Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices 33313 

1See http://www.fda.gov/ForIndustry/Data

Standards/StructuredProductfxsp0;Labeling/ 

ucm162549.htm. 

2FDA News: http://www.fda.gov/NewsEvents/ 

Newsroom/PressAnnouncements/2006/ 

ucm108642.htm 

3SNOMED CT VA/KP subset: http:// 

www.nlm.nih.gov/research/umls/Snomed/snomed_

problem_list.html 

approval process, FDA identifies the 

established pharmacologic class for each 

approved medical product if 

appropriate. An established 

pharmacologic class is one that FDA has 

determined is scientifically valid and 

clinically meaningful according to the 

principles outlined in the guidance for 

industry and review staff ‘‘Labeling for 

Human Prescription Drugs and 

Biological Products—Determining 

Established Pharmacologic Class for Use 

in the Highlights of Prescribing 

Information,’’ published in October 

2009. 

For SPL indexing, the established 

pharmacologic class is represented by 

an established pharmacologic class term 

or phrase. FDA also uses the 

Department of Veterans Affairs National 

Drug File Reference Terminology to 

identify other scientifically valid and 

clinically meaningful SPL indexing 

terms for each active ingredient that are 

representative of mechanism of action, 

physiologic effect, and chemical 

structure. 

On the FDA Data Standards Council 

Web site, FDA has posted a Microsoft 

Excel spreadsheet containing a list of 

proposed established pharmacologic 

classes and indexing concepts 

completed to date for each active 

ingredient associated with approved 

human prescription drug and biological 

products.1

III. Indexing Indications Information 

FDA has determined that another high 

priority for indexing of product labeling 

information, as resources permit, is the 

medical product indications category. 

With indexing of indications, the goal 

is to determine terms or phrases that 

represent the recognized disease or 

condition, manifestation of a recognized 

disease or condition, or symptoms 

associated with a recognized disease or 

condition that accurately capture the 

approved indication appearing in the 

Indications section of labeling. The 

current intent is to index the basic 

indication concepts without the more 

specific usage and limitations of use 

information. Criteria are under 

development to determine the 

appropriate level of granularity and 

consistency in the choice of concepts 

indexed. 

After consideration of existing 

alternatives including the National 

Library of Medicine’s Clinical 

Observations Recording and Encoding 

(CORE) subset of Systematized 

Nomenclature of Medicine Clinical 

Terms (SNOMED CT), FDA chose the 

Veterans Health Administration and 

Kaiser Permanente (VA/KP) Problem 

List subset of SNOMED CT as the 

terminology for SPL indexing of product 

labeling information on indication.2

SNOMED CT is a comprehensive 

clinical terminology that includes 

expressions for body structures, clinical 

findings, procedures, and hundreds of 

thousands of other clinical concepts. 

More information on SNOMED CT is 

available at http://www.nlm.nih.gov/ 

research/umls/Snomed/ 

snomed_main.html. 

IV. Request for Comments 

FDA is establishing an open docket 

for comments to obtain public input on 

the indexing process. Representatives of 

the human prescription drug and 

biological product industries, health 

care providers, and other health care 

professionals are particularly 

encouraged to participate and submit 

comments. 

FDA is asking for comment on all 

aspects of indexing the content of 

labeling. In particular, FDA is asking for 

comments on the following: 

1. FDA is currently indexing 

pharmacologic class and indications. 

When indexing of these categories is 

complete, FDA plans to index 

additional labeling information 

categories. For example, warnings and 

precautions, other adverse reactions, 

drug interactions, pediatric, or 

pregnancy information may be useful 

categories of information for future 

indexing. Other categories may also be 

identified. Please comment on the 

subsequent labeling categories that 

should be indexed by FDA as well as 

the priority order for indexing these 

categories. 

2. For each indexing category, FDA 

will develop a series of principles to 

ensure the consistent assignment of 

indexing concepts. Please comment on 

the type of principles that may be useful 

for this task. 

3. FDA chose the VA/KP Problem List 

subset of SNOMED CT as the indexing 

terminology for indications for the 

following reasons: 

• The VA/KP Problem List is the 

named SPL data standard terminology 

for indexing the medical condition.3

• The subset represents conditions at 

a level of discreteness that are clinically 

relevant. 

Please comment on the use of the VA/ 

KP Problem List for the indexing of 

indications. 

