17764 Federal Register / Vol. 80, No. 63 / Thursday, April 2, 2015 / Notices 

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: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Generic 

Clearance for Questionnaire Testing and 

Methodological Research for the 

Medicare Current Beneficiary Survey 

(MCBS); Use: The purpose of this OMB 

clearance package is to clear a Generic 

Clearance to support an effort to 

evaluate the operations and content of 

the Medicare Current Beneficiary 

Survey (MCBS). The MCBS is a 

continuous, multipurpose survey of a 

nationally representative sample of 

aged, disabled, and institutionalized 

Medicare beneficiaries. The MCBS, 

which is sponsored by the Centers for 

Medicare & Medicaid Services (CMS), is 

the only comprehensive source of 

information on the health status, health 

care use and expenditures, health 

insurance coverage, and socioeconomic 

and demographic characteristics of the 

entire spectrum of Medicare 

beneficiaries. 

The core of the MCBS is a series of 

interviews with a stratified random 

sample of the Medicare population, 

including aged and disabled enrollees, 

residing in the community or in 

institutions. Questions are asked about 

enrollees’ patterns of health care use, 

charges, insurance coverage, and 

payments over time. Respondents are 

asked about their sources of health care 

coverage and payment, their 

demographic characteristics, their 

health and work history, and their 

family living circumstances. In addition 

to collecting information through the 

core questionnaire, the MCBS collects 

information on special topics through 

supplements. For example, questions 

are asked about enrollees’ income and 

assets, access to health care, health and 

functional status and satisfaction with 

care. Special supplements also focus on 

emerging trends in health care. Form 

Number: CMS–10549 (OMB control 

number 0938–New); Frequency: 

Occasionally; Affected Public: 

Individuals or Households; Number of 

Respondents: 1,500; Total Annual 

Responses: 1,500; Total Annual Hours: 

1,117. (For policy questions regarding 

this collection contact William Long at 

410–786–7927.) 

Dated: March 26, 2015. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–07322 Filed 4–1–15; 8:45 am] 

BILLING CODE CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Notice of Availability: Test Tools and 

Test Procedures Approved by the 

National Coordinator for the ONC HIT 

Certification Program 

AGENCY: Office of the National 

Coordinator for Health Information 

Technology (ONC), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

availability of test tools and test 

procedures approved by the National 

Coordinator for Health Information 

Technology (the National Coordinator) 

for the testing of EHR technology to two 

2014 Edition Release 2 EHR certification 

criteria under the ONC HIT Certification 

Program. The approved test tools and 

test procedures for the ‘‘optional— 

transitions of care’’ certification 

criterion (§ 170.314(b)(8)) and the 

revised ‘‘view, download, and transmit 

to 3rd party’’ certification criterion 

(§ 170.314(e)(1)) are identified on the 

ONC Web site at: http://healthit.gov/

policy-researchers-implementers/

testing-and-test-methods. The test tools 

and test procedures for all the other 

2014 Edition Release 2 EHR certification 

criteria were previously approved by the 

National Coordinator. 

FOR FURTHER INFORMATION CONTACT: 

Alicia Morton, Director, Office of 

Certification, Office of the National 

Coordinator for Health Information 

Technology, 202–549–7851. 

SUPPLEMENTARY INFORMATION: On 

January 7, 2011, the Department of 

Health and Human Services issued a 

final rule establishing a permanent 

certification program for the purposes of 

testing and certifying health information 

technology (‘‘Establishment of the 

Permanent Certification Program for 

Health Information Technology,’’ 76 FR 

1262) (Permanent Certification Program 

final rule). The permanent certification 

program was renamed the ‘‘ONC HIT 

Certification Program’’ in a final rule 

published on September 4, 2012 (77 FR 

54163) (‘‘2014 Edition EHR Certification 

Criteria final rule’’). In the preamble of 

the Permanent Certification Program 

final rule, we stated that when the 

National Coordinator had approved test 

tools and test procedures for 

certification criteria adopted by the 

Secretary ONC would publish a notice 

of availability in the Federal Register 

and identify the approved test tools and 

test procedures on the ONC Web site. 

In the 2014 Edition Release 2 EHR 

Certification Criteria final rule the 

Secretary adopted additional and 

revised certification criteria as part of 

the 2014 Edition EHR certification 

criteria (79 FR 54430). The National 

Coordinator has approved test tools and 

test procedures for testing EHR 

technology for two 2014 Edition Release 

2 EHR certification criteria under the 

ONC HIT Certification Program. These 

approved test tools and test procedures 

for the ‘‘optional—transitions of care’’ 

certification criterion (§ 170.314(b)(8)) 

and the revised ‘‘view, download, and 

transmit to 3rd party’’ certification 

criterion (§ 170.314(e)(1)) are identified 

on the ONC Web site at: http://

healthit.gov/policy-researchersimplementers/testing-and-test-methods. 

The test tools and test procedures for all 

the other 2014 Edition Release 2 EHR 

certification criteria were previously 

approved by the National Coordinator 

(80 FR 4577) and are available for 

review at the Web site listed above. 

Authority: 42 U.S.C. 300jj–11. 

Dated: March 20, 2015. 

Lisa Lewis, 

Acting National Coordinator for Health 

Information Technology 

[FR Doc. 2015–07572 Filed 4–1–15; 8:45 am] 

BILLING CODE CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Council for the Elimination of 

Tuberculosis: Notice of Charter 

Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the 

Advisory Council for the Elimination of 

Tuberculosis, Department of Health and 

Human Services, has been renewed for 

a 2-year period through March 15, 2017. 

For information, contact Hazel Dean, 

Sc.D., M.P.H., Designated Federal 

Officer, Advisory Council for the 


tkelley on DSK3SPTVN1PROD with NOTICES
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