Agency Forms Undergoing Paperwork Reduction Act Review, 52771-52772 [2013-20643]
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52771
Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
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. 2013–20645 Filed 8–23–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-13–13RE]
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 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Public Health Systems, Mental Health
and Community Recovery Project—
New—Office of Public Health
Preparedness and Response, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
This project stems from, and aligns
with, publication of the Office of Public
Health Preparedness and Response’s
(OPHPR) ‘‘National Strategic Plan for
Public Health Preparedness and
Response’’ which provides overall
direction for Centers for Disease Control
and Prevention’s (CDC) preparedness
and response portfolio, including
programmatic direction across OPHPR’s
four divisions. The focus of this project
is to generate findings useful for future
preparedness planning and response in
order to develop strategies and
interventions aimed at mitigating the
impact of adverse events. In April 2011,
one of the largest tornado outbreaks ever
recorded, a ‘‘Super Outbreak,’’ occurred
in the southeastern United States,
resulting in more than 300 deaths and
an estimated $10 billion in damages.
This large-scale multistate tragedy offers
a unique opportunity to study how
communities with similar cultural and
geographic features yet different public
health and mental health emergency
response systems could provide access
to care around the same crisis. The
outcomes of these efforts can inform the
field of what effect these differences had
on the recovery patterns of each of these
communities. By doing so, we can begin
to elucidate best practices for robust
community preparedness and recovery
with attention to types of services that
most effectively promote the natural
resilience of survivors. Two primary
research questions will guide the
proposed study:
1. How did the Alabama and
Mississippi State and local public
health and mental health (PH/MH)
systems prepare for, respond to, and
support recovery after the April 2011
tornados?
2. To what extent have these
communities recovered and what is the
overall health and quality of life of
individuals affected by these events?
CDC requests OMB approval to collect
information for two years.
To address these questions, CDC, in
collaboration with ICF International,
will conduct a mixed method evaluation
utilizing key informant interviews of
public health and mental health agency
staff and other leaders from the
community and household survey data
in each of the four regions in
Mississippi and Alabama to assess
community recovery. Specifically, the
study design includes two main
components (qualitative and
quantitative) designed to
comprehensively examine the PH/MH
system response to and community
recovery and resilience from disasters.
The total estimated burden for the 98
one-time qualitative interviews for
public health/mental health
professionals and community leaders is
98 hours (98 respondents × 1 hour/
response). Interviews will be conducted
during an in-person site-visit to the
region to reduce travel and time burdens
on the respondents. Respondents unable
to participate during the site visit may
participate via telephone. In addition,
the total estimated burden for the
quantitative computer-assisted
interviews are based on 1,313 screener
respondents and 860 survey
respondents in each of the four tornado
effected regions; the screener will take
approximately 2 minutes to complete
and the survey will take approximately
25 minutes to complete.(Study Screener:
4 counties × 1,313 study screeners =
5,252 participants screened; 5,252
participants × 2/60 minutes = 175 hours;
Household Survey for General Public: 4
counties × 860 respondents = 3,440
respondents; 3,440 respondents × 25/60
minutes = 1,433 hours).
There are no costs to respondents
other than their time.
The total estimated annual burden
hours are 1,706.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Mental Health/Public Health Agency Staff ......
Key Informant Interview Guide_PH/MH
Agency Staff & Key Informant Interview
Guide_Consent Form.
Key Informant Interview Guide_Community
Organization Respondents & Key Informant Interview Guide_Consent Form.
Household Survey for General Public and
Consent.
Household Survey for General Public_Study
Screener.
ehiers on DSK2VPTVN1PROD with NOTICES
Community Organization Leaders ..................
General public from disaster affected communities.
General public from disaster affected communities.
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E:\FR\FM\26AUN1.SGM
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
53
1
1
45
1
1
3,440
1
25/60
5,252
1
2/60
26AUN1
52772
Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices
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. 2013–20643 Filed 8–23–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0450]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Abbreviated New
Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
25, 2013.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0669 and
title ‘‘Abbreviated New Animal Drug
Applications.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Abbreviated New Animal Drug
Applications—Section 512(b)(2) and
(n)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1)) (OMB Control Number 0910–
0669)—Extension
On November 16, 1988, the President
signed into law the Generic Animal
Drug and Patent Restoration Act
(GADPTRA) (Pub. L. 100–670). Under
section 512(b)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by GADPTRA, any person
may file an abbreviated new animal
drug application (ANADA) seeking
approval of a generic copy of an
approved new animal drug. The
information required to be submitted as
part of an abbreviated application is
described in section 512(n)(1) of the
FD&C Act. Among other things, an
abbreviated application is required to
contain information to show that the
proposed generic drug is bioequivalent
to, and has the same labeling as, the
approved drug referenced in the
abbreviated application. FDA allows
applicants to submit a complete
ANADA or to submit information in
support of an ANADA for phased
review followed by the submission of an
Administrative ANADA when FDA
finds that all the applicable technical
sections for an ANADA are complete.
FDA requests that an applicant
accompany ANADAs and requests for
phased review of data to support
ANADAs with the Form FDA 356v to
ensure efficient and accurate processing
of information to support approval of
the generic new animal drug.
In the Federal Register of April 30,
2013 (78 FR 25279), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received; however the comment was not
responsive to any of the four topics
solicited by the notice. Therefore, FDA
does not address the comment here.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ANADAS: ESTIMATED ANNUAL REPORTING BURDEN
FD&C act section 512 (b)(2)
FDA form
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
ANADA ...................................................
Phased Review With Administrative
ANADA ...............................................