4. For indications, the degree of 

complexity indexed is limited by FDA’s 

intention to first capture the main focus 

of the indication as a single existing 

concept using the 01312010 version of 

the SNOMED CT VA/KP Problem List 

subset. Additional indication modifiers 

found in approved product labeling 

such as disease severity or chronicity 

will not always be indexed. Please 

comment on this approach. 

5. FDA will use the SPL standard to 

disseminate indexing information. Once 

entered into the SPL file, the indexed 

elements will be available for uploading 

into computer systems for sorting and 

other data manipulations. We believe 

this approach is more user friendly than 

the Microsoft Excel spreadsheet format 

we are currently using to showcase 

pharmacologic class on the Data 

Standards Web site. Please comment on 

this approach to make SPL indexing 

information available to interested 

parties. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

Dated: June 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–14047 Filed 6–10–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1576–N] 

Medicare and Medicaid Programs; 

Procedure for Hospitals Seeking To 

Enter Into an Agreement With a 

Different Organ Procurement 

Organization Following an 1138(a)(2) 

Waiver 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

33314 Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices 

SUMMARY: This notice announces the 

procedures that will be used when a 

hospital, that has previously been 

granted a waiver under sections 

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

Act), seeks to enter into an agreement 

with a different Organ Procurement 

Organization (OPO). The procedures are 

modeled after the public process 

required by 1138(a)(2) of the Act. The 

process affords the public an 

opportunity to comment on the 

proposed change and to submit 

information and material with respect to 

whether the change is likely to increase 

organ donation and will assure 

equitable treatment for patients in both 

affected OPO service areas. 

DATES: Effective Date: This notice is 

effective June 11, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Mark A. Horney, (410) 786–4554. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Organ Procurement Organizations 

(OPOs) are not-for-profit organizations 

that are responsible for the 

procurement, preservation, and 

transport of transplantable 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 CMS-defined 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 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 

§ 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 to identify 

potential donors only with its 

designated OPO. 

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 ensure 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 comment in 

writing during the 60-day period 

beginning on the publication date in the 

Federal Register. 

Several hospitals have asked for and 

been granted waivers to work with a 

hospital other than the designated OPO. 

The statute does not expressly establish 

procedures for the situation where a 

hospital that had previously been 

granted a waiver, desires to enter into an 

agreement with a different OPO or 

return to work with the OPO that has 

been designated for the relevant 

geographic area. Given the importance 

of the hospital-OPO relationship for all 

potential transplant patients in the 

affected service areas, we are 

establishing an open and transparent 

process for addressing these situations. 

Specifically, using the same framework 

provided in section 1138(a)(2), the 

Secretary will enable hospitals that had 

been granted a waiver to apply to enter 

into an agreement with a different OPO. 

A specific notice will be published in 

the Federal Register within 30 days of 

the agency’s receipt of such a request. 

We will provide the public an 

opportunity to submit information and 

material with respect to whether the 

proposed change would be expected to 

increase organ donation and would 

ensure the equitable treatment for 

transplant patients in both of the 

affected OPO service areas. 

II. Request Procedures 

A hospital that has previously been 

granted a waiver under section 

1138(a)(2) but desiring to enter into an 

agreement with a different OPO, may 

file a request by submitting it to CMS at 

the following address: Director, Centers 

for Medicare and Medicaid Services, 

Division of Technical Payment Policy, 

7500 Security Blvd, C4–25–02, 

Baltimore, MD 21244–1850. 

The letter should supply sufficient 

information and data to address how 

changing OPOs: 

1. Is expected to increase organ 

donation; and 

2. Will assure equitable treatment of 

patients referred for transplant within 

the existing OPO service area, within 

the service area of the OPO with which 

the hospital wishes to enter an 

agreement. 

In making a change in OPO 

determination, the Secretary may 

consider, among other factors: 

1. Cost effectiveness; 

2. Improvements in quality; 

3. Whether there has been a change in 

a hospital’s service due to a change in 

definition of metropolitan statistical 

area (MSA); and 

4. The length and continuity of a 

hospital relationship with the OPO with 

which the hospital wants to align. 

Upon receipt of such a request, we 

would publish a Federal Register notice 

to solicit public comments, consistent 

with the procedures set forth in section 

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

Under these procedures, we will 

review the request and comments 

received. During the review process, we 

may consult on an as-needed basis with 

the Health Resources 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 request and 

notify the hospital and the designated 

and requested OPOs. 

By providing an open and transparent 

public process with an opportunity to 

consider public comments, information 

and materials, the Secretary will be able 

to make better decisions concerning 

whether the proposed change in the 

OPO will be expected to increase organ 

donation and will assure equitable 

treatment for patients in both affected 

OPO service areas. 

