0990-0322_Attachment E

0990-0322_Attachment E.pdf

Safe Harbor for Federally Qualified Health Centers Arrangements

0990-0322_Attachment E

OMB: 0990-0322

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Federal Register/Vol. 76, No. 51/Wednesday, March 16, 2011/Notices

14398

through Community-wide Initiatives is
to measure risk behaviors, pregnancies,
and use of contraceptives and family
planning services among youth. The

intercourse during the past 12 months

health services; (3) educating

data collection instrument for the

stakeholders (community leaders,
parents and other constituents) about
relevant evidence-based or evidenceinformed strategies to reduce teen
pregnancy and data on needs and

proposed study is a modified version of

during the past 12 months. To

Components of

these efforts include (1)

implementing evidence-based or
evidence-informed prevention

programs; (2) linking teens to quality

resources in target communities; and (4)
supporting the sustainability of the

community-wide teen pregnancy
prevention effort.

The main objective for the proposed

Teenage
Pregnancy Prevention: Integrating
Services, Programs, and Strategies
Outcome Evaluation of

and (2) the proportion of

youth who

have engaged in sexual intercourse but
have used contraception consistently

determine if the change in this
proportion of interest in the

a recently approved survey (OMB No.

0970-0360 Expiration date 7/31/2013).

intervention community is significantly
different from the control community is

Clearance is being requested to expand

the utilization of a modified version of

one of the most important parameters to

the previously-approved instrument.

be estimated. Power analysis

The Outcome Evaluation of Teenage
Pregnancy Prevention: Integrating
Services, Programs, and. Strategies
through Community-wide Initiatives
will focus on the combined change of
two proportions: (1) The proportion of
youth who have not engaged in sexual

determined that 1,200 surveys per
community will be sufficient to detect
this difference. The precise number of
youth surveyed will depend on the
response rates, and will be between
1,200 and 1,500 per community.

TABLE: ESTIMATED ANNUALIZED BURDEN

Instrument

Type of

Number of

respondent

respondents

Number of
responses per

Average
burden hours

Total annual

respondent

per response

burden hours

1

45/60

6,750

Evaluation of Adolescent Pregnancy Prevention Approaches Household Survey........ ............... .............Youth

Seleda Perryman,
Office oftlie Secretary, Paperwork Reduction
Act Clearance Officer.
(FR Doc. 2011-6088 Filed 3-15-11; 8:45 am)

BILLING CODE 4150-3Q-P

aged 15-19

9,000

use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden. To obtain copies of
the supporting statement and any

written agreement must cover, and
specify the amount of, all good, items,
services, donations, or loans provided
by the individual or entity to the health

related forms for the proposed
e-mail your request, including your

health center must document its basis
for its reasonable expectation that the
arrangement will benefit a medically

address, phone number, OMB number,

underserved population

and OS document identifier, to

(§ 1001.952(w)(3)); and (5) the health

paperwork collections referenced above,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(Document Identifier: OS-D990-D322; 60Day Notice)

Agency Information Collection
Request; GO-Day Public Comment

Request
AGENCY: Office of

the Secretary, HHS.

In compliance with the requirement

Sherette.funncoleman@hhs.gov, or call

the Reports Clearance Office on (202)

to the OS Paperwork Clearance Officer

at the above e-mail address within 60-

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Federally Qualified Health Centers

Office of the Secretary (OS), Department

Arrangements-Extension OMB No.

of this collection of information,

including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency's
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the

center, at reasonable intervals, must
reevaluate the arrangement to ensure

690-6162. Written comments and
that it is expected to continue to benefit
recommendations for the proposed
a medically underserved population,
information collections must be directed and must document the re-evaluation
days.
Proposed Project: Safe Harbor for

of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect

center (§ 1001.952(w)(1)(i)(C)); (4) the

0990-0322-0ffice of Inspector General.

Abstract: The Office of the Inspector
General (OIG), Office of the Secretary
(OS), Department of Health and Human

Services (HHS) is requesting a 3-year
extension of clearance for the data
collection under the anti-kickback
statute, as described below. In order for

an arrangement between a health center
and a donor individual or entity to

contemporaneously (§ 1001.952(w)(4)).

OIG may request to see
documentation kept pursuant to the safe
harbor in order to determine compliance
with the terms of the safe harbor and the
fraud and abuse laws. Compliance with
the safe harbor is voluntary, and no
party is ever required to comply with
the safe harbor.

