Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices 9057 

1http://www.abms.org/ 

Maintenance_of_Certification/ABMS_MOC.aspx. 

2http://www.abms.org/Maintenance_of

_Certification/ABMS_MOC.aspx. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3276–NC] 

Medicare Program; Request for 

Information on the Use of Clinical 

Quality Measures (CQMs) Reported 

Under the Physician Quality Reporting 

System (PQRS), the Electronic Health 

Record (EHR) Incentive Program, and 

Other Reporting Programs 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This request for information 

solicits ways in which an eligible 

professional (EP) might use the clinical 

quality measures (CQM) data reported to 

specialty boards, specialty societies, 

regional health care quality 

organizations or other non-federal 

reporting programs to also report under 

the Physician Quality Reporting System 

(PQRS), as well as the Electronic Health 

Record (EHR) Incentive Program. It also 

solicits ways by which the entities 

already collecting CQM data for other 

reporting programs to submit this data 

on behalf of EPs and group practices for 

reporting under the PQRS and the EHR 

Incentive Program. It also requests 

information regarding section 601(b) of 

the American Taxpayer Relief Act of 

2012 which provides for treating an EP 

as satisfactorily reporting data on 

quality measures if the EP is 

satisfactorily participating in a qualified 

clinical data registry. We are requesting 

information from medical specialty 

societies, boards, and registries, other 

third party registry vendors, eligible 

professionals using registries to report 

quality measures, and any other party 

interested in providing information on 

this request for information. 

DATES: The information solicited in this 

notice must be received at the address 

provided below, no later than 5 p.m. 

eastern standard time (e.s.t) April 8, 

2013. 

ADDRESSES: In commenting, refer to file 

code CMS–3276–NC. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

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

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3276–NC, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3276–NC, 

Mail Stop S3–02–01, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Christine Estella, 410–786–0485. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Maintenance of Certification 

Twenty-four member boards of the 

American Board of Medical Specialties 

(ABMS) currently recertify physician 

specialists through the ABMS 

Maintenance of Certification (MOC) 

process.1 The MOC assesses physicians’ 

commitment to lifelong learning 

according to the following six core 

competencies for quality patient care: 

(1) Patient care; (2) medical knowledge; 

(3) practice-based learning and 

improvement; (4) interpersonal and 

communications skills; (5) 

professionalism; and (6) systems-based 

practice. Generally speaking, the MOC 

incorporates these six core 

competencies through a four-part 

process: 

• Part I: Licensure and Professional 

Standing 

• Part II: Lifelong Learning and SelfAssessment 

• Part III: Cognitive Expertise 

• Part IV: Practice Performance 

Assessment 2

Within this four-part process, 

particularly in Part IV, certain member 

boards require the reporting of quality 

measures data using a registry or other 

method associated with a member 

board. More information on the ABMS 

MOC can be found at http://www.abms.

org/Maintenance_of_Certification/

ABMS_MOC.aspx. 

A. The Physician Quality Reporting 

System 

The Physician Quality Reporting 

System (PQRS), as set forth in 

subsections (a), (k) and (m) of section 

1848 of the Social Security Act (the Act) 

and as amended by section 601(b) of the 

American Taxpayer Relief Act of 2012, 

is a quality pay-for-reporting program 

that provides incentive payments 

through 2014, and beginning in 2015, 

payment adjustments to eligible 

professionals (EPs) based on whether or 

not they satisfactorily report data on 

quality measures for covered 

professional services furnished during a 

specified reporting period. The PQRS 

(formerly the Physician Quality 

Reporting Initiative or PQRI) was first 

implemented in 2007 pursuant to the 

Tax Relief and Health Care Act 

(TRHCA) of 2006. Although the PQRS is 

a quality pay-for-reporting program, the 

PQRS is currently used as the basis for 

other CMS programs that measure 

performance. For example, the 

application of the Value-Based Payment 

Modifier in 2015 will be dependent on 

the group practice’s participation in the 

PQRS in 2013. (For additional 

information, see the Calendar Year (CY) 

2013 Medicare Physician Fee Schedule 

(PFS) final rule with comment period 

(77 FR 69306).). 

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9058 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices 

The claims-based reporting 

mechanism was the only reporting 

mechanism available for reporting PQRS 

individual quality measures data under 

the 2007 PQRS. However, the PQRS has 

evolved to offer multiple reporting 

mechanisms, reporting periods, and 

criteria for satisfactory reporting for 

purposes of reporting PQRS quality 

measures data. 

