Agency Forms Undergoing Paperwork Reduction Act Review, 69855-69856 [2013-27928]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 225 / Thursday, November 21, 2013 / Notices
69855
performed during the previous two
years.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
Emergency Epidemic Investigation Participants ...........
Emergency Epidemic Investigation
Data Collection Instruments.
12,000
1
30/60
LeRoy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Center for Disease Control and
Prevention.
[FR Doc. 2013–27942 Filed 11–20–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–14–0910]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
tkelley on DSK3SPTVN1PROD with NOTICES
Proposed Project
Message Testing for Tobacco
Communication Activities (OMB No.
0920–0910, exp. 1/31/2015)—
Revision—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 2012, CDC’s Office on Smoking and
Health (OSH) obtained OMB approval of
a generic clearance to support the
development of tobacco-related health
messages (Message Testing for Tobacco
VerDate Mar<15>2010
17:17 Nov 20, 2013
Jkt 232001
Communication Activities (MTTCA),
OMB No. 0920–0910, exp. 1/31/2015). A
variety of information collection
strategies are supported through this
generic mechanism, including in-depth
interviews, in-person focus groups,
online focus groups, computer-assisted,
in-person, or telephone interviews, and
online surveys. Each project approved
under the MTTCA framework is
outlined in a project-specific
Information Collection Request that
describes its purpose and methodology.
The MTTCA clearance has been used
to obtain OMB approval for a variety of
message testing activities, with
particular emphasis on communications
supporting CDC’s ‘‘Tips from Former
Smokers’’ campaign. This national
campaign, developed and implemented
by OSH, is designed to increase public
awareness of the health consequences of
tobacco use and exposure to
secondhand smoke. The MTTCA
clearance has also supported formative
research relating to the development of
health messages that are not specifically
associated with the national campaign.
In 2014, CDC will implement a new
phase of the national tobacco education
campaign and continue ongoing
programmatic initiatives, such as
maintaining the Media Campaign
Resource Center (MCRC) and producing
reports in conjunction with the Office of
the Surgeon General. OSH will continue
to use the MTTCA clearance to improve
the quality of tobacco-related health
messages associated with these
activities and other tobacco control
efforts of interest to CDC and its
partners. OSH anticipates that a number
of messages will be developed or refined
for subpopulations as well as the
general public. For example, screening
activities may be conducted to involve
individuals who are Lesbian, Gay,
Bisexual, and Transgender (LGBT);
individuals who are active military or
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
veterans; individuals who suffer from
depression and/or anxiety, and
individuals who are English-speaking
Hispanics. CDC may also request
information about smoking status (e.g.,
current non-smoker, current smoker, exsmoker).
CDC is requesting OMB approval to
revise the generic MTTCA clearance,
which was initially approved with the
following estimates: 5,775 annualized
burden hours and 14,974 annualized
responses. The initial estimates were
based on the number of respondents
who were likely to participate in
information collection activities such as
focus groups, interviews, and surveys.
The initial estimates did not specifically
account for screening activities that are
necessary to identify respondents from
key target audiences. As a result, the
initial MTTCA clearance
underestimated the total number of
responses needed to support data
collection conducted in 2012 and 2013.
The planned revision will adjust for
screening and recruitment by allocating
20,000 additional respondents, and 667
additional burden hours, to the
annualized estimates. To accommodate
both planned activities and potential
new initiatives or collaborations, CDC is
also requesting modest increases in the
number of respondents and burden
hours associated with survey activities.
CDC’s authority to collect information
for public health purposes is provided
by the Public Health Service Act (41
U.S.C. 241) Section 301.
The revision request does not affect
the current expiration date of January
31, 2015. The estimated annualized
number of responses will increase from
14,974 to 36,847 and the total estimated
annualized burden hours will increase
from 5,775 to 7,219. Participation is
voluntary and there are no costs to
respondents other than their time.
E:\FR\FM\21NON1.SGM
21NON1
69856
Federal Register / Vol. 78, No. 225 / Thursday, November 21, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Data collection method
General Public and Special Populations ........
Screening and Recruitment ...........................
In-depth Interviews (In Person, telephone,
etc.).
Focus Groups (In Person) .............................
Focus Groups (Online) ...................................
Short Surveys .................................................
(Online, Bulletin Board, etc.) ..........................
Medium Surveys ............................................
(Online) ...........................................................
In-depth Surveys (Online) ..............................
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. 2013–27928 Filed 11–20–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0573]
Determination That BANZEL
(Rufinamide) Tablet, 100 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 BANZEL (rufinamide) tablet, 100
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
rufinamide tablet, 100 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
Olivia Morris, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6260,
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 (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
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:17 Nov 20, 2013
Jkt 232001
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 (§ 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.
BANZEL (rufinamide) tablet, 100 mg,
is the subject of NDA 21–911, held by
Eisai Inc., and initially approved on
November 14, 2008. BANZEL is
indicated for adjunctive treatment of
seizures associated with Lennox-Gastaut
syndrome in children 4 years and older
and adults.
