30014 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices 

information provided in these optional 

fields is not required. For example, the 

data contained in the ‘‘Other Names’’

and ‘‘Other Provider Identifiers’’ data 

fields are optional. Further, a primary 

‘‘Healthcare Provider Taxonomy Code’’

is required to be furnished when 

applying for an NPI; however, the 

reporting of additional ‘‘Healthcare 

Provider Taxonomy Codes’’ (a total of 

15 may be reported) is optional. 

The HHS NPPES data dissemination 

policy is as follows: 

1. NPPES health care provider data 

that are required to be disclosed under 

the FOIA will be available as a 

downloadable file on a Web site. 

Section 552(a)(2)(D) of the FOIA 

requires agencies to make available by 

electronic means copies of records 

which have been released to any person 

under the FOIA and which, because of 

the nature of their subject matter, the 

agency determines have become or are 

likely to become the subject of 

subsequent requests for substantially the 

same records. We believe that the 

demand for NPPES health care provider 

data will be such that it will justify our 

making NPPES health care provider data 

that are required to be disclosed under 

the FOIA available for download by the 

public from an Internet Web site. The 

location of the downloadable file will be 

announced on the CMS NPI Web page 

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

NationalProvIdentStand/) prior to its 

availability. Each month, an update file 

will also be available for download from 

the same Web site. The update file will 

not replace the initial file: The update 

file will contain only (1) data that are 

required to be disclosed under FOIA for 

health care providers who obtained 

NPIs within the prior month, and (2) 

updates and changes to the data that are 

required to be disclosed under the FOIA 

for enumerated health care providers 

that were made within the prior month. 

The first update file will be available for 

downloading 30 days after the 

availability of the initial file, and a new 

update file will be available for 

downloading each month thereafter. 

There will be no charge to download 

the files. 

We may decide to discontinue making 

these files available if we determine that 

the query-only database described in (2) 

below is an adequate replacement. 

The NPPES data elements that HHS 

has determined are required to be 

disclosed under FOIA and will be 

contained in the downloadable files are 

listed in the table above. 

2. NPPES health care provider data 

that HHS has determined are required 

to be disclosed under FOIA will be 

available in a query-only database on an 

Internet Web site. 

Section 552(a)(2)(D) of the FOIA 

requires agencies to make available by 

electronic means copies of records 

which have been released to any person 

under the FOIA and which, because of 

the nature of their subject matter, the 

agency determines have become or are 

likely to become the subject of 

subsequent requests for substantially the 

same records. 

We believe that the demand for 

NPPES health care provider data will be 

such that it will justify our making a 

query-only database containing NPPES 

health care provider data that are 

required to be disclosed under the FOIA 

available to the public on an Internet 

Web site. Users will be able to run 

simple queries online, such as queries 

by NPI and by name of health care 

provider. 

There will be no charge to use the 

query-only database. 

The NPPES data elements that HHS 

has determined are required to be 

disclosed under FOIA and will be 

available from the query-only database 

are listed in the table above. 

3. Other requests for NPPES health 

care provider data that HHS has 

determined are required to be disclosed 

under the FOIA. 

Requests for FOIA-disclosable data in 

formats or in media that are not 

described above, or any other custom 

requests, will be considered in 

accordance with the FOIA and CMS 

FOIA procedures and charges (see 

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

04_FOIA.asp). For example, these could 

be requests for FOIA-disclosable data for 

specific health care providers, or for 

health care providers in certain States or 

with certain Healthcare Provider 

Taxonomy Codes, or requests for FOIAdisclosable data on CD, diskette, or 

paper. These requests must be described 

in detail and be submitted to the 

following address: Centers for Medicare 

& Medicaid Services, Office of Strategic 

Operations and Regulatory Affairs, 

Freedom of Information Group, Room 

N2–20–16, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Requests may be sent by fax to (410) 

786–0474. We will not acknowledge, 

respond to, or honor requests that are 

made by telephone. 