In 2008, the PQRS introduced use of 

the registry-based reporting mechanism. 

The registry-based reporting mechanism 

has proven to be popular among eligible 

professionals, and the number of 

eligible professionals that participate in 

PQRS via registry reporting continues to 

increase. According to the 2010 PQRS 

and e-Prescribing (eRx) Experience 

Report, in 2008, 31 of 32 qualified 

registries submitted data on behalf of 

nearly 12,000 eligible professionals. The 

number of eligible professionals for 

which data was submitted by a registry 

increased to 33,411 in 2009 (from 69 of 

74 qualified registries) and to 56,214 in 

2010 (from 89 of the 96 qualified 

registries). Historically, eligible 

professionals using the registry-based 

reporting mechanism have been more 

successful at meeting the criteria for 

satisfactory reporting of the PQRS data 

than through the claims-based reporting 

mechanism. 

1. Qualification Requirement for 

Registries Submitting PQRS Quality 

Measures Data on Behalf of Eligible 

Professionals and Group Practices 

The PQRS requires every registry that 

wishes to submit data on PQRS quality 

measures on behalf of its eligible 

professionals to become ‘‘qualified’’ 

under the PQRS. The final qualification 

process for registries that wish to 

become qualified to submit PQRS 

quality measures data for 2013 and 

subsequent years can be found in the CY 

2013 Medicare PFS final rule with 

comment period (77 FR 69178). 

Generally, the registry qualification 

process for 2013 and subsequent years 

requires a registry to possess certain 

characteristics and submit a selfnomination statement that indicates that 

the registry has these characteristics and 

of the registry’s intent to submit PQRS 

CQMs data on behalf of its eligible 

professionals for the respective year. 

2. Registries Classified as EHR Data 

Submission Vendors 

In lieu of serving as a registry under 

the PQRS, registries that have access to 

an EHR system may instead serve as an 

EHR data submission vendor. Beginning 

in 2014, a registry acting as an EHR data 

submission vendor must have its EHR 

system certified under the program 

established by the Office of the National 

Coordinator for Health Information 

Technology (ONC) as certified EHR 

technology (CEHRT). (For more 

information see the CY 2013 Medicare 

PFS final rule with comment period (77 

FR 69185).) 

3. PQRS Reporting Options Using the 

Registry-Based Reporting Mechanism 

Since the inception of the registrybased reporting mechanism in 2008, we 

have developed multiple criteria for 

satisfactory reporting for individual 

eligible professionals, and, beginning in 

2013, group practices participating in 

the group practice reporting option 

(GPRO), using the registry-based 

reporting mechanism to report PQRS 

quality measures data. For example, we 

previously have adopted criteria for 

satisfactory reporting using qualified 

registries in which eligible professionals 

or group practices must report data on 

a minimum of three measures or, for 

individual eligible professionals only, 

one measures group, a certain 

percentage or number of cases. Eligible 

professionals or group practices using 

registries that serve as EHR data 

submission vendors may, for 2013, 

either report a minimum of 3 measures 

for at least 80 percent of cases, or use 

the reporting criterion that aligns with 

the EHR Incentive Program. To meet the 

criteria for satisfactory reporting using 

an EHR data submission vendor for the 

2014 PQRS incentive, eligible 

professionals or group practices must 

use the criteria that align with the EHR 

Incentive Program. (For more detailed 

information see the CY 2013 Medicare 

PFS final rule with comment period (77 

FR 69188). 

4. Participation in a Qualified Clinical 

Data Registry 

Section 601(b) of the recently enacted 

American Taxpayer Relief Act of 2012 

amended section 1848(m)(3) of the Act 

to allow eligible professionals to be 

treated as satisfactorily submitting data 

on quality measures for covered 

professional services if the eligible 

professional satisfactorily participates in 

a qualified clinical data registry. For 

2014 and subsequent years, the 

Secretary is required to treat an eligible 

professional as satisfactorily submitting 

data on quality measures under the 

PQRS program if, in lieu of reporting 

PQRS quality measures the eligible 

professional is satisfactorily 

participating, as determined by the 

Secretary, in a qualified clinical data 

registry for the year. 

