Published 60 Day FRN

Attachment 2a:
Published 60-Day Federal Register Notice
Division of Violence Prevention
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention

20114

Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Notices

Dated: March 28, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–07742 Filed 4–2–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–13–13PQ]

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 Ron Otten, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to [email protected].
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.

mstockstill on DSK4VPTVN1PROD with NOTICES

Proposed Project
DELTA FOCUS Program Evaluation—
New—National Center for Injury
Prevention and Control (NCIPC),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Intimate Partner Violence (IPV) is a
serious, preventable public health

VerDate Mar<15>2010

17:13 Apr 02, 2013

Jkt 229001

problem that affects millions of
Americans and results in serious
consequences for victims, families, and
communities. IPV occurs between two
people in a close relationship. The term
‘‘intimate partner’’ describes physical,
sexual, or psychological harm by a
current or former partner or spouse. IPV
can impact health in many ways,
including long-term health problems,
emotional impacts, and links to negative
health behaviors. IPV exists along a
continuum from a single episode of
violence to ongoing battering; many
victims do not report IPV to police,
friends, or family.
Primary prevention means stopping
IPV before it occurs. In 2002, authorized
by the Family Violence Prevention
Services Act (FVPSA), CDC developed
the Domestic Violence Prevention
Enhancements and Leadership Through
Alliances (DELTA) Program, with a
focus on the primary prevention of IPV.
Since that time, The DELTA Program
has funded state domestic violence
coalitions (SDVCs) to engage in
statewide primary prevention efforts
and to provide training, technical
assistance, and financial support to
local communities for local primary
prevention efforts. DELTA FOCUS
(Domestic Violence Prevention
Enhancement and Leadership through
Alliances, Focusing on Outcomes for
Communities United with States) builds
on that history by providing focused
funding to states and communities for
intensive implementation and
evaluation of IPV primary prevention
strategies that address the structural
determinants of health at the societal
and community levels of the socialecological model (SEM).
The purpose of the DELTA FOCUS
program is to promote the prevention of
IPV through the implementation and
evaluation of strategies that create a
foundation for the development of
practice-based evidence. By
emphasizing primary prevention, this
program will support comprehensive
and coordinated approaches to IPV
prevention. Each SDVC is required to
identify and fund one to two wellorganized, broad-based, active local
coalitions (referred to as coordinated
community responses or CCRs) that are
already engaging in, or are at capacity to
engage in, IPV primary prevention
strategies affecting the structural
determinants of health at the societal
and/or community levels of the SEM.
SDVCs must facilitate and support local-

PO 00000

Frm 00028

Fmt 4703

Sfmt 4703

level implementation and hire
empowerment evaluators to support the
evaluation of IPV prevention strategies
by the CCRs. SDVCs must also
implement and with their
empowerment evaluators, evaluate
state-level IPV prevention strategies.
CDC seeks OMB approval to collect
information electronically from
awardees, their CCRs and their
empowerment evaluators. Information
will be collected using the DELTA
FOCUS Program Evaluation Survey
(referred to as DF Survey). The DF
survey will collect information about
SDVCs satisfaction with CDC efforts to
support them; process, program and
strategy implementation factors that
affect their ability to meet the
requirements of the Funding
Opportunity Announcement (FOA);
prevention knowledge and use of the
public health approach; and
sustainability of prevention activities
and successes.
Information collected through the DF
Survey will be used to guide program
improvements by CDC in the national
DELTA FOCUS program
implementation and program
improvements by SDVCs in
implementation of the program within
their state. Specifically the data
collection will allow the federal
government to assess: a) opportunities
and barriers to implementing the
DELTA FOCUS program at the state and
local levels, b) benefits and challenges
of focusing on prevention strategies at
the societal and community levels, and
c) what data informed program
improvements are needed. Not
collecting this data could result in
inappropriate implementation at the
national, state, and local levels. Thus,
this data collection is an essential
program evaluation activity.
The DF Survey will be completed by
10 SDVC executive directors, 10 SDVC
project coordinators, 19 CCR project
coordinators, and 10 SDVC
empowerment evaluators and take a
maximum of 1 hour to complete. We
expect for each SDVC there will be four
web-based surveys completed in the
first year (2013) of awardee activity.
CDC will analyze, interpret, translate,
and disseminate the survey findings in
years two and three of the information
collection request. The total estimated
annualized burden for the proposed 10
awardees is 44 hours. There are no costs
to respondents other than their time.

