Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices 17765 

Elimination of Tuberculosis, 

Department of Health and Human 

Services, 1600 Clifton Road NE., 

Mailstop E–10, Atlanta, Georgia 30333, 

telephone 404/639–8000 or fax 404/

639–8600. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–07541 Filed 4–1–15; 8:45 am] 

BILLING CODE CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0045] 

Abuse-Deterrent Opioids—Evaluation 

and Labeling; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Abuse-Deterrent Opioids— 

Evaluation and Labeling’’. This 

guidance explains FDA’s current 

thinking about the studies that should 

be conducted to demonstrate that a 

given formulation has abuse-deterrent 

properties. This guidance also makes 

recommendations about how those 

studies should be performed and 

evaluated, and discusses how to 

describe those studies and their 

implications in product labeling. It is 

intended to assist sponsors who wish to 

develop opioid drug products with 

potentially abuse-deterrent properties 

and is not intended to apply to products 

that are not opioids or opioid products 

that do not have the potential for abuse. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of this 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 guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Brutrinia D. Cain, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–4633, Brutrinia.Cain@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘AbuseDeterrent Opioids—Evaluation and 

Labeling.’’ Prescription opioid products 

are an important component of modern 

pain management. However, abuse and 

misuse of these products have created a 

serious and growing public health 

problem. One potentially important step 

towards the goal of creating safer opioid 

analgesics has been the development of 

opioids that are formulated with some 

properties intended to deter abuse. FDA 

considers development of these 

products a high public health priority. 

The guidance is intended to provide 

industry with a framework for 

evaluating and labeling abuse-deterrent 

opioid products. The guidance 

discusses how the potentially abusedeterrent properties of an opioid 

analgesic formulated to deter abuse 

should be studied, specifically 

addressing in vitro studies, 

pharmacokinetic studies, clinical abuse 

potential studies, and postmarket 

studies. The guidance also describes the 

types of information that may be 

suitable for inclusion in labeling. 

Providing a clear framework for the 

evaluation and labeling of the abusedeterrent properties of opioid analgesics 

intended to deter abuse should help to 

incentivize the development of safer, 

less abusable opioid analgesics, and 

should also facilitate the dissemination 

of fair and accurate information 

regarding such products. 

In the Federal Register of January 14, 

2013 (78 FR 2676), FDA announced the 

availability of a draft version of this 

guidance and provided interested 

parties an opportunity to submit 

comments. The Agency has carefully 

reviewed and considered the comments 

it received in developing this final 

version of the guidance. The Agency has 

made revisions to the guidance as it 

deemed appropriate. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on the evaluation and 

labeling of abuse-deterrent opioids. 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. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://www.

regulations.gov. 

Dated: March 27, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07562 Filed 4–1–15; 8:45 am] 

BILLING CODE CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[OMB Control Number 1615–0005] 

Agency Information Collection 

Activities: Application for Family Unity 

Benefits, Form I–817; Revision of a 

Currently Approved Collection 

AGENCY: U.S. Citizenship and 

Immigration Services (USCIS), 

Department of Homeland Security 

(DHS). 

ACTION: 60-Day notice. 

SUMMARY: DHS, USCIS invites the 

general public and other Federal 

agencies to comment upon this 

proposed revision of a currently 


tkelley on DSK3SPTVN1PROD with NOTICES
17766 Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices 

approved collection of information. In 

accordance with the Paperwork 

Reduction Act (PRA) of 1995, the 

information collection notice is 

published in the Federal Register to 

obtain comments regarding the nature of 

the information collection, the 

categories of respondents, the estimated 

burden (i.e. the time, effort, and 

resources used by the respondents to 

respond), the estimated cost to the 

respondent, and the actual information 

collection instruments. 

DATES: Comments are encouraged and 

will be accepted for 60 days until June 

1, 2015. 

ADDRESSES: All submissions received 

must include the OMB Control Number 

1615–0005 in the subject box, the 

agency name and Docket ID USCIS– 

2009–0021. To avoid duplicate 

submissions, please use only one of the 

following methods to submit comments: 

(1) Online. Submit comments via the 

Federal eRulemaking Portal Web site at 

www.regulations.gov under e-Docket ID 

number USCIS–2009–0021; 

(2) Email. Submit comments to 

USCISFRComment@uscis.dhs.gov; 

(3) Mail. Submit written comments to 

DHS, USCIS, Office of Policy and 

Strategy, Chief, Regulatory Coordination 

Division, 20 Massachusetts Avenue 

NW., Washington, DC 20529–2140. 

