Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41269 

DATES: 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: 

OIRA_submission@omb.eop.gov. 

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 

Paperwork@cms.hhs.gov. 

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 

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] 

BILLING CODE 4120–01–P 

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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41270 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 

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 

comments and suggestions submitted 

within 60 days of this publication. 

Mary Jones, 

ACF/OPRE Reports Clearance Officer. 

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

BILLING CODE 4184–72–P 

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. 

SUMMARY: 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 

comments on the draft revised guidance 

by October 30, 2017. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

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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