Eisai Inc., has never marketed
BANZEL (rufinamide) tablet, 100 mg. In
previous instances (see, e.g., 72 FR
9763, 61 FR 25497), the Agency has
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
20,000
67
1
1
2/60
1
160
120
6,500
1
1
1
1.5
1
10/60
8,500
1
25/60
1,500
1
1
determined that, for purposes of
§§ 314.161 and 314.162, never
marketing an approved drug product is
equivalent to withdrawing the drug
from sale.
Lupin Pharmaceuticals, Inc.,
submitted a citizen petition dated May
9, 2013 (Docket No. FDA–2013–P–
0573), under 21 CFR 10.30, requesting
that the Agency determine whether
BANZEL (rufinamide) tablet, 100 mg,
was withdrawn or discontinued 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 BANZEL (rufinamide)
tablet, 100 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that BANZEL
(rufinamide) tablet, 100 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of BANZEL
(rufinamide) tablet, 100 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list BANZEL (rufinamide)
tablet, 100 mg, 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 BANZEL
(rufinamide) tablet, 100 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[Federal Register Volume 78, Number 225 (Thursday, November 21, 2013)]
[Notices]
[Pages 69855-69856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27928]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-14-0910]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC or
by fax to (202) 395-5806. Written comments should be received within 30
days of this notice.
Proposed Project
Message Testing for Tobacco Communication Activities (OMB No. 0920-
0910, exp. 1/31/2015)--Revision--National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
In 2012, CDC's Office on Smoking and Health (OSH) obtained OMB
approval of a generic clearance to support the development of tobacco-
related health messages (Message Testing for Tobacco Communication
Activities (MTTCA), OMB No. 0920-0910, exp. 1/31/2015). A variety of
information collection strategies are supported through this generic
mechanism, including in-depth interviews, in-person focus groups,
online focus groups, computer-assisted, in-person, or telephone
interviews, and online surveys. Each project approved under the MTTCA
framework is outlined in a project-specific Information Collection
Request that describes its purpose and methodology.
The MTTCA clearance has been used to obtain OMB approval for a
variety of message testing activities, with particular emphasis on
communications supporting CDC's ``Tips from Former Smokers'' campaign.
This national campaign, developed and implemented by OSH, is designed
to increase public awareness of the health consequences of tobacco use
and exposure to secondhand smoke. The MTTCA clearance has also
supported formative research relating to the development of health
messages that are not specifically associated with the national
campaign.
In 2014, CDC will implement a new phase of the national tobacco
education campaign and continue ongoing programmatic initiatives, such
as maintaining the Media Campaign Resource Center (MCRC) and producing
reports in conjunction with the Office of the Surgeon General. OSH will
continue to use the MTTCA clearance to improve the quality of tobacco-
related health messages associated with these activities and other
tobacco control efforts of interest to CDC and its partners. OSH
anticipates that a number of messages will be developed or refined for
subpopulations as well as the general public. For example, screening
activities may be conducted to involve individuals who are Lesbian,
Gay, Bisexual, and Transgender (LGBT); individuals who are active
military or veterans; individuals who suffer from depression and/or
anxiety, and individuals who are English-speaking Hispanics. CDC may
also request information about smoking status (e.g., current non-
smoker, current smoker, ex-smoker).
CDC is requesting OMB approval to revise the generic MTTCA
clearance, which was initially approved with the following estimates:
5,775 annualized burden hours and 14,974 annualized responses. The
initial estimates were based on the number of respondents who were
likely to participate in information collection activities such as
focus groups, interviews, and surveys. The initial estimates did not
specifically account for screening activities that are necessary to
identify respondents from key target audiences. As a result, the
initial MTTCA clearance underestimated the total number of responses
needed to support data collection conducted in 2012 and 2013. The
planned revision will adjust for screening and recruitment by
allocating 20,000 additional respondents, and 667 additional burden
hours, to the annualized estimates. To accommodate both planned
activities and potential new initiatives or collaborations, CDC is also
requesting modest increases in the number of respondents and burden
hours associated with survey activities.
CDC's authority to collect information for public health purposes
is provided by the Public Health Service Act (41 U.S.C. 241) Section
301.
The revision request does not affect the current expiration date of
January 31, 2015. The estimated annualized number of responses will
increase from 14,974 to 36,847 and the total estimated annualized
burden hours will increase from 5,775 to 7,219. Participation is
voluntary and there are no costs to respondents other than their time.
[[Page 69856]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average
Type of respondents Data collection method Number of responses per burden per
respondents respondent response
----------------------------------------------------------------------------------------------------------------
General Public and Special Populations Screening and 20,000 1 2/60
Recruitment.
In-depth Interviews (In 67 1 1
Person, telephone,
etc.).
Focus Groups (In Person) 160 1 1.5
Focus Groups (Online)... 120 1 1
Short Surveys........... 6,500 1 10/60
(Online, Bulletin Board,
etc.).
Medium Surveys.......... 8,500 1 25/60
(Online)................
In-depth Surveys 1,500 1 1
(Online).
----------------------------------------------------------------------------------------------------------------
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. 2013-27928 Filed 11-20-13; 8:45 am]
BILLING CODE 4163-18-P
