Proposed Data Collections Submitted for Public Comment and Recommendations, 54472-54473 [2011-22384]
Download as PDF
<![CDATA[
54472
Federal Register / Vol. 76, No. 170 / Thursday, September 1, 2011 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Form name
Number of
respondents
Number of
responses per
respondent
Avg. burden
per response
(in hrs)
.......................................
........................
........................
........................
Type of respondents
Total ...............................................................
Dated:August 25, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
[FR Doc. 2011–22395 Filed 8–31–11; 8:45 am]
Background and Brief Description
The causes of obesity in the United
States are complex and numerous, and
they occur at social, economic,
environmental, and individual levels.
To address the complex nature of
obesity, the Centers for Disease Control
and Prevention (CDC) encourages states
to adopt public health strategies that
address obesity through environmental
change and policies. In 2009, CDC
issued guidance outlining 24
community-based strategies that can be
implemented to encourage healthy
eating and active living.
CDC plans to collect information
about the effectiveness, in practice, of a
selected group of the 24 recommended
strategies. Information will be collected
through a systematic process for
nominating, screening and assessing
promising program interventions. The
study is designed to highlight local
achievements and identify the most
promising strategies for further
development, evaluation through
rigorous methods, and dissemination for
widespread use. Eligible respondents
include states and jurisdictions that are
funded through CDC’s Nutrition,
Physical Activity and Obesity (NPAO)
cooperative agreement program, states
and jurisdictions that do not currently
have NPAO funding, and other
organizations.
CDC will solicit nominations for preevaluation assessment through on-line
forums (e.g., obesity prevention listservs
supported by CDC and other national
partners, e-mail messages, and an
announcement posted on CDC’s NPAO
Web site). CDC will select programs for
assessment by reviewing completed
program nomination forms, which can
be submitted on-line or in hardcopy
format. The program nomination form is
designed to provide information
enabling an initial assessment of each
candidate program’s suitability for
further evaluation. The topics addressed
in this form include a general program
description, an overview of
organizational capacity, and a summary
of the program’s potential impact, reach
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day–11–11KF]
srobinson on DSK4SPTVN1PROD with NOTICES
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 404–639–5960 or send
comments to Daniel Holcomb, CDC/
ATSDR Reports Clearance Officer, 1600
Clifton Road, MS D–74, Atlanta, GA
30333 or send an e-mail 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
Pre-Evaluation Assessments of
Nutrition, Physical Activity and Obesity
Programs and Policies—New—National
VerDate Mar<15>2010
16:16 Aug 31, 2011
Jkt 223001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Total burden
(in hrs)
40,894
to target population, feasibility,
transportability, acceptability to
stakeholders, and sustainability.
Up to 23 initiatives will be selected
for pre-assessment evaluation over a
two-year period. Selected initiatives
will receive FAQs to help them
understand the process, effort entailed,
and public health benefit. They will also
be asked to provide additional
information supporting coordination of
a site visit and interviews with key
informants.
The primary information collection
involves semi-structured, in-person
interviews with approximately 12 key
informants at each participating site,
including: The lead administrator (1),
program staff (3), evaluator (1), and
community partners and other
stakeholders (7). Community partners
and other stakeholders will be drawn
from both the private sector and the
state, local, and Tribal government
sector. The topics to be addressed
during the site visit interviews include
history and description of the initiative,
stakeholder involvement, evaluation
plans, and funding. Site reviewers will
also collect contextual information
about program implementation through
direct observation, which does not
entail burden to respondents.
Results will be used to identify
promising practices in nutrition,
physical activity, and obesity used by
NPAO grantees and others in the obesity
prevention field; provide feedback and
technical assistance to each initiative’s
developers, implementers and
managers; and assess the evaluation
readiness of obesity prevention
initiatives, thereby encouraging the
judicious use of scarce evaluation
resources.
OMB approval will be requested for
two years. Authority to collect
information is provided to CDC under
Sections 301 (a) and 317 (k) of the
Public Health Service Act. CDC
anticipates reviewing approximately 51
program nomination forms per year. Site
visits will be conducted with an average
of 12 programs per year.