The Secretary is required to establish 

requirements for an entity to be 

considered a qualified clinical data 

registry, including a requirement that 

the entity provide information, at such 

time and in such manner, as the 

Secretary determines necessary. In 

establishing these requirements, the 

Secretary must consider whether an 

entity: Has mechanisms for 

transparency of data, risk models, and 

measures; requires submission of data 

with respect to multiple payers; 

provides timely performance reports to 

participants at the individual level; and 

supports quality improvement 

initiatives. The pre-rulemaking process 

established in sections 1890 and 1890A 

of the Social Security Act does not 

apply to measures used by a qualified 

registry and registries may use NQFendorsed measures. The Secretary is 

required to establish a process to 

determine whether an entity meets the 

requirements to be a qualified clinical 

data registry. The process can involve a 

determination by the Secretary or the 

Secretary can designate one or more 

independent organizations to make such 

determination, or both approaches can 

be used. 

B. The EHR Incentive Program 

The Health Information Technology 

for Economic and Clinical Health Act 

(the ‘‘HITECH Act’’) is included in the 

American Recovery and Reinvestment 

Act of 2009 (the ‘‘Recovery Act’’). The 

HITECH Act authorized incentive 

payments under Medicare and Medicaid 

for eligible professionals (EPs), eligible 

hospitals, and critical access hospitals 

(CAHs) that adopt, implement, upgrade, 

or demonstrate meaningful use of 

certified EHR technology (CEHRT), and 

beginning in 2015, payment adjustments 

under Medicare for failing to 

demonstrate meaningful use. Certified 

EHR technology may include EHR 

modules that calculate and report 

clinical quality measures data. These 

EHR modules can be part of the EP’s 

CEHRT and used by registries and other 

data submission vendors to report 

clinical quality measures on behalf of 

EPs. 

The EHR Incentive Program will be 

implemented in three stages. For CYs 

2011, 2012, and 2013, EPs are required 

to select and report from a list of 44 

CQMs subject to the reporting criteria 

established for those years. (For more 

information see the July 28, 2010 EHR 

Incentive Program final rule (75 FR 

44409 through 44411) and the 

September 4, 2012 EHR Incentive 

Program Stage 2 final rule (77 FR 

54057).) Beginning in 2014, EPs must 

select and report from a list of 64 CQMs 

that are contained in the 6 domains of 

quality of care established in the 

National Quality Strategy. The six 

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Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices 9059 

3http://www.abms.org/Maintenance_of_

Certification/ABMS_MOC.aspx. 

4http://www.abms.org/Maintenance_of_

Certification/ABMS_MOC.aspx. 

5http://www.sts.org/national-database. 

6http://www.cardiosource.org/Science-AndQuality/Quality-Programs.aspx. 

domains are: (1) Patient and Family 

Engagement; (2) Patient Safety; (3) Care 

Coordination; (4) Population and 

Community Health; (5) Efficient Use of 

Healthcare Resources; and (6) Clinical 

Processes/Effectiveness. In order to 

satisfy the CQM component of the EHR 

Incentive Program beginning in 2014, 

EPs must report nine CQMs covering at 

least three domains. (For more 

information see the September 4, 2012 

EHR Incentive Program Stage 2 final 

rule (77 FR 54058).) 

C. Maintenance of Certification 

Twenty-four member boards of the 

American Board of Medical Specialties 

(ABMS) currently recertify physician 

specialists through the ABMS 

Maintenance of Certification (MOC) 

process.3 The MOC assesses physicians’ 

commitment to lifelong learning 

according to the following six core 

competencies for quality patient care: 

(1) patient care; (2) medical knowledge; 

(3) practice-based learning and 

improvement; (4) interpersonal and 

communications skills; (5) 

professionalism; and (6) systems-based 

practice. Generally speaking, the MOC 

incorporates these six core 

competencies through a four-part 

process: 

• Part I: Licensure and Professional 

Standing 

• Part II: Lifelong Learning and SelfAssessment 

• Part III: Cognitive Expertise 

• Part IV: Practice Performance 

Assessment 4

Within this four-part process, 

particularly in Part IV, certain member 

boards require the reporting of quality 

measures data using a registry or other 

method associated with a member 

board. More information on the ABMS 

MOC can be found at http://www.abms.

org/Maintenance_of_Certification/

ABMS_MOC.aspx. 

D. Other Quality Reporting Programs 

Several quality reporting programs 

exist within private industry as well. 

For example the Society of Thoracic 

Surgeons (STS) established a national 

database in 1989 as an initiative for 

quality improvement and patient safety 

among cardiothoracic surgeons. 5

Similarly, the American College of 

Cardiology (ACC) has developed and 

partnered with other organizations to 

create numerous quality initiatives to 

assist cardiovascular professionals to 

bridge the gap between science and 

practice and to ensure patient access to 

high-quality, appropriate and costeffective care.6

These programs are a small sampling 

of quality reporting programs occurring 

throughout the nation that provide 

distinct reporting criteria for program 

participation. 