The safe harbor does not entail a
routine and continuous affirmative

collection of data form the regulated
community. However, health centers
that choose to avail themselves of the

safe harbor must have initial

enjoy safe harbor protection, the

documentation and a re-evaluation of

arrangement (1) Must be set out in
writing (§ 1001.952(w)(1)(i)(A)); (2) the

the arrangement at least annually. The
respondents are businesses and/or other

written agreement must be signed by the

private sector for-profit and not-for-

parties (§ 1001.952(w)(1)(i)(B)); (3) the

profit institutions.

Federal Register/Vol. 76, No. 51/Wednesday, March 16, 2011/Notices

14399

ESTIMATED ANNUALIZED BURDEN TABLE
Number of
responses per

Number of

Type of respondent

respondents

respondent

Health Center ...................................................................................................
1873

Seleda Perryman,
Office of tlie Secretary, Paperwork Reduction
Act Clearance Officer.
(FR Doc. 2011-6087 Filed 3-15-11; 8:45 amJ

BILLING CODE 4152-ll1-P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

(Document Identifier: OS-D990-New; 60Day Notice)

or other forms of information
technology to minimize the information
collection burden.

Request; GO-Day Public Comment

Request
AGENCY: Office of the Secretary, HHS.

In compliance with the requirement
of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency's

functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques

Total burden
hours

hours) per
response

1,873

1

Initiative. OAH is working
collaboratively with the Office of the
Assistant Secretary for Planning and
Evaluation (ASPE), the Centers for

To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections

Disease Control and Prevention (CDC),

and the Administration for Children and

referenced above, e-mail your request,
including your address, phone number,

Families (ACF) on adolescent pregnancy
prevention evaluation activities.
OAH has provided funding to ACF to

OMB number, and OS document
identifier, to

oversee the implementation of the
Evaluation of Adolescent Pregnancy

Sherette.funncoleman@hhs.gov, or call

the Reports Clearance Office on (202)

Agency Information Collection

1

Average
burden (in

Prevention Approaches (PPA). PPA is a
690-6162. Written comments and
random assignment evaluation which
recommendations for the proposed
information collections must be directed will expand available evidence on
effective ways to reduce teen pregnancy.
to the OS Paperwork Clearance Officer
The evaluation will document and test
at the above email address within 60a range of pregnancy prevention
days.
approaches in up to eight program sites.
Proposed Project: Evaluation of
Adolescent Pregnancy Prevention
OAH will jointly oversee with ASPE
Approaches and the Impact Evaluation
the Impact Evaluation of the Teen
of the Teen Pregnancy Prevention
Pregnancy Prevention Program Grantees
Program Grantees: Baseline Data
(TPP Impact Evaluation). The TPP
Collection-OMB No. OS-0990Impact Evaluation will be a random
NEW-Office of Adolescent Health in
assignment evaluation which will
collaboration with the Administration
determine whether program models

for Children and Families and the Office

funded as part of the OAH evidence-

of the Assistant Secretary for Planning

based Teen Pregnancy Prevention
Initiative are effective at preventing teen

and Evaluation.
Abstract: The Office of Adolescent
Health (OAH), Office of the Assistant
Secretary for Health (OASH), U.S.
Department of Health and Human
Services (HHS), is overseeing and

pregnancy, reducing sexually
transmitted infections, and/or impacting

sexual risk behaviors.
The findings from both evaluations
will be of interest to the general public,
to policy-makers, and to organizations
interested in teen pregnancy prevention.

coordinating adolescent pregnancy
prevention evaluation efforts as part of
the Teen Pregnancy Prevention
ESTIMATED ANNUALIZED BURDEN TABLE

Instrument

Average

Annual
number of

Number of
responses per

burden hours

respondents

respondent

per response

Total annual
burden hours

Evaluation of Adolescent Pregnancy Prevention Approaches (PPA)

3,600

30/60

8

8

1,800
64

Baseline Instrument .........................................................................................

School Records, Performance, and Program Participation Data Collection ...

Impact Evaluation of the Teen Pregnancy Prevention Program Grantees (TPP Evaluation)
Baseline Instrument ..........................,...,..,',."..,..,..,",...,.,"",.....',.............,....,.
School Records, Performance and Program Participation Data Collection ..,.
Total for both evaluations ........"....,."...,..,.......................,........................

,....."................

8,080

1

30/60

4,040

12

1

8

96

".."...."............

6,000

,..."..................


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