Participation is voluntary. There are
no costs to respondents other than their
time.
E:\FR\FM\01SEN1.SGM
01SEN1
54473
Federal Register / Vol. 76, No. 170 / Thursday, September 1, 2011 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Form name
Nominator ............................
Lead Administrator ..............
Nomination Form ...........................................
Site Visit Availability Calendar .......................
Suggested Interviewees Form .......................
Site Visit Schedule Instructions and Template.
Interview Guide for Lead Administrator .........
Interview Guide for Evaluator ........................
Interview Guide for Program Staff .................
Interview Guide for Community Partners and
Other Stakeholders.
Interview Guide for Community Partners and
Other Stakeholders.
51
12
12
12
1
1
1
1
1
1
1
5
51
12
12
60
12
12
36
48
1
1
1
1
2
1
1
1
24
12
36
48
36
1
1
36
........................................................................
........................
........................
........................
291
Evaluator .............................
Program Staff ......................
State, Local and Tribal
Govt. Sector Partners.
Private Sector Partners .......
Total .............................
Date: August 26, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–22384 Filed 8–31–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–D–1542 (formerly
Docket No. 00D–0892)]
Guidance on Positron Emission
Tomography Drug Applications—
Content and Format for New Drug
Applications and Abbreviated New
Drug Applications; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘PET Drug Applications—
Content and Format for NDAs and
ANDAs.’’ This document is intended to
assist manufacturers of certain positron
emission tomography (PET) drugs in
submitting new drug applications
(NDAs) or abbreviated new drug
applications (ANDAs) in accordance
with the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and FDA
regulations.
SUMMARY:
Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
srobinson on DSK4SPTVN1PROD with NOTICES
DATES:
16:16 Aug 31, 2011
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6164,
Silver Spring, MD 20993, 301–796–
3416.
SUPPLEMENTARY INFORMATION:
I. Background
Notice.
VerDate Mar<15>2010
Number of
respondents
Avg. burden
per response
(in hrs)
Type of
respondents
Jkt 223001
FDA is announcing the availability of
a guidance for industry entitled ‘‘PET
Drug Applications—Content and Format
for NDAs and ANDAs.’’ The guidance is
intended to assist the manufacturers of
certain PET drugs—fludeoxyglucose F
18 injection, ammonia N 13 injection,
and sodium fluoride F 18 injection—in
submitting NDAs and ANDAs in
accordance with the FD&C Act and FDA
regulations. The guidance states that to
continue marketing these PET drugs for
clinical use, manufacturers of these
drugs must submit NDAs of the type
described in section 505(b)(2) of the
FD&C Act (21 U.S.C. 355(b)(2)) or
ANDAs under section 505(j) of the
FD&C Act by December 12, 2011. The
guidance further explains when
submission of a 505(b)(2) application or
ANDA is appropriate and describes the
information that manufacturers of these
PET drugs include in each type of
application.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Total burden
(in hrs)
A revised draft guidance of the same
title was announced in the Federal
Register on February 3, 2011 (76 FR
6143), and Docket No. FDA–2000–D–
1542 was open for comments until April
4, 2011. The February 3, 2011, draft
guidance was a revision of the
document ‘‘Draft Guidance for Industry
on the Content and Format of New Drug
Applications and Abbreviated New
Drug Applications for Certain Positron
Emission Tomography Drug Products,’’
issued on March 10, 2000 (65 FR
13010). The February 3, 2011, revised
guidance was issued as a draft for
comment because FDA’s perspective has
changed significantly since the issuance
of the March 2000 draft guidance. We
received comments from industry and
professional societies. We have carefully
considered and, where appropriate, we
have made corrections, added
information, or clarified the information
in this guidance in response to the
comments or on our own initiative.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the submission of
NDAs and ANDAs for PET drugs. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Notices]
[Pages 54472-54473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22384]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-11-11KF]
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 404-639-5960 or
send comments to Daniel Holcomb, CDC/ATSDR Reports Clearance Officer,
1600 Clifton Road, MS D-74, Atlanta, GA 30333 or send an e-mail 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
Pre-Evaluation Assessments of Nutrition, Physical Activity and
Obesity Programs and Policies--New--National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The causes of obesity in the United States are complex and
numerous, and they occur at social, economic, environmental, and
individual levels. To address the complex nature of obesity, the
Centers for Disease Control and Prevention (CDC) encourages states to
adopt public health strategies that address obesity through
environmental change and policies. In 2009, CDC issued guidance
outlining 24 community-based strategies that can be implemented to
encourage healthy eating and active living.