III. Collection of Information 

Requirements 

We anticipate receiving less than 10 

hospital requests in a 12-month period. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 112 / Friday, June 11, 2010 / Notices 33315 

Therefore, in accordance with 5 CFR 

1320.3(c), the reporting requirements in 

this notice are not defined as 

information collection requirements. 

(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) 

Dated: June 3, 2010. 

Marilyn Tavenner, 

Acting Administrator and Chief Operating 

Officer, Centers for Medicare & Medicaid 

Services. 

[FR Doc. 2010–14098 Filed 6–10–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meeting 

In accordance with section 10(d) of 

the Federal Advisory Committee Act (5 

U.S.C., Appendix 2), announcement is 

made of a Health Care Policy and 

Research Special Emphasis Panel (SEP) 

meeting. 

A Special Emphasis Panel is a group 

of experts in fields related to health care 

research who are invited by the Agency 

for Healthcare Research and Quality 

(AF[RQ), and agree to be available, to 

conduct on an as needed basis, 

scientific reviews of applications for 

AHRQ support. Individual members of 

the Panel do not attend regularlyscheduled meetings and do not serve for 

fixed terms or a long period of time. 

Rather, they are asked to participate in 

particular review meetings which 

require their type of expertise. 

Substantial segments of the upcoming 

SEP meeting listed below will be closed 

to the public in accordance with the 

Federal Advisory Committee Act, 

section 10(d) of 5 U.S.C., Appendix 2 

and 5 U.S.C. 552b(c)(6). Grant 

applications for the OS ARRA: 

Clinically-Enhanced State Data for 

Analysis for CE Impact (R01) 

applications are to be reviewed and 

discussed at this meeting. These 

discussions are likely to reveal personal 

information concerning individuals 

associated with the applications. This 

information is exempt from mandatory 

disclosure under the above-cited 

statutes. 

SEP Meeting on: OS ARRA: 

Clinically-Enhanced State Data for 

Analysis for CE Impact (R01). 

Date: July 2, 2010. (Open on July 2 

from 8 a.m. to 8:15 a.m. and closed for 

the remainder of the meeting.) 

Place: Hyatt Regency Bethesda Hotel, 

7400 Wisconsin Avenue, 1 Bethesda 

Metro Center, Conference Room TBD, 

Bethesda, MD 20814. 

Contact Person: Anyone wishing to 

obtain a roster of members, agenda or 

minutes of the non-confidential portions 

of this meeting should contact Mrs. 

Bonnie Campbell, Committee 

Management Officer, Office of 

Extramural Research, Education and 

Priority Populations, AHRQ, 540 

Gaither Road, Room 2038, Rockville, 

Maryland 20850, Telephone (301) 427– 

1554. 

Agenda items for this meeting are 

subject to change as priorities dictate. 

Dated: May 27, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–13982 Filed 6–10–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Research 2 

Practice and Construction Research 

Application, Request for Application 

(RFA) OH09–001, Initial Review 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), 

announces the aforementioned meeting: 

Time and Date: 3 a.m.–5 p.m., July 7, 2010 

(Closed). 

Place: National Institute for Occupational 

Safety and Health (NIOSH), 2400 Century 

Parkway, NE., Fourth Floor, Atlanta, Georgia 

30345, Telephone: (404) 498–2530. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5, 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Section 10(d) of Public Law 

92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Research 2 Practice and 

Construction Research Application, RFA 

OH09–001’’. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: Chris 

Langub, PhD, Scientific Review Officer, 

NIOSH, CDC, 2400 Century Center, Atlanta, 

GA 30333, Telephone: (404) 498–2543. 

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 CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: June 4, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–14074 Filed 6–10–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0268] 

Dental Products Panel of the Medical 

Devices Advisory Committee; Notice of 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Dental Products 

Panel of the Medical Devices Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on December 14 and 15, 2010, from 

8 a.m. to 6 p.m. 

Location: Holiday Inn-Gaithersburg, 

Main Ballroom, 2 Montgomery Village 

Ave., Gaithersburg, MD 20879. 

Contact Person: Olga I. Claudio, Food 

and Drug Administration, Center for 

Devices and Radiological Health, WO 

66, rm. 1553, Silver Spring, MD 20993– 

0002, 301–796–7608 or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 301–451– 

2518. Please call the Information Line 

for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Comments: FDA is opening a docket 

for public comment on this document. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES