV hometest kits on repeat HIV testing, linkage
to care, partner testing, serosorting, and
HIV sexual risk behaviors among MSM.
PO 00000
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Sfmt 4703
This information will assist the Division
of HIV/AIDS Prevention (DHAP) in
developing recommendations, future
research and program needs concerning
home-testing for MSM.
Specific Aims
This study is a randomized trial
which aims to evaluate the use and
effectiveness of home-test kits as a
public health strategy for increasing
testing among MSM. A secondary aim of
the randomized trial is to evaluate the
extent to which MSM (both HIVnegative and HIV-positive) distribute
HIV home-test kits to their social and
sexual networks.
The population for the randomized
trial will be men over the age of 18 years
who self-report that they have had anal
sex with at least one man in the past
year. We will recruit approximately
3,200 men who report their HIV status
to be negative or who are unaware of
their HIV status and 300 men who selfreport that they are HIV-positive. Men
will be recruited from the 12 cities:
Atlanta, Georgia; Baltimore, Maryland;
Chicago, Illinois; Dallas, Texas; District
of Columbia; Houston, Texas; Los
Angeles, California; Miami, Florida;
New York City, New York; Philadelphia,
Pennsylvania; San Francisco, California;
and San Juan, Puerto Rico. We will
ensure that at least 20% of participants
are black and at least 15% are Hispanic.
Recruitment will be conducted through
banner advertisements displayed on
social networking sites such as
Facebook and dating and sex-seeking
sites such as Manhunt and
Adam4Adam.
This study also has a qualitative
component that aims to examine the
experiences of participants in the
randomized control trial (RCT).
Participants for the qualitative data
collection will be drawn from the
randomized control trial. Two data
collection techniques will be used:
focus group discussions (FGD) (both
online and in-person) and individual indepth interviews (IDIs).
CDC is requesting approval for a 3year clearance for data collection. All
participant consenting and data
collection for the RCT will be completed
using an online reporting system. Data
will be collected using an eligibility
screener, an online study registration
process, a baseline survey, HIV test
results reporting system, and follow-up
surveys. Men will be asked to use the
study Web site or download and access
a secure cell phone application prior to
enter results of their rapid HIV hometests that they receive and conduct at
home and to take the follow-up surveys
which will collect information on HIV
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66009
Federal Register / Vol. 78, No. 213 / Monday, November 4, 2013 / Notices
testing results and behaviors and sexual
activities. Focus group discussions and
in-depth interviews will be used to
examine experiences of participants in
the RCT.
focus group discussion 1 hour and 30
minutes; and the in-depth interviews 1
hour and 15 minutes.
There is no cost to participants other
than their time.
The duration of the eligibility
screener is estimated to be 5 minutes;
the study registration process 5 minutes;
the baseline survey 15 minutes; the
reporting of home-test results 5 minutes;
the follow-up surveys 10 minutes; the
Number of
responses per
respondent
Number of
respondents
Average
hours per
response
Total
response
burden
(hours)
Type of respondent
Form name
Prospective Participant .....................
Enrolled participant ...........................
Enrolled participant ...........................
Enrolled participant ...........................
24,000
14,000
3,200
300
1
1
1
1
3/60
5/60
15/60
15/60
1,200
1,167
800
75
1,600
3
5/60
400
3,200
300
4
2
10/60
10/60
2,133
100
3,200
1
5/60
267
Enrolled participant ...........................
Enrolled participant ...........................
Eligibility Screener ............................
Study Registration ............................
Baseline Survey for RCT .................
Baseline Survey for HIV-positive
group.
Reporting of Home-test Results during study.
Follow-up Surveys for RCT ..............
Follow-up Surveys for HIV positive
group.
Reporting of Home-test Results at
completion of study.
Focus group discussion ...................
Individual in-depth interview guide ...
216
30
1
1
1.5
1.5
324
45
Total ...........................................
...........................................................
........................
........................
........................
6,511
Enrolled participant ...........................
Enrolled participant ...........................
Enrolled participant ...........................
Enrolled participants .........................
Leroy 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. 2013–26277 Filed 11–1–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0775]
Determination That INVEGA
(Paliperidone) Extended-Release
Tablet, 12 Milligrams, Was 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 INVEGA (paliperidone) extendedrelease tablet, 12 milligrams (mg), was
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for paliperidone
extended-release tablet, 12 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Linda Jong, Center for Drug Evaluation
and Research, Food and Drug
TKELLEY on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:07 Nov 01, 2013
Jkt 232001
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6224, Silver Spring,
MD 20993–0002, 301–796–3977.
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
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).
SUPPLEMENTARY INFORMATION:
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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.
INVEGA (paliperidone) extendedrelease tablet, 12 mg, is the subject of
NDA 21–999, held by Janssen
Pharmaceuticals, Inc., and initially
approved on December 19, 2006.
INVEGA extended-release tablets are
indicated for the treatment of
schizophrenia and the treatment of
schizoaffective disorder as monotherapy
and as an adjunct to mood stabilizers
and/or antidepressants.