CDC plans to collect information about the effectiveness, in
practice, of a selected group of the 24 recommended strategies.
Information will be collected through a systematic process for
nominating, screening and assessing promising program interventions.
The study is designed to highlight local achievements and identify the
most promising strategies for further development, evaluation through
rigorous methods, and dissemination for widespread use. Eligible
respondents include states and jurisdictions that are funded through
CDC's Nutrition, Physical Activity and Obesity (NPAO) cooperative
agreement program, states and jurisdictions that do not currently have
NPAO funding, and other organizations.
CDC will solicit nominations for pre-evaluation assessment through
on-line forums (e.g., obesity prevention listservs supported by CDC and
other national partners, e-mail messages, and an announcement posted on
CDC's NPAO Web site). CDC will select programs for assessment by
reviewing completed program nomination forms, which can be submitted
on-line or in hardcopy format. The program nomination form is designed
to provide information enabling an initial assessment of each candidate
program's suitability for further evaluation. The topics addressed in
this form include a general program description, an overview of
organizational capacity, and a summary of the program's potential
impact, reach to target population, feasibility, transportability,
acceptability to stakeholders, and sustainability.
Up to 23 initiatives will be selected for pre-assessment evaluation
over a two-year period. Selected initiatives will receive FAQs to help
them understand the process, effort entailed, and public health
benefit. They will also be asked to provide additional information
supporting coordination of a site visit and interviews with key
informants.
The primary information collection involves semi-structured, in-
person interviews with approximately 12 key informants at each
participating site, including: The lead administrator (1), program
staff (3), evaluator (1), and community partners and other stakeholders
(7). Community partners and other stakeholders will be drawn from both
the private sector and the state, local, and Tribal government sector.
The topics to be addressed during the site visit interviews include
history and description of the initiative, stakeholder involvement,
evaluation plans, and funding. Site reviewers will also collect
contextual information about program implementation through direct
observation, which does not entail burden to respondents.
Results will be used to identify promising practices in nutrition,
physical activity, and obesity used by NPAO grantees and others in the
obesity prevention field; provide feedback and technical assistance to
each initiative's developers, implementers and managers; and assess the
evaluation readiness of obesity prevention initiatives, thereby
encouraging the judicious use of scarce evaluation resources.
OMB approval will be requested for two years. Authority to collect
information is provided to CDC under Sections 301 (a) and 317 (k) of
the Public Health Service Act. CDC anticipates reviewing approximately
51 program nomination forms per year. Site visits will be conducted
with an average of 12 programs per year.
Participation is voluntary. There are no costs to respondents other
than their time.
[[Page 54473]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs) (in hrs)
----------------------------------------------------------------------------------------------------------------
Nominator..................... Nomination Form. 51 1 1 51
Lead Administrator............ Site Visit 12 1 1 12
Availability
Calendar.
Suggested 12 1 1 12
Interviewees
Form.
Site Visit 12 1 5 60
Schedule
Instructions
and Template.
Interview Guide 12 1 2 24
for Lead
Administrator.
Evaluator..................... Interview Guide 12 1 1 12
for Evaluator.
Program Staff................. Interview Guide 36 1 1 36
for Program
Staff.
State, Local and Tribal Govt. Interview Guide 48 1 1 48
Sector Partners. for Community
Partners and
Other
Stakeholders.
Private Sector Partners....... Interview Guide 36 1 1 36
for Community
Partners and
Other
Stakeholders.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 291
----------------------------------------------------------------------------------------------------------------
Date: August 26, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-22384 Filed 8-31-11; 8:45 am]
BILLING CODE 4163-18-P
