14606 Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Notices 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, Conference 

Room 9S235, Bethesda, MD 20892. 

Time: May 14, 2010, 8:15 a.m. to 3 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, Conference 

Room 9S235, Bethesda, MD 20892. 

Contact Person: Ira W. Levin, PhD, 

Director, Division of Intramural Research, 

National Institute of Diabetes and Digestive 

and Kidney Diseases, NIH, Bethesda, MD 

20892. 301–496–6844. iwl@helix.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: March 18, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–6675 Filed 3–25–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1570–N] 

Medicare Program; Request for 

Nominations to the Advisory Panel on 

Ambulatory Payment Classification 

Groups 

AGENCY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice solicits 

nominations of five new members to the 

Advisory Panel on Ambulatory Payment 

Classification (APC) Groups (the Panel). 

There will be five vacancies on the 

Panel as of September 30, 2010. 

The purpose of the Panel is to review 

the APC groups and their associated 

weights and to advise the Secretary of 

the Department of Health and Human 

Services (DHHS) and the Administrator 

of the Centers for Medicare & Medicaid 

Services (CMS), concerning the clinical 

integrity of the APC groups and their 

associated weights. 

The Secretary re-chartered the Panel 

in 2008 for a 2-year period effective 

through November 21, 2010. 

DATES: Submission of Nominations: We 

will consider nominations if they are 

received no later than 5 p.m. (e.s.t.), 

May 26, 2010. 

ADDRESSES: Please mail or hand deliver 

nominations to the following address: 

Centers for Medicare & Medicaid 

Services; Attn: Shirl Ackerman-Ross, 

Designated Federal Official (DFO), 

Advisory Panel on APC Groups; Center 

for Medicare Management, Hospital & 

Ambulatory Policy Group, Division of 

Outpatient Care; 7500 Security 

Boulevard, Mail Stop C4–05–17; 

Baltimore, MD 21244–1850. 

Web Site: For additional information 

on the APC Panel and updates to the 

Panel’s activities, we refer readers to 

view our website at the following: 

http://www.cms.hhs.gov/FACA/05_

AdvisoryPanelonAmbulatoryPayment

ClassificationGroups.asp#TopOfPage. 

(Use control + click the mouse in order 

to access the previous URL.) (Note: 

There is an underscore after FACA/05_; 

there is no space.) 

FOR FURTHER INFORMATION CONTACT: 

Contact: Persons wishing to nominate 

individuals to serve on the Panel or to 

obtain further information may also 

contact Shirl Ackerman-Ross, the DFO, 

at CMS APCPanel@cms.hhs.gov (Note: 

There is no underscore in this e-mail 

address; there is a SPACE between CMS 

and APCPanel.), or e-mail the DFO at 

SAckermanross@cms.hhs.gov. 

Advisory Committees’ Information 

Lines: You may also refer to the CMS 

Federal Advisory Committee Hotlines at 

1–877–449–5659 (toll-free) or 410–786– 

9379 (local) for additional information. 

News Media: Representatives should 

contact the CMS Press Office at 202– 

690–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Secretary is required by section 

1833(t)(9)(A) of the Social Security Act 

(the Act) to consult with an expert 

outside advisory Panel regarding the 

clinical integrity of the APC groups and 

relative payment weights that are 

components of the Medicare hospital 

Outpatient Prospective Payment System 

(OPPS). 

The Charter requires that the Panel 

meet up to three times annually. CMS 

considers the technical advice provided 

by the Panel as we prepare the proposed 

and final rules to update the OPPS for 

the next calendar year. 

The Panel may consist of a chair and 

up to 15 members who are full-time 

employees of hospitals, hospital 

systems, or other Medicare providers 

that are subject to the OPPS. (For 

purposes of the Panel, consultants or 

independent contractors are not 

considered to be full-time employees in 

these organizations.) 

The current Panel members are as 

follows: (Note: The asterisks [*] indicate 

the Panel members whose terms end on 

September 30, 2010.) 

• E. L. Hambrick, M.D., J.D., Chair, a 

CMS Medical Officer 

• Ruth L. Bush, M.D., M.P.H. 

• Dawn L. Francis, M.D., M.H.S. 

• Kathleen M. Graham, R.N., MSHA, 

CPHQ 

• Patrick A. Grusenmeyer, Sc.D., 

FACHE 

• David Halsey, M.D. 

• Judith T. Kelly, B.S.H.A., RHIT, 

RHIA, CCS 

• Michael D. Mills, Ph.D.* 

• Agatha L. Nolen, D.Ph., M.S., 

FASHP 

• Randall A. Oyer, M.D. 

• Beverly Khnie Philip, M.D.* 

• Daniel Pothen, M.S., RHIA, 

CPHIMS, CCS, CCS–P, CHC 

• Gregory J. Przbylski, M.D. 

• Russ Ranallo, M.S., B.S.* 

• Michael A. Ross, M.D., FACEP * 

• Patricia Spencer-Cisek, M.S., 

APRN–BC, AOCN® * 

Panel members serve without 

compensation, according to an advance 

written agreement. However, for the 

meetings, CMS reimburses travel, meals, 

lodging, and related expenses in 

accordance with standard Government 

travel regulations. 

CMS has a special interest in 

attempting to ensure, while taking into 

account the nominee pool, that the 

Panel is diverse in all respects of the 

following: Geography; rural or urban 

practice; race, ethnicity, sex, and 

disability; medical or technical 

specialty; and type of hospital, hospital 

health system, or other Medicare 

provider subject to the OPPS. 