FOR FURTHER INFORMATION CONTACT: 

USCIS, Office of Policy and Strategy, 

Regulatory Coordination Division, Laura 

Dawkins, Chief, 20 Massachusetts 

Avenue NW., Washington, DC 20529– 

2140, telephone number 202–272–8377 

(comments are not accepted via 

telephone message). Please note contact 

information provided here is solely for 

questions regarding this notice. It is not 

for individual case status inquiries. 

Applicants seeking information about 

the status of their individual cases can 

check Case Status Online, available at 

the USCIS Web site at http://

www.uscis.gov, or call the USCIS 

National Customer Service Center at 

800–375–5283 (TTY 800–767–1833). 

SUPPLEMENTARY INFORMATION: 

Comments: You may access the 

information collection instrument with 

instructions, or additional information 

by visiting the Federal eRulemaking 

Portal site at: http://

www.regulations.gov and enter USCIS– 

2009–0021 in the search box. Regardless 

of the method used for submitting 

comments or material, all submissions 

will be posted, without change, to the 

Federal eRulemaking Portal at http://

www.regulations.gov, and will include 

any personal information you provide. 

Therefore, submitting this information 

makes it public. You may wish to 

consider limiting the amount of 

personal information that you provide 

in any voluntary submission you make 

to DHS. DHS may withhold information 

provided in comments from public 

viewing that it determines may impact 

the privacy of an individual or is 

offensive. For additional information, 

please read the Privacy Act notice that 

is available via the link in the footer of 

http://www.regulations.gov. 

Written comments and suggestions 

from the public and affected agencies 

should address one or more of the 

following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Revision of a Currently Approved 

Collection. 

(2) Title of the Form/Collection: 

Application for Family Unity Benefits. 

(3) Agency form number, if any, and 

the applicable component of the DHS 

sponsoring the collection: I–817; USCIS. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

households: The information collected 

will be used to determine whether the 

applicant meets the eligibility 

requirements for benefits under 8 CFR 

236.14 and 245a.33. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: The estimated total number of 

respondents for the information 

collection I–817 is approximately 2,557 

and the estimated hour burden per 

response is 2 hours per response; and 

the estimated number of respondents 

providing biometrics is 2,557 and the 

estimated hour burden per response is 

1.17 hours. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: The total estimated annual 

hour burden associated with this 

collection is 8,106 hours. 

Dated: March 27, 2015. 

Laura Dawkins, 

Chief, Regulatory Coordination Division, 

Office of Policy and Strategy, U.S. Citizenship 

and Immigration Services, Department of 

Homeland Security. 

[FR Doc. 2015–07506 Filed 4–1–15; 8:45 am] 

BILLING CODE 9111–97–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–5843–N–04] 

Implementation of the Privacy Act of 

1974, as Amended; New System of 

Records, the Housing Search Process 

for Racial and Ethnic Minorities 

Evaluation Data Files 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: New system of records. 

SUMMARY: The Department’s Office of 

Policy Development and Research 

(PD&R) is proposing to create a new 

system of records, the ‘‘Housing Search 

Process for Racial and Ethnic Minorities 

Evaluation Data Files.’’ The 

Department’s Office of PD&R is 

responsible for maintaining current 

information on housing needs, market 

conditions and existing programs, as 

well as conducting research on priority 

housing and community development 

issues. 

The principal purpose of the 

evaluation of the Housing Search 

Process for Racial and Ethnic Minorities 

is to: Help guide the Department’s 

research toward a more comprehensive 

understanding of the rental housing 

search processes for individual 

households; Make informed decisions 

on the development of more effective 

enforcement strategies to combat 

discriminatory practices; Identify ways 

to expand housing opportunities for 

racial and ethnic minorities. Further, 

HUD’s Office of Housing Counseling for 

rental housing assistance, and the Office 

of Housing Choice Vouchers, among 

others will leverage the outcome study 

results for policy development and best 

practices aimed to ‘‘build inclusive and 

sustainable communities free from 

discrimination’’, and to identify and 

correct barriers that racial and ethnic 

minorities may experiences in the rental 

housing market. Finally, this study will 

allow the Department to leverage its 

own regular data collection efforts, like 


tkelley on DSK3SPTVN1PROD with NOTICES