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: 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Notices 41271 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2007–D–0369 for ‘‘Draft Guidance on 

Digoxin.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ will be publicly viewable 

at https://www.regulations.gov or at the 

Dockets Management Staff office 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff office, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Submit written requests for single 

copies of the draft revised guidance to 

the Division of Drug Information, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, 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 draft revised guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Xiaoqiu Tang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4730, 

Silver Spring, MD 20993–0002, 301– 

796–5850. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2010 (75 FR 33311), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products,’’ which explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s Web site at https://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

As described in that guidance, FDA 

adopted this process to develop and 

disseminate product-specific guidances 

and to provide a meaningful 

opportunity for the public to consider 

and comment on the guidances. This 

notice announces the availability of a 

draft revised product-specific guidance 

for generic digoxin tablets. 

FDA initially approved new drug 

application (NDA) 020405 for LANOXIN 

(digoxin tablets) in September 1997. In 

May 2008, we issued a final guidance 

for industry on generic digoxin tablets. 

We are now issuing a draft revised 

guidance for industry on generic 

digoxin tablets (‘‘Draft Guidance on 

Digoxin’’). 

In December 2015, Concordia 

Pharmaceuticals submitted a citizen 

petition requesting, among other things, 

that FDA amend the guidance for 

industry on BE recommendations for 

generic digoxin tablets issued in 2008. 

FDA has reviewed the issues raised in 

the citizen petition and is responding to 

the citizen petition (Docket No. FDA– 

2015–P–4566, available at https://

www.regulations.gov). 

This draft revised guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft revised guidance, 

when finalized, will represent the 

current thinking of FDA on the design 

of BE studies to support ANDAs for 

digoxin tablets. It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft revised guidance at 

either https://www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

https://www.regulations.gov. 

Dated: August 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18386 Filed 8–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–E–0624] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; XTORO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for XTORO and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of the U.S. 

Patent and Trademark Office (USPTO), 

Department of Commerce, for the 

extension of a patent which claims that 

human drug product. 

DATES: Anyone with knowledge that any 

of the dates as published (in the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by October 30, 2017. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

February 26, 2018. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

mstockstill on DSK30JT082PROD with NOTICES