356v
18
1
18
356v
3
5
15
31.8
477
Total ................................................
........................
........................
........................
........................
..........................
3,339
ehiers on DSK2VPTVN1PROD with NOTICES
1 There
159
Total hours
2,862
are no capital costs or operating and maintenance costs associated with this collection of information.
ANADA paperwork burden (section
512(b)(2) of the FD&C Act). Over the
past 5 fiscal years, from October 2007
through September 2012, FDA has
received an average of 21 ANADAs per
year. FDA estimates that preparing the
paperwork required under 21 U.S.C.
360b(n)(1) to be contained in an
ANADA, whether all of the information
is submitted with the ANADA or the
applicant submits information for
phased review followed by an
Administrative ANADA that references
that information, will take
approximately 159 hours. (FDA is
estimating that each ANADA that uses
VerDate Mar<15>2010
13:45 Aug 23, 2013
Jkt 229001
the phased review process will have
approximately five phased reviews per
application. Therefore, assuming that
three respondents will take advantage of
the phased review option per year and
an average of five phased reviews are
submitted per application, times 31.8
hours per phased review, equals 477
total hours per year or 159 hours per
application.)
Although over the last 5 fiscal years
all sponsors chose to submit traditional
ANADAs, some sponsors did indicate
an interest in using the phased review
option in the future. FDA believes that,
with time, more and more sponsors will
PO 00000
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Fmt 4703
Sfmt 4703
take advantage of the phased review
option as it provides greater flexibility
and estimates that there will be three
respondents for the phased review
option. FDA also estimates that
sponsors of ANADAs take
approximately 25 percent less time to
put together the information to support
an ANADA than a new animal drug
application (NADA) because they only
need to provide evidence of
bioequivalence and not the data
required in a NADA to support a full
demonstration of safety and
effectiveness.
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52771-52772]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20643]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-13RE]
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
20503 or by fax to (202) 395-5806. Written comments should be received
within 30 days of this notice.
Proposed Project
Public Health Systems, Mental Health and Community Recovery
Project--New--Office of Public Health Preparedness and Response,
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This project stems from, and aligns with, publication of the Office
of Public Health Preparedness and Response's (OPHPR) ``National
Strategic Plan for Public Health Preparedness and Response'' which
provides overall direction for Centers for Disease Control and
Prevention's (CDC) preparedness and response portfolio, including
programmatic direction across OPHPR's four divisions. The focus of this
project is to generate findings useful for future preparedness planning
and response in order to develop strategies and interventions aimed at
mitigating the impact of adverse events. In April 2011, one of the
largest tornado outbreaks ever recorded, a ``Super Outbreak,'' occurred
in the southeastern United States, resulting in more than 300 deaths
and an estimated $10 billion in damages. This large-scale multistate
tragedy offers a unique opportunity to study how communities with
similar cultural and geographic features yet different public health
and mental health emergency response systems could provide access to
care around the same crisis. The outcomes of these efforts can inform
the field of what effect these differences had on the recovery patterns
of each of these communities. By doing so, we can begin to elucidate
best practices for robust community preparedness and recovery with
attention to types of services that most effectively promote the
natural resilience of survivors. Two primary research questions will
guide the proposed study:
1. How did the Alabama and Mississippi State and local public
health and mental health (PH/MH) systems prepare for, respond to, and
support recovery after the April 2011 tornados?
2. To what extent have these communities recovered and what is the
overall health and quality of life of individuals affected by these
events?
CDC requests OMB approval to collect information for two years.
To address these questions, CDC, in collaboration with ICF
International, will conduct a mixed method evaluation utilizing key
informant interviews of public health and mental health agency staff
and other leaders from the community and household survey data in each
of the four regions in Mississippi and Alabama to assess community
recovery. Specifically, the study design includes two main components
(qualitative and quantitative) designed to comprehensively examine the
PH/MH system response to and community recovery and resilience from
disasters.
The total estimated burden for the 98 one-time qualitative
interviews for public health/mental health professionals and community
leaders is 98 hours (98 respondents x 1 hour/response). Interviews will
be conducted during an in-person site-visit to the region to reduce
travel and time burdens on the respondents. Respondents unable to
participate during the site visit may participate via telephone. In
addition, the total estimated burden for the quantitative computer-
assisted interviews are based on 1,313 screener respondents and 860
survey respondents in each of the four tornado effected regions; the
screener will take approximately 2 minutes to complete and the survey
will take approximately 25 minutes to complete.(Study Screener: 4
counties x 1,313 study screeners = 5,252 participants screened; 5,252
participants x 2/60 minutes = 175 hours; Household Survey for General
Public: 4 counties x 860 respondents = 3,440 respondents; 3,440
respondents x 25/60 minutes = 1,433 hours).
There are no costs to respondents other than their time.
The total estimated annual burden hours are 1,706.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Mental Health/Public Health Agency Key Informant Interview 53 1 1
Staff. Guide--PH/MH Agency
Staff & Key Informant
Interview Guide--
Consent Form.
Community Organization Leaders........ Key Informant Interview 45 1 1
Guide--Community
Organization
Respondents & Key
Informant Interview
Guide--Consent Form.
General public from disaster affected Household Survey for 3,440 1 25/60
communities. General Public and
Consent.
General public from disaster affected Household Survey for 5,252 1 2/60
communities. General Public--Study
Screener.
----------------------------------------------------------------------------------------------------------------
[[Page 52772]]
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. 2013-20643 Filed 8-23-13; 8:45 am]
BILLING CODE 4163-18-P
