98 Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Determination Concerning a Petition 

To Add a Class of Employees to the 

Special Exposure Cohort 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention, Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HHS gives notice of a 

determination concerning a petition to 

add a class of employees from the 

United Nuclear Corporation in 

Hematite, Missouri, to the Special 

Exposure Cohort (SEC) under the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000 

(EEOICPA), 42 U.S.C. 7384q. On 

December 7, 2012, the Secretary of HHS 

determined that the following class of 

employees does not meet the statutory 

criteria for addition to the SEC as 

authorized under EEOICPA: 

All site employees who worked in any area 

of the United Nuclear Corporation— 

Hematite, Missouri, site from January 1, 

1958, through December 31, 1973, and the 

residual period January 1, 1974, through July 

31, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Stuart L. Hinnefeld, Director, Division 

of Compensation Analysis and Support, 

National Institute for Occupational 

Safety and Health (NIOSH), 4676 

Columbia Parkway, MS C–46, 

Cincinnati, OH 45226, Telephone 1– 

877–222–7570. Information requests can 

also be submitted by email to 

DCAS@CDC.GOV. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health. 

[FR Doc. 2012–31215 Filed 12–31–12; 8:45 am] 

BILLING CODE 4163–19–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 the 

2014 Edition EHR certification criteria 

under the ONC HIT Certification 

Program. The approved test tools and 

test procedures are identified on the 

ONC Web site at: http:// 

www.healthit.gov/policy-researchersimplementers/2014-edition-final-testmethod. 

FOR FURTHER INFORMATION CONTACT: 

Carol Bean, Director, Office of 

Certification, Office of the National 

Coordinator for Health Information 

Technology, 202–690–7151. 

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 EHR Certification 

Criteria final rule the Secretary adopted 

the 2014 Edition EHR certification 

criteria. The National Coordinator has 

approved test tools and test procedures 

for testing EHR technology to the 2014 

Edition EHR certification criteria under 

the ONC HIT Certification Program. 

These approved test tools and test 

procedures are identified on the ONC 

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

policy-researchers-implementers/2014- 

edition-final-test-method. 

Authority: 42 U.S.C. 300jj–11. 

Dated: December 19, 2012. 

Farzad Mostashari M.D., 

National Coordinator for Health Information 

Technology. 

[FR Doc. 2012–31484 Filed 12–31–12; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1456–NC] 

Medicare and Medicaid Programs; 

Announcement of Application From a 

Hospital Requesting Waiver for Organ 

Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: A hospital has requested a 

waiver of statutory requirements that 

would otherwise require the hospital to 

enter into an agreement with its 

designated Organ Procurement 

Organization (OPO). The request was 

made in accordance with section 

1138(a)(2) of the Social Security Act (the 

Act). This notice requests comments 

from OPOs and the general public for 

our consideration in determining 

whether we should grant the requested 

waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

March 4, 2013. 

ADDRESSES: In commenting, please refer 

to file code CMS–1456–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 instructions under the ‘‘More Search 

Options’’ tab. 

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–1456–NC, P.O. Box 8010, 

Baltimore, MD 21244–1850. 

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: Department of 

Health and Human Services, Attention: 

CMS–1456–NC, Mail Stop C4–26–05, 

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: 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices 99 

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: 

Patricia Taft, (410) 786–4561. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of organs to transplant centers 

throughout the country. Qualified OPOs 

are designated by the Centers for 

Medicare & Medicaid Services (CMS) to 

recover or procure organs in CMSdefined exclusive geographic service 

areas, pursuant to section 371(b)(1) of 

the Public Health Service Act (42 U.S.C. 

273(b)(1)) and our regulations at 42 CFR 

486.306. Once an OPO has been 

designated for an area, hospitals in that 

area that participate in Medicare and/or 

Medicaid are required to work with that 

OPO in providing organs for transplant, 

pursuant to section 1138(a)(1)(C) of the 

Social Security Act (the Act) and our 

regulations at 42 CFR 482.45. 

Section 1138(a)(1)(A)(iii) of the Act 

provides that a hospital must notify the 

designated OPO (for the service area in 

which it is located) of potential organ 

donors. Under section 1138(a)(1)(C) of 

the Act, every participating hospital 

must have an agreement only with its 

designated OPO to identify potential 

donors. 

