35936 Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 

(3) What are the key functions of the 

B Reader certification and recertification examinations grading 

system, and how should the 

examinations be graded to accomplish 

those functions? Should the general 

approach currently used for grading 1 2

be changed and if yes, how and why? 

(4) Should NIOSH consider 

alternative approaches to maintenance 

of B Reader certification besides 

recertification examinations every 4 

years? If so, what alternative approaches 

would be both effective and desirable? 

(5) NIOSH seeks to obtain materials, 

including published and unpublished 

reports and research findings that will 

help to answer these questions. NIOSH 

encourages respondents to provide these 

materials. 

References 

1. Morgan RH [1979].Proficiency 

Examination of Physicians for Classifying 

Pneumoconiosis Chest Films. AJR 132: 

803–808. 

2. Wagner GR, Attfield MD, Kennedy RD, 

Parker JE [1992]. The NIOSH B Reader 

Certification Program-An Update Report. J 

Occup Med 34(9):879–84. 

Dated June 7, 2013. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2013–14147 Filed 6–13–13; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 78 FR 30307–30312, 

dated May 22, 2013) is amended to 

reorganize the Office of the Associate 

Director for Science, Office of the 

Director, Centers for Disease Control 

and Prevention, and to revise the 

functional statement for the Office of 

Scientific Integrity, Office of the 

Director, National Center for 

Immunization and Respiratory Diseases. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: 

Delete in its entirety the functional 

statement for the Office of the Director 

(CAS1), Office of the Associate Director 

for Science (CAS), and insert the 

following: 

Office of the Director (CAS1). (1) 

Directs, manages, and coordinates the 

activities of the OADS; (2) develops 

goals and objectives, provides 

leadership, policy formation, scientific 

oversight, and guidance in program 

planning and development; and (3) 

oversees functions of Office of Science 

Quality, Office of Scientific Integrity, 

Office of Technology and Innovation, 

and Special Projects Activity. 

After the title and function statement 

for the Office of Scientific Integrity 

(CASJ), Office of the Associate Director 

for Science (CAS), insert the following: 

Office of Technology and Innovation 

(CASK). (1) Promotes and facilitates the 

development of technology and 

innovation throughout the spectrum of 

scientific discovery; (2) provides 

leadership and expertise to promote and 

effect the timely transfer of knowledge 

and technology for development of 

products and processes that improve 

public health; (3) manages CDC’s 

intellectual property (e.g., patents, 

trademarks, copyrights) and promotes 

the transfer of new technology from 

CDC research to the private sector; (4) 

leads, develops, coordinates, and 

manages policies and/or activities that 

assure CDC intellectual property 

transfer, scientific training and technical 

assistance; (5) champions and facilitates 

innovation, collaborations and 

technology transfers among federal 

scientists, laboratories, academia and 

industry; (6) provides leadership and 

oversight for innovation activities that 

have the potential to transform the way 

that CDC and the private sector improve 

the public’s health; (7) provides 

consultation and advice to the CDC 

Office of the Director, Centers/Institute/ 

Offices, and programs related to 

technology transfer and innovation; and 

(8) maintains regular, open, and 

responsive communication with the 

CDC science community and other key 

partners including CDC Office of 

General Council, National Institute of 

Health, Department of Health and 

Human Services and United States 

Patent and Trademark Office. 

Delete in its entirety the functional 

statement for the Office of Laboratory 

Science (CVG14), Office of the Director 

(CVG1), National Center for 

Immunization and Respiratory Diseases 

(CVG), and insert the following: 

Office of Laboratory Science (CVG14). 

(1) Provides leadership, expertise and 

service in laboratory science; (2) 

represents NCIRD’s interests in crosscutting laboratory services in OID which 

include, but are not limited to, 

laboratory information systems, quality 

management systems and 

bioinformatics; (3) ensures a safe 

working environment in NCIRD 

laboratories; and (4) collaborates 

effectively with other centers and offices 

in carrying out its functions. 

Dated: June 6, 2013. 