Janssen Pharmaceuticals, Inc., has
never marketed INVEGA (paliperidone)
extended-release tablet, 12 mg. In
previous instances (see, e.g., 72 FR
9763, 61 FR 25497), the Agency has
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale. The other strengths of
INVEGA (paliperidone) that are
approved under NDA 21–999 are being
marketed.
Hyman, Phelps & McNamara, P.C.,
submitted a citizen petition dated June
25, 2013 (Docket No. FDA–2013–P–
0775), under 21 CFR 10.30, requesting
that the Agency determine whether
E:\FR\FM\04NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66008-66009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26277]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-14-14BB]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to LeRoy Richardson, 1600 Clifton Road, MS-D74, Atlanta,
GA 30333 or send an email to omb@cdc.gov.
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; 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. Written comments should be received
within 60 days of this notice.
Proposed Project:
Evaluation of Rapid HIV Home-Testing among MSM Trial--New--National
Center for HIV/AIDS, Viral Hepatitis, STD, TB Prevention (NCHHSTP),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Innovative testing strategies are needed to reduce levels of
undiagnosed Human immunodeficiency virus (HIV) infection and increase
early access to treatment. Rapid home HIV tests may play an important
role in efforts to reduce both HIV morbidity and mortality. Given the
unrelenting HIV crisis among men who have sex with men (MSM) and the
release into the market of a rapid HIV test for at-home use, it is
necessary to evaluate the impact of providing rapid HIV home-test kits
on repeat HIV testing, linkage to care, partner testing, serosorting,
and HIV sexual risk behaviors among MSM. This information will assist
the Division of HIV/AIDS Prevention (DHAP) in developing
recommendations, future research and program needs concerning home-
testing for MSM.
Specific Aims
This study is a randomized trial which aims to evaluate the use and
effectiveness of home-test kits as a public health strategy for
increasing testing among MSM. A secondary aim of the randomized trial
is to evaluate the extent to which MSM (both HIV-negative and HIV-
positive) distribute HIV home-test kits to their social and sexual
networks.
The population for the randomized trial will be men over the age of
18 years who self-report that they have had anal sex with at least one
man in the past year. We will recruit approximately 3,200 men who
report their HIV status to be negative or who are unaware of their HIV
status and 300 men who self-report that they are HIV-positive. Men will
be recruited from the 12 cities: Atlanta, Georgia; Baltimore, Maryland;
Chicago, Illinois; Dallas, Texas; District of Columbia; Houston, Texas;
Los Angeles, California; Miami, Florida; New York City, New York;
Philadelphia, Pennsylvania; San Francisco, California; and San Juan,
Puerto Rico. We will ensure that at least 20% of participants are black
and at least 15% are Hispanic. Recruitment will be conducted through
banner advertisements displayed on social networking sites such as
Facebook and dating and sex-seeking sites such as Manhunt and
Adam4Adam.
This study also has a qualitative component that aims to examine
the experiences of participants in the randomized control trial (RCT).
Participants for the qualitative data collection will be drawn from the
randomized control trial. Two data collection techniques will be used:
focus group discussions (FGD) (both online and in-person) and
individual in-depth interviews (IDIs).
CDC is requesting approval for a 3-year clearance for data
collection. All participant consenting and data collection for the RCT
will be completed using an online reporting system. Data will be
collected using an eligibility screener, an online study registration
process, a baseline survey, HIV test results reporting system, and
follow-up surveys. Men will be asked to use the study Web site or
download and access a secure cell phone application prior to enter
results of their rapid HIV home-tests that they receive and conduct at
home and to take the follow-up surveys which will collect information
on HIV
[[Page 66009]]
testing results and behaviors and sexual activities. Focus group
discussions and in-depth interviews will be used to examine experiences
of participants in the RCT.
The duration of the eligibility screener is estimated to be 5
minutes; the study registration process 5 minutes; the baseline survey
15 minutes; the reporting of home-test results 5 minutes; the follow-up
surveys 10 minutes; the focus group discussion 1 hour and 30 minutes;
and the in-depth interviews 1 hour and 15 minutes.
There is no cost to participants other than their time.
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Form name Number of responses per Average hours Total response
respondents respondent per response burden (hours)
----------------------------------------------------------------------------------------------------------------
Prospective Participant....... Eligibility 24,000 1 3/60 1,200
Screener.
Enrolled participant.......... Study 14,000 1 5/60 1,167
Registration.
Enrolled participant.......... Baseline Survey 3,200 1 15/60 800
for RCT.
Enrolled participant.......... Baseline Survey 300 1 15/60 75
for HIV-
positive group.
Enrolled participant.......... Reporting of 1,600 3 5/60 400
Home-test
Results during
study.
Enrolled participant.......... Follow-up 3,200 4 10/60 2,133
Surveys for RCT.
Enrolled participant.......... Follow-up 300 2 10/60 100
Surveys for HIV
positive group.
Enrolled participants......... Reporting of 3,200 1 5/60 267
Home-test
Results at
completion of
study.
Enrolled participant.......... Focus group 216 1 1.5 324
discussion.
Enrolled participant.......... Individual in- 30 1 1.5 45
depth interview
guide.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 6,511
----------------------------------------------------------------------------------------------------------------
Leroy 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. 2013-26277 Filed 11-1-13; 8:45 am]
BILLING CODE 4163-18-P
