69976 Federal Register / Vol. 70, No. 222 / Friday, November 18, 2005 / Notices 

1Under 21 CFR 316.3(b)(2), ‘‘active moiety’’

means the molecule or ion, excluding those 

appended portions of the molecule that cause the 

drug to be an ester, salt (including a salt with 

hydrogen or coordination bonds), or other 

noncovalent derivative (such as a complex, chelate, 

or clathrate) of the molecule, responsible for the 

physiological or pharmacological action of the drug 

substance. 

business application owners to use the 

form flow process of the user 

provisioning service to approve or deny 

requests for access to business 

applications. The primary purpose of 

this system is to implement a unified 

framework for managing user 

information and access rights, for those 

individuals who apply for and are 

granted access across multiple CMS 

systems and business contexts. 

Information in this system will also be 

used to: (1) Support regulatory and 

policy functions performed within the 

Agency or by a contractor or consultant; 

(2) support constituent requests made to 

a Congressional representative; and (3) 

to support litigation involving the 

Agency related to this system. We have 

provided background information about 

the proposed system in the 

‘‘Supplementary Information’’ section 

below. Although the Privacy Act 

requires only that the ‘‘routine use’’

portion of the system be published for 

comment, CMS invites comments on all 

portions of this notice. See ‘‘Effective 

Dates’’ section for comment period; 

Frequency: Other—As required; 

Affected Public: Business or other-forprofit, Individuals or Households, Notfor-profit institutions, Federal 

government, and State, Local, or Tribal 

Government; Number of Respondents: 

60,000,000; Total Annual Responses: 

60,000,000; Total Annual Hours: 

15,000,000. 

2. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Rehabilitation 

Unit Criteria Work Sheet and 

Rehabilitation Hospital Criteria Work 

Sheet and Supporting Regulations at 42 

CFR 488.26; Form Number: CMS–437A 

and CMS–437B (OMB#: 0938–NEW—

NOTE: These instruments are currently 

approved under 0938–0358 but are 

being carved out into a separate 

collection as they are updated more 

frequently.); Use: The rehabilitation 

hospital and rehabilitation unit criteria 

work sheets are necessary to verify that 

these facilities/units comply and remain 

in compliance with the exclusion 

criteria for the Medicare prospective 

payment system; Frequency: Annually; 

Affected Public: Business or other-forprofit, Not-for-profit institutions, and 

State, Local, or Tribal Government; 

Number of Respondents: 1227; Total 

Annual Responses: 1227; Total Annual 

Hours: 306.75. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

address at http://www.cms.hhs.gov/ 

regulations/pra/, or E-mail your request, 

including your address, phone number, 

OMB number, and CMS document 

identifier, to Paperwork@cms.hhs.gov, 

or call the Reports Clearance Office on 

(410) 786–1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received at the address below, no 

later than 5 p.m. on January 17, 2006. 

CMS, Office of Strategic Operations and 

Regulatory Affairs, Division of 

Regulations Development, Attention: 

William N. Parham, III, Room C4–26–

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: November 9, 2005. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 05–22906 Filed 11–17–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005P–0305] 

Request for Comment on the Status of 

Pyridoxamine 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of opportunity to 

comment. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that comments related to the status of 

pyridoxamine may be submitted until 

December 19, 2005. FDA is requesting 

comments in response to the submission 

of a citizen petition requesting, among 

other things, that the agency determine 

the status of pyridoxamine. All 

comments postmarked on or before 

December 19, 2005 will be accepted as 

part of the official record for this matter. 

DATES: Submit written comments by 

December 19, 2005. 

ADDRESSES: Submit written comments 

on the status of pyridoxamine to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Robert Moore, Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1441. 

SUPPLEMENTARY INFORMATION: On July 

29, 2005, FDA received a citizen 

petition submitted, under 21 CFR 10.30, 

by the law firm Morgan Lewis & 

Bockius, LLP, on behalf of BioStratum, 

Inc. The petition requests that the 

agency: (1) State in writing that dietary 

supplements that contain pyridoxamine 

are adulterated under the Federal Food, 

Drug, and Cosmetic Act; (2) exercise its 

enforcement authority under the act to 

remove from interstate commerce 

dietary supplements containing 

pyridoxamine; and (3) not place this 

citizen petition in the agency’s docket 

for premarket notifications for new 

dietary ingredients (Docket No. 2004N–

0454). 

In its citizen petition, BioStratum, 

Inc., states, among other things, that it 

is the manufacturer of Pyridorin 

(pyridoxamine dihydrochloride), which 

is the subject of an investigational new 

drug application (IND) that was filed 

with FDA in July 1999 for use as a 

potential therapeutic agent to slow or 

prevent the progression of diabetic 

nephropathy in patients with type 1 and 

type 2 diabetes. The petition further 

states that substantial clinical trials have 

been conducted for this drug and that 

the existence of those studies has been 

made public. In addition, the petition 

states that pyridoxamine was not 

marketed as a dietary supplement or as 

a food prior to Pyridorin’s authorization 

for investigation as a new drug under an 

IND. 

FDA has considered the information 

and legal argument set forth in the 

petition. Based on the facts set forth in 

the petition, the agency tentatively 

concludes that pyridoxamine, the active 

moiety1 of pyridoxamine 

dihydrochloride, is excluded from the 

dietary supplement definition under the 

exclusion clause in 21 U.S.C. 

321(ff)(3)(B)(ii) and therefore may not be 

marketed as or in a dietary supplement. 

However, although the petition asserts 

that there is no evidence that 

pyridoxamine was marketed as a dietary 

ingredient or as a food prior to the 

authorization of Pyridorin for 

investigation under an IND, the agency 

is interested in receiving information, if 

any, that bears on pyridoxamine’s prior 

marketing as a dietary ingredient or as 

a food, as well as other information that 

would inform the agency’s final 

decision on the status of pyridoxamine. 

Federal Register / Vol. 70, No. 222 / Friday, November 18, 2005 / Notices 69977 

In order to afford all interested parties 

adequate opportunity to participate in 

this matter, the agency requests 

comments and supporting information 

related to this matter. 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 office above between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: November 10, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22884 Filed 11–17–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–05–8004] 

Implementation Plan on the Sharing of 

Confidential Information Between the 

European Commission’s Health and 

Consumer Protection Directorate 

General and the United States Food 

and Drug Administration of the 

Department of Health and Human 

Services 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is providing 

notice of an Implementation Plan on the 

sharing of confidential information 

between the European Commission’s 

Health and Consumer Protection 

Directorate General and the United 

States Food and Drug Administration of 

the Department of Health and Human 

Services. The purpose is for both 

participants to cooperate to facilitate the 

sharing of documents and/or 

information related to food safety. 

DATES: The agreement became effective 

on September 23, 2005. 

FOR FURTHER INFORMATION CONTACT: 

Matthew E. Eckel, Office of 

International Programs (HFG–1), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville MD, 20857, 301–827–

4480; FAX 301–480–0716. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and Implementation Plans between FDA 

and others shall be published in the 

Federal Register, the agency is 

publishing notice of this 

Implementation Plan. 

Dated: November 10, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S