II. Request for Information 

We are seeking input from the public 

on ways in which an eligible 

professional might use the CQM data 

reported to medical boards, specialty 

societies, regional health care quality 

organizations or other non-federal 

reporting programs to fulfill 

requirements of PQRS, and, although we 

are not seeking to change the 

requirements we established for the 

EHR Incentive Program in 2014, the 

EHR Incentive Program. We are seeking 

input on how alignment of certain 

requirements present in both federal 

and non-federal CQM reporting 

programs could reduce the burden for 

eligible professionals and accelerate 

quality improvement. We are also 

seeking input on the amendments made 

by section 601(b) of the American 

Taxpayer Relief Act of 2012. Therefore, 

we are soliciting comment on the 

following questions: 

• High level questions: 

++ How are the current reporting 

requirements for the PQRS and and the 

reporting requirements in 2014 for the 

EHR Incentive Program similar to the 

reporting requirements already 

established for the ABMS boards or to 

other non-federal quality reporting 

programs? How are they different? In 

what ways are these reporting 

requirements duplicative and can these 

reporting programs be integrated to 

reduce reporting burden on eligible 

professionals? 

++ Are there examples of other nonfederal programs under which eligible 

professionals report quality measures 

data? 

++ What would be the benefits and 

shortcomings involved with allowing 

third-party entities to report quality data 

to CMS on behalf of physicians and 

other eligible professionals? 

++ What entities have the capacity to 

report quality data similar to those 

reported under the PQRS, Value-based 

Payment Modifier, and/or EHR 

Incentive programs? If these entities 

were to report such data to CMS, what 

requirements should we include in the 

reporting system used by such entities, 

including requirements to ensure high 

quality data? 

++ How should our quality reporting 

programs change/evolve to reduce 

reporting burden on eligible 

professionals, while still receiving 

robust data on clinical quality? 

• Questions regarding reporting 

requirements for entities that report via 

a registry under the PQRS for 2014 and 

subsequent years or the EHR Incentive 

Program if registry reporting is 

established as a reporting method for 

that program in future years: 

++ What types of entities should be 

eligible to submit quality measures data 

on behalf of eligible professionals for 

PQRS and the EHR Incentive Program? 

Examples might include medical board 

registries, specialty society registries, 

regional quality collaboratives or other 

entities. What qualification 

requirements should be applicable to 

such entities? 

++ What functionalities should 

entities qualified to submit PQRS 

quality measures data possess? For 

example, for CQMs that can be 

electronically submitted and reported 

under PQRS and the EHR Incentive 

Program, should an entity’s 

qualification to submit such measures 

be based on whether they have 

technology certified to ONC’s 

certification criteria for CQM 

calculation and/or electronic 

submission? 

++ What criteria should we require of 

entities submitting quality measures 

data to us on behalf of eligible 

professionals? Examples might include 

transparency of measures available to 

EPs, specific frequency of feedback 

reports, tools to guide improvement 

efforts for EPs, ability to report aggregate 

data, agreement to data audits if 

requested, etc. 

++ Should reporting entities be 

required to publicly post performance 

data? 

++ Should we require an entity to 

submit a yearly self-nomination 

statement to participate in PQRS? 

++ What should be included in the 

data validation plan for these reporting 

entities? 

++ If CMS provided a reporting 

option for PQRS and/or the EHR 

Incentive Program through such entities, 

what specification should CMS use to 

receive the quality data information (for 

example, Quality Reporting Document 

Architecture [QRDA] 1 or 3, XML, 

other)? 

++ Should data submission timelines 

for these reporting entities be modified 

so that the submission timeframes for 

these quality reporting programs are 

aligned? For example, PQRS qualified 

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9060 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices 

registries are required to submit quality 

measures data once, within 2 months 

following the reporting period. How 

much time are reporting entities outside 

of PQRS afforded to submit quality 

measures data? What challenges do 

reporting entities face in reporting data 

according to current timeframes? 

++ What oversight (for example, 

checks or audits) should be in place to 

ensure that data is submitted and 

calculated properly by entities? 