Sherri A. Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2013–14165 Filed 6–13–13; 8:45 am] 

BILLING CODE 4163–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers CMS–10482] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

any of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments must be received by 

August 13, 2013: 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). To be 

assured consideration, comments and 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices 35937 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Numberlll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

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: Call 

the Reports Clearance Office at (410) 

786–1326. 

SUPPLEMENTARY INFORMATION: 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10482 Evaluation of the 

Physician Quality Reporting System 

(PQRS) and Electronic Prescribing 

(eRx) Incentive Program 

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 

requires federal agencies to publish a 

60-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. 

Information Collection 

1. Type of Information Collection 

Request: New Collection (Request for a 

new OMB control number); Title of 

Information Collection: Evaluation of 

the Physician Quality Reporting System 

(PQRS) and Electronic Prescribing (eRx) 

Incentive Program; Use: The Physician 

Quality Reporting System (PQRS) was 

first implemented in 2007 as an 

incentive for voluntary reporting of 

quality measures in accordance with a 

section of the Tax Relief and Health 

Care Act of 2006. The PQRS was further 

extended and enhanced by legislation 

such as the Medicare, Medicaid, and 

State Children’s Health Insurance 

Program (SCHIP) Extension Act of 2007 

(MMSEA) and the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA). A 

number of changes have been made to 

the PQRS, including group measures, 

the group reporting option, and 

additional measures. The PQRS was 

extended further with the enactment of 

MMSEA. The MMSEA provided 

professionals greater flexibility for 

participating in the PQRS for 2008 and 

2009 by authorizing us to establish 

alternative reporting criteria and 

alternative reporting periods for the 

reporting measures groups and for the 

submission of data on the PQRS quality 

measures through clinical data 

registries. The MIPPA, enacted in July 

2008, made the PQRS program 

permanent, further enhanced the PQRS, 

and established a new standalone 

incentive program for successful 

electronic prescribers. 

The eRx Incentive Program, the other 

program being evaluated in this project, 

was first implemented in 2009. The eRx 

is another incentive reporting program 

that uses a combination of incentive 

payments and payment adjustments to 

encourage eRx by eligible professionals. 

The program provides an incentive 

payment to practices with eligible 

professionals who successfully eprescribe for covered Physician Fee 

Schedule services furnished to Medicare 

Part B Fee-For-Service (FFS) 

beneficiaries. Eligible professionals do 

not need to participate in PQRS to 

participate in the eRx Incentive 

Program. 

In support of an evaluation the PQRS 

and the eRx Incentive Program, we will 

conduct three surveys. The surveys will 

include: Medicare beneficiaries, eligible 

professionals, and administrators. This 

evaluation is designed to determine how 

well the PQRS and the eRx Incentive 

Program are contributing to better and 

affordable health care for Medicare 

beneficiaries. The PQRS is a voluntary 

reporting program that provides an 

incentive payment to eligible 

professionals who satisfactorily report 

data on quality measures. We use 

quality measures to promote 

improvements in care delivery and 

payment and to increase transparency. 

The PQRS program rewards eligible 

professionals based on a percentage of 

the estimated Medicare Physician Fee 

Schedule of their allowed Part B charges 

if they meet the defined reporting 

requirements. The PQRS was initially 

referred to as the Physician Quality 

Reporting Initiative (PQRI). Form 

Number: CMS–10482 (OCN: 0938– 

NEW); Frequency: Yearly; Affected 

Public: Individuals and households, 

Business or other for-profit, Not-forprofit institutions; Number of 

Respondents: 6,350; Total Annual 

Responses: 6,350; Total Annual Hours: 

2,545. (For policy questions regarding 

this collection contact Lauren Fuentes at 

410–786–2290. For all other issues call 

410–786–1326.) 

Dated: June 11, 2013. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–14174 Filed 6–13–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0790] 

Food and Drug Administration 

Decisions for Investigational Device 

Exemption Clinical Investigations; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘FDA Decisions for 

Investigational Device Exemption (IDE) 

Clinical Investigations.’’ This guidance 

document was initially issued in draft 

on November 10, 2011, and was 

developed to promote the initiation of 

clinical investigations to evaluate 

medical devices under FDA’s IDE 

regulations. The guidance was also 

intended to provide clarification 

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