E:\FR\FM\03APN1.SGM

03APN1

20115

Federal Register / Vol. 78, No. 64 / Wednesday, April 3, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN TO RESPONDENTS

Total burden
(in hours)

Form name

State Domestic Violence Coalition Executive Director.
State Domestic Violence Coalition Project Coordinator.
Coordinated Community Response Project Coordinator.
State Domestic Violence Coalition Empowerment Evaluator.

DELTA FOCUS Survey ........

10

1

1

10

DELTA FOCUS Survey .......

10

1

1

10

DELTA FOCUS Survey .......

19

1

1

19

DELTA FOCUS Survey .......

10

1

.50

5

Total ...............................

..............................................

..............................

..............................

..............................

44

Dated: March 28, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–07741 Filed 4–2–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1203]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request: Information To
Accompany Humanitarian Device
Exemption Applications and Annual
Distribution Number Reporting
Requirements
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 May 3,
2013.
SUMMARY:

To ensure that comments on
the information collection are received,
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
[email protected]. All
comments should be identified with the
OMB control number 0910–0661. Also
include the FDA docket number found

ADDRESSES:

mstockstill on DSK4VPTVN1PROD with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Type of respondents

VerDate Mar<15>2010

17:13 Apr 02, 2013

Jkt 229001

in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:

Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, [email protected].
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.
Information To Accompany
Humanitarian Device Exemption
Applications and Annual Distribution
Number Reporting Requirements
(Formerly: Humanitarian Device
Exemption Holders, Institutional
Review Boards, Clinical Investigators
and FDA Staff Humanitarian Device
Exemption Regulation: Questions and
Answers)—(OMB Control Number
0910–0661)—Revision
Under section 520(m) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360j(m)), FDA is
authorized to exempt a humanitarian
use device (HUD) from the effectiveness
requirements in sections 514 and 515 of
the FD&C Act (21 U.S.C. 360d and 360e)
provided that the device: (1) Is used to
treat or diagnose a disease or condition
that affects fewer than 4,000 individuals
in the United States; (2) would not be
available to a person with such a disease
or condition unless the exemption is
granted, and there is no comparable
device, other than another HUD
approved under this exemption,
available to treat or diagnose the disease
or condition; (3) the device will not
expose patients to an unreasonable or
significant risk of illness or injury; and
(4) the probable benefit to health from
using the device outweighs the risk of
injury or illness from its use, taking into
account the probable risks and benefits

PO 00000

Frm 00029

Fmt 4703

Sfmt 4703

of currently available devices or
alternative forms of treatment.
HUDs approved under an HDE cannot
be sold for an amount that exceeds the
costs of research and development,
fabrication, and distribution of the
device (i.e., for profit), except in narrow
circumstances. Section 613 of the Food
and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144), signed into law on July 9, 2012,
amended section 520(m) of the FD&C
Act. Under section 520(m)(6)(A)(i) of the
FD&C Act, as amended by FDASIA, a
HUD approved under an HDE is eligible
to be sold for profit if the device meets
the following criteria:
• The device is intended for the
treatment or diagnosis of a disease or
condition that occurs in pediatric
patients or in a pediatric subpopulation,
and such device is labeled for use in
pediatric patients or in a pediatric
subpopulation in which the disease or
condition occurs; or
• the device is intended for the
treatment or diagnosis of a disease or
condition that does not occur in
pediatric patients or that occurs in
pediatric patients in such numbers that
the development of the device for such
patients is impossible, highly
impracticable, or unsafe.
Section 520(m)(6)(A)(ii) of the FD&C
Act, as amended by FDASIA, provides
that the Secretary of Health and Human
Services (the Secretary) will assign an
ADN for devices that meet the eligibility
criteria to be permitted to be sold for
profit. The ADN is defined as the
number of devices ‘‘reasonably needed
to treat, diagnose, or cure a population
of 4,000 individuals in the United
States,’’ and therefore shall be based on
the following information in a HDE
application: The number of devices
reasonably necessary to treat such
individuals.
Section 520(m)(6)(A)(iii) of the FD&C
Act (http://www.fda.gov/

E:\FR\FM\03APN1.SGM

03APN1