III. 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. 3501 et seq.). 

Authority: Sections 1171 through 1179 of 

the Social Security Act (42 U.S.C. 1320d–

1320d–8), as added by section 262 of Pub. L. 

104–191. 42 CFR 162, Subpart D. (Catalog of 

Federal Domestic Assistance Program, No. 

93.773, Medicare—Hospital Insurance 

Program; and No. 93.774, Medicare—

Supplementary Medical Insurance Program) 

Dated: August 30, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: February 22, 2007. 

Michael O. Leavitt 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 07–2651 Filed 5–23–07; 4:12 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0208] 

Interim Melamine and Melamine 

Analogues Safety/Risk Assessment; 

Availability 

AGENCY: Food and Drug Administration, 

HHS 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled, 

‘‘Interim Melamine and Melamine 

Analogues Safety/Risk Assessment.’’

The interim safety/risk assessment 

describes the risk to human health 

associated with eating pork, chicken, 

fish, and eggs from animals that were 

inadvertently fed animal feed that 

contained melamine and its analogues 

(cyanuric acid, ammelide and 

ammeline). FDA is seeking public 

comment on the interim safety/risk 

assessment to assist the agency and the 

Food Safety and Inspection Service 

(FSIS) at the U. S. Department of 

Agriculture (USDA) in the ongoing 

investigation of contaminated vegetable 

protein products imported from China 

that were mislabeled as ‘‘wheat gluten’’

and ‘‘rice protein concentrate,’’ and 

ensuring the safety of the U.S. food 

supply. 

DATES: Comments on the interim safety/ 

risk assessment must be submitted by 

June 29, 2007. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Notices 30015 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: P. 

Michael Bolger, Chief, Risk Assessment 

Staff, Center for Food Safety and 

Applied Nutrition (HFS–308), 5100 

Paint Branch Pkwy., College Park, MD 

20740–3835, 301–436–1941, FAX 301–

436–2632, or e-mail: 

Mike.Bolger@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The interim safety/risk assessment 

was prepared by FDA in collaboration 

with FSIS and in consultation with the 

Centers for Disease Control and 

Prevention, the Environmental 

Protection Agency, and the Department 

of Homeland Security. The purpose of 

the safety/risk assessment is to assist 

FDA and FSIS in the ongoing 

investigation of contaminated vegetable 

protein products imported from China 

that were mislabeled as ‘‘wheat gluten’’

and ‘‘rice protein concentrate,’’ and 

ensuring the safety of the U.S. food 

supply. The interim safety/risk 

assessment concludes that, based on 

currently available data and 

information, the consumption of even 

large amounts of pork, chicken, fish, 

and/or eggs from animals that had been 

inadvertently fed animal feed 

contaminated with melamine and its 

analogues is very unlikely to pose a 

human health risk. This safety/risk 

assessment was developed rapidly due 

to the extremely time-sensitive need to 

understand the nature of the potential 

risk. However, we are seeking public 

comment on this interim safety/risk 

assessment, and in addition it will 

undergo expert peer review. 

II. Safety/Risk Assessment 

A human health safety/risk 

assessment is a scientifically-based 

methodology used to estimate risk to 

human health from exposure to specific 

compounds such as contaminant(s) in 

food. The interim melamine and its 

analogues safety/risk assessment 

addresses: 

(1) The chemical characteristics of 

melamine and its analogues; 

(2) The toxicological profile of 

melamine and its analogues, including 

the observed results from controlled 

animal studies conducted with 

melamine; and 

(3) The likelihood that consumption 

of pork, chicken, fish and eggs from 

animals fed feed contaminated with 

melamine and its analogues poses a 

health risk to humans. 

FDA used the following methodology 

to develop the safety/risk assessment. 