However, section 1138(a)(2)(A) of the 

Act provides that a hospital may obtain 

a waiver of the above requirements from 

the Secretary under certain specified 

conditions. A waiver allows the hospital 

to have an agreement with an OPO other 

than the one initially designated by 

CMS, if the hospital meets certain 

conditions specified in section 

1138(a)(2)(A) of the Act. In addition, the 

Secretary may review additional criteria 

described in section 1138(a)(2)(B) of the 

Act to evaluate the hospital’s request for 

a waiver. 

Section 1138(a)(2)(A) of the Act states 

that in granting a waiver, the Secretary 

must determine that the waiver—(1) is 

expected to increase organ donations; 

and (2) will assure equitable treatment 

of patients referred for transplants 

within the service area served by the 

designated OPO and within the service 

area served by the OPO with which the 

hospital seeks to enter into an 

agreement under the waiver. In making 

a waiver determination, section 

1138(a)(2)(B) of the Act provides that 

the Secretary may consider, among 

other factors: (1) Cost-effectiveness; (2) 

improvements in quality; (3) whether 

there has been any change in a 

hospital’s designated OPO due to the 

changes made in definitions for 

metropolitan statistical areas; and (4) 

the length and continuity of a hospital’s 

relationship with an OPO other than the 

hospital’s designated OPO. Under 

section 1138(a)(2)(D) of the Act, the 

Secretary is required to publish a notice 

of any waiver application received from 

a hospital within 30 days of receiving 

the application, and to offer interested 

parties an opportunity to submit 

comments during the 60-day comment 

period beginning on the publication 

date in the Federal Register. 

The criteria that the Secretary uses to 

evaluate the waiver in these cases are 

the same as those described above under 

sections 1138(a)(2)(A) and (B) of the Act 

and have been incorporated into the 

regulations at § 486.308(e) and (f). 

II. Waiver Request Procedures 

In October 1995, we issued a Program 

Memorandum (Transmittal No. A–95– 

11) detailing the waiver process and 

discussing the information hospitals 

must provide in requesting a waiver. We 

indicated that upon receipt of a waiver 

request, we would publish a Federal 

Register notice to solicit public 

comments, as required by section 

1138(a)(2)(D) of the Act. 

According to these requirements, we 

will review the comments received. 

During the review process, we may 

consult on an as-needed basis with the 

Health Resources and Services 

Administration’s Division of 

Transplantation, the United Network for 

Organ Sharing, and our regional offices. 

If necessary, we may request additional 

clarifying information from the applying 

hospital or others. We will then make a 

final determination on the waiver 

request and notify the hospital and the 

designated and requested OPOs. 

III. Hospital Waiver Request 

As permitted by § 486.308(e), the 

following hospital has requested a 

waiver to enter into an agreement with 

a designated OPO other than the OPO 

designated for the service area in which 

the hospital is located: Bolivar Medical 

Center in Cleveland, Mississippi, is 

requesting a waiver to work with: 

Mississippi Organ Recovery Agency, 

4400 Lakeland Drive, Flowood, MS 

39232. 

The Hospital’s Designated OPO is: 

Mid-South Transplant Foundation, Inc., 

8001 Centerview Parkway, Suite 302, 

Memphis, TN 38018. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; Program No. 93.774, Medicare— 

Supplementary Medical Insurance, and 

Program No. 93.778, Medical Assistance 

Program) 


tkelley on DSK3SPTVN1PROD with 
100 Federal Register / Vol. 78, No. 1 / Wednesday, January 2, 2013 / Notices 

Dated: December 19, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–31535 Filed 12–31–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0523] 

Guidance for Industry and Food and 

Drug Administration Staff; Refuse To 

Accept Policy for 510(k)s; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Refuse to Accept Policy for 510(k)s.’’ 

The purpose of this document is to 

explain the procedures and criteria FDA 

intends to use in determining whether 

a 510(k) submission is administratively 

complete, which determines whether it 

should be accepted for substantive 

review and clearance. This guidance is 

applicable to 510(k)s reviewed in the 

Center for Devices and Radiological 

Health (CDRH) and the Center for 

Biologics Evaluation and Research 

(CBER). 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Refuse to Accept Policy for 

510(k)s’’ to the Division of Small 

Manufacturers, International and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 4613, 

Silver Spring, MD 20993–0002; or Office 

of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

that office in processing your request, or 

fax your request to 301–847–8149. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the guidance. 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT:

Geeta Pamidimukkala, Center for 

Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, rm. 