• Questions regarding selection of 

measures related to registry reporting 

under PQRS for 2014 and subsequent 

years and for the EHR Incentive Program 

if registry reporting is established as a 

reporting method for that program in 

future years: 

++ Should we require that a certain 

proportion of submitted measures have 

particular characteristics such as being 

NQF-endorsed or outcome-based? 

++ Should we require that the quality 

measures data submitted cover a certain 

number of the six national quality 

strategy domains? 

++ To what extent would third-party 

entities struggle to meet reporting for 

measures currently available under 

PQRS and EHR Incentive Program? 

• Questions regarding registry 

measures reporting criteria: 

++ If we propose revised criteria for 

satisfactory reporting under PQRS and 

for meeting the CQM component of 

meaningful use under the EHR Incentive 

Program, how many measures should an 

eligible professional be required to 

report to collect meaningful quality 

data? For example, for reporting periods 

occurring in 2014, eligible professionals 

using CEHRT must report 9 measures 

covering at least 3 domains to meet the 

criteria for satisfactory reporting for the 

2014 PQRS incentive and meet the CQM 

component of achieving meaningful use 

for the EHR Incentive Program. (For 

more information see the EHR Incentive 

Program Stage 2 final rule (77 FR 54058) 

and the CY 2013 Medicare PFS final 

rule with comment period (77 FR 

69192).) If we were to align reporting 

criteria with reporting requirements for 

other non-federal reporting programs, in 

future years, should we propose to 

require reporting on a different number 

of measures than what is currently 

required for the PQRS in 2013 and the 

EHR Incentive Program under the Stage 

2 final rule or should the non-federal 

reporting programs align with CMS 

criteria? 

++ For PQRS, should eligible 

professionals still be required to report 

quality measures data on a certain 

percentage of their applicable patients, 

such as 80 percent, for 2014 and 

subsequent years? Or, should we require 

that eligible professionals report on a 

certain minimum number of patients, 

such as 20, rather than a percentage? 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: January 9, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–02703 Filed 2–4–13; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0001] 

Request for Nominations for Voting 

Members on Public Advisory Panels or 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Device Good 

Manufacturing Practice Advisory 

Committee, certain device panels of the 

Medical Devices Advisory Committee, 

the National Mammography Quality 

Assurance Advisory Committee, and the 

Technical Electronic Products Radiation 

Safety Standards Committee in the 

Center for Devices and Radiological 

Health. Nominations will be accepted 

for current vacancies and those that will 

or may occur through December 31, 

2013. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees, and therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Because scheduled vacancies 

occur on various dates throughout each 

year, no cutoff date is established for the 

receipt of nominations. However, when 

possible, nominations should be 

received at least 6 months before the 

date of scheduled vacancies for each 

year, as indicated in this notice. 

ADDRESSES: All nominations for 

membership should be sent 

electronically to cv@oc.fda.gov, or by 

mail to Advisory Committee Oversight & 

Management Staff, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5103, 

Silver Spring, MD 20993–0002. 

Information about becoming a member 

on a FDA advisory committee can also 

be obtained by visiting FDA’s Web site 

at http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

FOR FURTHER INFORMATION CONTACT: For 

specific Committee/Panel questions, 

contact the following persons listed in 

table 1 of this document. 

TABLE 1 

Contact person Committee/certain device panels of the medical devices advisory committee 

LCDR Sara Anderson, Center for Devices and Radiological Health, 

Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 

66, rm. 1544, Silver Spring, MD 20993, 301–796–7046, email: 

Sara.Anderson@fda.hhs.gov.

National Mammography Quality Assurance Advisory Committee. 

Dental Products Panel. 

Hematology and Pathology Devices Panel. 

Orthopaedic and Rehabilitation Devices Panel. 

Shanika Craig, Center for Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 

1613, Silver Spring, MD 20993, 301–796–6639, email: 

Shanika.Craig@fda.hhs.gov.

Technical Electronic Product Radiation Safety Standards Committee. 

Anesthesiology and Respiratory Therapy Devices Panel. 

Gastroenterology and Urology Devices Panel. 

Microbiology Devices Panel. 

Obstetrics and Gynecology Devices Panel. 

Radiological Devices Panel. 

Natasha Facey, Center for Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 

1544, Silver Spring, MD 20993, 301–796–5290, email: 

Natasha.Facey@fda.hhs.gov.

Device Good Manufacturing Practice Advisory Committee. 

General Hospital and Personal Use Devices Panel. 

Immunology Devices Panel. 

Ophthalmic Devices Panel. 

Neurological Devices Panel. 

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