The safety/risk assessment was based on 

the currently available scientific data 

and information. FDA estimated human 

exposure to melamine and its analogues 

based on the estimated levels in specific 

foods and the estimated consumption of 

those foods. The agency compared the 

exposure estimate to a ‘‘Tolerable Daily 

Intake’’ level, which was derived using 

available toxicity data on the level of 

melamine that did not cause adverse 

renal effects in a laboratory-animal (13- 

week rat) bioassay study. FDA adjusted 

this level, ‘‘the No Observed Adverse 

Effect Level’’ for uncertainty in the data 

by dividing by a safety/uncertainty 

factor of 100 to account for differences 

in sensitivity within and across species. 

Recognizing the time-sensitive need 

for the safety/risk assessment, FDA 

invites comments concerning: 

(1) The assessment approach used; 

(2) The assumptions made; 

(3) The data used; and 

(4) The transparency and clarity of the 

report. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

IV. Electronic Access 

The interim safety/risk assessment is 

available electronically at http:// 

www.cfsan.fda.gov/~dms/ 

melamra.html. 

Dated: May 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–2679 Filed 5–25–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Committee on Rural 

Health and Human Services; Notice of 

Meeting 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

that the following committee will 

convene its fifty-sixth meeting. 

Name: National Advisory Committee on 

Rural Health and Human Services. 

Dates and Times: June 10, 2007, 1 p.m.–

5:45 p.m., June 11, 2007, 8:45 a.m.–5 p.m., 

June 12, 2007, 8:50 a.m.–10:45 a.m. 

Place: Fort Collins Hilton, 425 Prospect 

Road, Fort Collins, CO 80526, Phone: 970–

482–2626. 

Status: The meeting will be open to the 

public. 

Purpose: The National Advisory 

Committee on Rural Health and Human 

Services provides advice and 

recommendations to the Secretary with 

respect to the delivery, research, 

development and administration of health 

and human services in rural areas. 

Agenda: Sunday afternoon, June 10, at 

1 p.m., the meeting will be called to order by 

the Chairperson of the Committee, the 

Honorable David Beasley. Jim Wescott, 

Senior Demographer with Colorado State will 

be give an overview of Rural Colorado. 

Following this presentation will be two 

panels on health and human services issues. 

The first will be an health panel. The 

speakers will be Mark Wallace, President of 

Northern Colorado Health Alliance, and Dr. 

Jack Westfall, Associate Dean for Rural 

Health at the Colorado University School of 

Medicine. The second will be a human 

services panel. The speakers will be Patricia 

Brewster-Willeke, a Public Health Nurse, and 

Kindra Mulch, Administrator of Kit Carson 

County Health and Human Services. 

Following the panel discussions will be an 

overview of Monday’s site visits by Lou Ann 

Wilroy with the Colorado State Office of 

Rural Health. The Sunday meeting will close 

at 5:45 p.m. 

Monday morning, June 11, at 8:30 a.m., the 

Committee will break into Subcommittee 

format for the site visits. At 8:45 a.m., both 

Subcommittees will depart for site visits. The 

Health Subcommittee will depart to East 

Morgan County Hospital in Brush, Colorado. 

The Human Services Subcommittee will 

depart to the Area Agency on Aging in Fort 

Morgan, Colorado. Transportation to these 

sites will not be provided. Both 

Subcommittees will return to Fort Collins 

Hilton and resume meeting in Subcommittee 

format at 4 p.m. The Monday meeting will 

close at 5 p.m. 

The final session will be convened 

Tuesday morning, June 12, at 8:50 a.m. A 

Committee member, Mayor Larry Otis, will 

present a case study titled Employee Health 

Care in Rural Mississippi. Following this 

presentation will be a review of the site 

visits, discussion on the letter to the 

Secretary, and discussion of the upcoming 

September meeting. The meeting will be 

adjourned at 10:45 a.m. 

For Further Information Contact: Anyone 

requiring information regarding the 

Committee should contact Tom Morris, 

M.P.A., Executive Secretary, National 

Advisory Committee on Rural Health and 

Human Services, Health Resources and 

Services Administration, Parklawn Building, 

Room 9A–55, 5600 Fishers Lane, Rockville, 

MD 20857, Telephone (301) 443–0835, Fax 

(301) 443–2803. 


sroberts on PROD1PC70 with NOTICES