1564, Silver Spring, MD 20993–0002, 

301–796–6453; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPLEMENTARY INFORMATION: 

I. Background 

The purpose of the 510(k) acceptance 

review is to make a threshold 

determination whether a submission is 

administratively complete, which 

determines whether it should be 

accepted for substantive review to reach 

a determination regarding substantial 

equivalence under section 513(i) of the 

FD&C Act, 21 U.S.C. 360c(i). To find a 

device substantially equivalent under 

section 513(i) of the FD&C Act, FDA 

must find that it has the same intended 

use as the predicate device, and either: 

(1) Has the same technological 

characteristics as the predicate device, 

or (2) has different technological 

characteristics, as defined at section 

513(i)(1)(B), and (3) the submission 

contains information, including 

appropriate clinical or scientific data if 

necessary, that demonstrates the device 

is as safe and effective as the predicate 

and does not raise different questions of 

safety and effectiveness from the 

predicate. 

The purpose of this document is to 

explain the procedures and criteria FDA 

intends to use in determining whether 

a 510(k) submission is administratively 

complete and should be accepted for 

substantive review. This guidance 

document provides updated information 

to two existing guidance documents 

entitled ‘‘Center for Devices and 

Radiological Health’s Premarket 

Notification (510(k)) Refuse to Accept 

Policy’’ issued on June 30, 1993 and 

‘‘510(k) Refuse to Accept Procedures, 

510(k) Memorandum K94–1’’ issued on 

May 20, 1994. Upon issuance as a final 

guidance document, this guidance will 

replace those documents. 

To further focus the Agency’s review 

resources on complete applications, 

which will provide a more efficient 

approach to ensuring that safe and 

effective medical devices reach patients 

as quickly as possible, we have 

modified the 1993 and 1994 guidances. 

For example, we have modified the 

510(k) Refuse to Accept (RTA) policy to 

include an early review against specific 

acceptance criteria and to inform the 

submitter within the first 15 calendar 

days of receipt of the submission if the 

submission is administratively 

complete, or if not, to identify the 

missing element(s). In order to enhance 

the consistency of our acceptance 

decisions and to help submitters better 

understand the types of information 

FDA needs to conduct a substantive 

review, this guidance, including the 

checklists included in the appendices, 

clarifies the necessary elements and 

contents of a complete 510(k) 

submission. These elements are 

applicable to all devices reviewed 

through the 510(k) notification process 

in CDRH and CBER and have been 

compiled into checklists for use by FDA 

review staff. 

In the Federal Register of August 13, 

2012 (77 FR 48159), FDA announced the 

availability of the draft guidance 

document. Interested persons were 

invited to comment by September 27, 

2012. Eleven sets of comments were 

received with multiple 

recommendations pertaining to the 

administrative processes and policies 

regarding 510(k) acceptance decisions. 

A number of commenters expressed 

concern that the checklist questions 

related to performance data implied that 

FDA staff would need to conduct a level 

of substantive review in order to 

complete the checklist. FDA has revised 

the language in these questions and 

added further instructions to FDA staff 

to more specifically state that only the 

presence of the information is required 

for acceptance, and that the adequacy of 

the information should only be assessed 

after acceptance and as part of the 

substantive review. 

Similar comments were received 

regarding questions in the checklists 

that identified an ‘‘analysis’’ or 

‘‘discussion’’ as a criterion for 

acceptance. Commenters were 

concerned that FDA staff would be 

assessing the adequacy of the ‘‘analysis’’ 

or ‘‘discussion’’ in order to complete the 

checklist. These questions have also 

been modified to explain more clearly 

that the acceptance criterion requires 

only that the ‘‘analysis’’ or ‘‘discussion’’ 

be present; the adequacy of this 

information should be assessed during 

the substantive review. 

FDA received comments regarding 

relevant prior submissions and how 

prior FDA feedback relevant to 

determining substantial equivalence has 

been addressed in the submission under 


tkelley on DSK3SPTVN1PROD with