Attachment C. 60 Day Notice

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices
Comments on the collection(s) of
information must be received by the
OMB desk officer by September 29,
2017.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, email:
[email protected].
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
[email protected].
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Conditions of
Participation for Critical Access
Hospitals (CAH) and Supporting

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Regulations; Use: At the outset of the
critical access hospital (CAH) program,
the information collection requirements
for all CAHs were addressed together
under the following information
collection request: CMS–R–48 (OCN:
0938–0328). As the CAH program has
grown in both scope of services and the
number of providers, the burden
associated with CAHs with distinct part
units (DPUs) was separated from the
CAHs without DPUs. Section
1820(c)(2)(E)(i) of the Social Security
Act provides that a CAH may establish
and operate a psychiatric or
rehabilitation DPU. Each DPU may
maintain up to10 beds and must comply
with the hospital requirements specified
in 42 CFR Subparts A, B, C, and D of
part 482. Presently, 105 CAHs have
rehabilitation or psychiatric DPUs. The
burden associated with CAHs that have
DPUs continues to be reported under
CMS–R–48, along with the burden for
all 4,890 accredited and non-accredited
hospitals.
The CAH conditions of participation
and accompanying information
collection requirements specified in the
regulations are used by surveyors as a
basis for determining whether a CAH
meets the requirements to participate in
the Medicare program. We, along with
the healthcare industry, believe that the
availability to the facility of the type of
records and general content of records,
which this regulation specifies, is
standard medical practice and is
necessary in order to ensure the wellbeing and safety of patients and
professional treatment accountability.
Form Number: CMS–10239 (OMB
Control number: 0938–1043);
Frequency: Yearly; Affected Public:
Private sector—Business or other forprofit; Number of Respondents: 1,215;
Total Annual Responses: 144,585; Total
Annual Hours: 24,183. (For policy
questions regarding this collection
contact Mary Collins at 410–786–3189.)
Dated: August 24, 2017.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–18275 Filed 8–29–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: National and Tribal Evaluation
of the 2nd Generation of the Health
Profession Opportunity Grants.
OMB No.: 0970–0462.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS) is proposing data
collection activities as part of the Health
Profession Opportunity Grants (HPOG)
to Serve TANF and Other Low Income
Individuals. ACF has developed a multipronged research and evaluation
approach for the HPOG program to
better understand and assess the
activities conducted and their results.
Two rounds of HPOG grants have been
awarded—the first in 2010 (HPOG 1.0)
and the second in 2015 (HPOG 2.0).
There are federal evaluations associated
with each round of grants. HPOG grants
provide funding to government
agencies, community-based
organizations, post-secondary
educational institutions, and tribalaffiliated organizations to provide
education and training services to
Temporary Assistance for Needy
Families (TANF) recipients and other
low-income individuals, including
tribal members. Under HPOG 2.0, ACF
provided grants to five tribal-affiliated
organizations and 27 non-tribal entities.
OMB previously approved data
collection under OMB Control Number
0970–0462 for: The HPOG 2.0 National
and Tribal Evaluation (Approved
August 2015); and the National
Evaluation impact study, the National
Evaluation descriptive study, and the
Tribal Evaluation (All approved June
2017). The proposed data collection
activities described in this Federal
Register Notice will provide data for the
impact and cost benefit studies of the 27
non-tribal grantees participating in the
National Evaluation of HPOG 2.0.
National Evaluation: The National
Evaluation pertains only to the 27 nontribal grantees that received HPOG 2.0
funding. The design for the National
Evaluation features an implementation
study, a systems change analysis, and
cost benefit analysis. In addition, the
National Evaluation is using an
experimental design to measure and
analyze key participant outcomes
including completion of education and
training, receipt of certificates and/or
degrees, earnings, and employment in a

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Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices

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healthcare career. The impact
evaluation will assess the outcomes for
study participants that were offered
HPOG 2.0 training, financial assistance,
and support services, compared to what
their outcomes would have been if they
had not been offered HPOG 2.0 services.
This Notice provides the opportunity
to comment on a proposed new
information collection activity for the
HPOG 2.0 National Evaluation’s impact
study—the HPOG 2.0 Impact Evaluation
first follow-up survey. The first followup survey of both treatment and control
group members will be administered
approximately 15 months after baseline
data collection and random assignment.
The survey will collect data about key
outcomes of interest, including

participants’ tenure and experience in
HPOG programming, certifications and
educational achievements, job
placement, and benefits. These are the
key outcomes of interest for which data
are not otherwise available through
existing data sources. Previously
approved collection activities under
0970–0462 will continue under this new
request for the National Evaluation of
the non-tribal grantees.
In subsequent requests for clearance,
we will submit (1) additional data
collection instruments to support the
descriptive study of the 27 non-tribal
grantees participating in the HPOG 2.0
National Evaluation, including grantee
interview guides and participant
interview guides; and (2) the second

follow-up survey for the HPOG 2.0
National Evaluation impact study. The
second follow-up survey is for
collecting data from both treatment and
control group members at the 27 nontribal grantees, approximately 36
months after baseline data collection
and random assignment. This
submission will also include data
collection necessary for the National
Evaluation’s cost benefit analysis.
Respondents: For the National
Evaluation impact study: HPOG 2.0
study participants at the 27 non-tribal
grantees.
Annual Response Burden Estimates:
(This information collection request is
for 3 years):

Instrument

Total number
of respondents

Annual
number of
respondents

Number of
responses per
respondent

Average
burden hours
per response

Annual burden
hours

HPOG 2.0 National Evaluation: 15-month Follow-up Survey ....................................................................................

10,400

3,467

1

1

3,467

In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families (ACF), Department of Health
and Human Services, is soliciting public
comment on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded in writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments 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)
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.
Consideration will be given to

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comments and suggestions submitted
within 60 days of this publication.

comments on the draft revised guidance
by October 30, 2017.

Mary Jones,
ACF/OPRE Reports Clearance Officer.

ADDRESSES:

[FR Doc. 2017–18410 Filed 8–29–17; 8:45 am]

Electronic Submissions

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]

Product-Specific Guidance for Digoxin;
Draft Revised Guidance for Industry;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
draft revised guidance for industry on
generic digoxin tablets entitled ‘‘Draft
Guidance on Digoxin.’’ The guidance,
once finalized, will provide productspecific recommendations on, among
other things, the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for digoxin tablets.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
revised guidance before it begins work
on the final version of the guidance,
submit either electronic or written
SUMMARY:

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You may submit comments

as follows:
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:

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