Based upon either self-nominations or 

nominations submitted by providers or 

interested organizations, the Secretary, 

or his or her designee, appoints new 

members to the Panel from among those 

candidates determined to have the 

required expertise. New appointments 

are made in a manner that ensures a 

balanced membership under the 

guidelines of the Federal Advisory 

Committee Act. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 58 / Friday, March 26, 2010 / Notices 14607 

II. Criteria for Nominees 

The Panel must be fairly balanced in 

its membership in terms of the points of 

view represented and the functions to 

be performed. The Panel shall consist of 

up to 15 members who are 

representatives of providers. Each Panel 

member must be employed full-time by 

a hospital, hospital system, or other 

Medicare provider subject to payment 

under the OPPS. All members must 

have technical expertise to enable them 

to participate fully in the Panel’s work. 

Such expertise encompasses hospital 

payment systems; hospital medical care 

delivery systems; provider billing 

systems; APC groups; Current 

Procedural Terminology codes; and 

alpha-numeric Health Care Common 

Procedure Coding System codes; and 

the use of, and payment for, drugs and 

medical devices, as well as other forms 

of relevant expertise. 

It is not necessary for a nominee to 

possess expertise in all of the areas 

listed, but each must have a minimum 

of 5 years experience and currently have 

full-time employment in his or her area 

of expertise. Generally, members of the 

Panel serve overlapping terms of 4 

years, based on the needs of the Panel 

and contingent upon the re-chartering of 

the Panel. 

Any interested person or organization 

may nominate one or more qualified 

individuals. Self-nominations will also 

be accepted. Each nomination must 

include the following: 

• Letter of Nomination, 

• Curriculum Vitae of the nominee, 

and 

• Written statement from the nominee 

that the nominee is willing to serve on 

the Panel under the conditions 

described in this notice and further 

specified in the Charter. 

III. Copies of the Charter 

To obtain a copy of the Panel’s 

Charter, submit a written request to the 

DFO at the address provided in the 

ADDRESSES section or by e-mail at CMS 

APCPanel@cms.hhs.gov, or call 410– 

786–4474. 

Copies of the Charter are also 

available on the Internet at the 

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

FACA/05_

AdvisoryPanelonAmbulatoryPayment

ClassificationGroups.asp#TopOfPage. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare— 

Supplementary Medical Insurance Program) 

Dated: March 18, 2010. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2010–6789 Filed 3–25–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0141] 

Small Entity Compliance Guide: 

Bottled Water: Total Coliform and E. 

coli; 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 ‘‘Bottled Water: Total Coliform 

and E. coli—Small Entity Compliance 

Guide’’ for a final rule published in the 

Federal Register of May 29, 2009. This 

small entity compliance guide (SECG) is 

intended to set forth in plain language 

the requirements of the regulation and 

to help small businesses understand the 

regulation. 

DATES: Submit electronic or written 

comments on the SECG at any time. 

ADDRESSES: Submit electronic 

comments on the SECG to http:// 

www.regulations.gov. Submit written 

comments on the SECG to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852. Submit written requests for 

single copies of the SECG to the 

Division of Plant and Dairy Food Safety 

(HFS–317), Office of Food Safety, Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740, or fax your request to 301–436– 

2651. Send one self-addressed adhesive 

label to assist that office in processing 

your request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the SECG. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Posnick Robin, Center for Food 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1639. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 29, 

2009 (74 FR 25651), FDA issued a final 

rule amending its bottled water 

regulations to require that bottled water 

manufacturers test source water for total 

coliform, as is required for finished 

bottled water products, and to require, 

if any coliform organisms are detected 

in source water, that bottled water 

manufacturers determine whether any 

of the coliform organisms are 

Escherichia coli (E. coli), an indicator of 

fecal contamination. FDA also amended 

its bottled water regulations to require, 

if any coliform organisms are detected 

in finished bottled water products, that 

bottled water manufacturers determine 

whether any of the coliform organisms 

are E. coli. FDA also amended the 

adulteration provision of the bottled 

water standard to reflect the possibility 

of adulteration caused by the presence 

of filth. Under the amended regulations, 

bottled water containing E. coli will be 

considered adulterated, and source 

water containing E. coli will not be 

considered to be of a safe, sanitary 

quality and will be prohibited from use 

in the production of bottled water. FDA 

also amended its bottled water 

regulations to require that, before a 

bottler can use source water from a 

source that has tested positive for E. 

coli, the bottler must take appropriate 

measures to rectify or eliminate the 

cause of E. coli contamination of that 

source, and that the bottler must keep 

records of such actions. Existing 

regulatory provisions require bottled 

water manufacturers to keep records of 

new testing required by this rule. The 

effective date of the final rule is 

December 1, 2009. 

FDA examined the economic 

implications of the final rule as required 

by the Regulatory Flexibility Act (5 

U.S.C. 601–612). Because the costs per 

entity of this rule are small, the agency 

believes that the final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

However, FDA could not certify that the 

final rule would not have a significant 

economic impact on a substantial 

number of small entities. Therefore, in 

compliance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (Public Law 104–121), FDA 

is making available this SECG stating in 

plain language the legal requirements of 

the May 29, 2009, final rule set forth in 

21 CFR parts 129 and 165 concerning 

the monitoring requirements for total 

coliform and E. coli in source water and 

finished bottled water products, the 

allowable levels of total coliform and E. 


emcdonald on DSK2BSOYB1PROD with NOTICES