Federal Register / Vol. 70, No. 222 / Friday, November 18, 2005 / Notices 69975 

certain individuals described in the 

statute as: (1) Undocumented aliens; (2) 

aliens who have been paroled into the 

United States at a United States port of 

entry for the purpose of receiving 

eligible services; and (3) Mexican 

citizens permitted to enter the United 

States for not more than 30 days under 

the authority of a biometric machine 

readable border crossing identification 

card (also referred to as a ‘‘laser visa’’) 

issued in accordance with the 

requirements of regulations prescribed 

under a specific section of the 

Immigration and Nationality Act as 

published in the Bureau of Customs and 

Border Protection’s interim final rule 

dated August 13, 2004.; Frequency: 

Other—as needed; Affected Public: 

Business or other for-profit, Not-forprofit institutions, and State, Local or 

Tribal Governments; Number of 

Respondents: 7,503,000; Total Annual 

Responses: 7,512,000; Total Annual 

Hours: 634,000. 

2. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Electronic Data 

Interchange (EDI) Enrollment Form and 

Centers for Medicare and Medicaid 

Services EDI Registration Form; Form 

No.: CMS–10164 (OMB # 0938–NEW); 

Use: CMS is requiring that providers 

who wish to conduct Electronic Data 

Interchange (EDI) transactions, 

specifically the HIPAA Eligibility 

Inquiry and Response (270/271) directly 

with CMS at the Baltimore data center, 

provide certain information related to 

their organization and/or organizations 

conducting EDI business on their behalf. 

Health care providers, clearinghouses, 

and health plans that wish to access the 

Medicare system for the purposes of 

conducting other EDI business 

transactions are also required to 

complete this form. Furthermore, CMS 

has incorporated changes to the 

collection as a result of public 

comments. One specific comment 

resulted in the combining of the 

information collected related to 

Medicare Modernization Act (MMA) 

section 1011 and Medicare Fee-For 

Service Part A and Part B. Both 

programs collect similar information for 

the purposes of provider enrollment and 

trading partner profile information 

related to the exchange of EDI 

transactions. To further reduce the 

burden on providers enrolling in either 

the MMA section 1011 and/or the 

Medicare Fee-For Service program the 

CMS–10164 collection will change 

terms from ‘‘Carrier/FI’’ to ‘‘Medicare 

contractor’’. The purpose is to 

generically refer to the organization that 

CMS contracts with to operate the 

specific program function such as MMA 

section 1011 or Medicare Part A, 

Medicare Part B for a specific 

jurisdiction. The information will be 

used to assure that profile data for those 

entities that access the section 1011 

and/or Medicare system are entered 

appropriately. Frequency: 

Recordkeeping and Reporting—Other 

(As-Needed); Affected Public: Business 

or other for-profit, Not-for-profit 

institutions; Number of Respondents: 

1,220,000; Total Annual Responses: 

1,220,000; Total Annual Hours: 400,000. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Retiree Drug 

Subsidy (RDS) Application and 

Instructions; Form Number: CMS’10156 

(OMB#: 0938’’ 0957); Use: Under the 

Medicare Prescription Drug, 

Improvement, and Modernization Act 

(MMA) of 2003 and implementing 

regulations at 42 CFR subpart R plan 

sponsors (employers,unions) who offer 

prescription drug coverage to their 

qualified covered retirees are eligible to 

receive a 28% taxfree subsidy for 

allowable drug costs. In order to qualify, 

plan sponsors must submit a complete 

application to CMS with a list of retirees 

for whom it intends to collect the 

subsidy; Frequency: Quarterly, Monthly, 

Annually; Affected Public: Business or 

other for-profit, Not-for-profit 

institutions, Federal, State, local and/or 

tribal Government; Number of 

Respondents: 50,000; Total Annual 

Responses: 50,000; Total Annual Hours: 

2,025,000. 

To obtain copies of the supporting 

statement and any related forms for 

these 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 by the OMB Desk Officer at 

the address below, no later than 5 p.m. 

on December 19, 2005. OMB Human 

Resources and Housing Branch, 

Attention: Carolyn Lovett, CMS Desk 

Officer,New Executive Office Building, 

Room 10235,Washington, DC 20503. 

Dated: November 9, 2005. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 05–22904 Filed 11–17–05; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10173, CMS–

437A and CMS–437B] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Individuals 

Authorized Access to the CMS 

Computer Services; Form Number: 

CMS–10173 (OMB#: 0938–NEW); Use: 

The Centers for Medicare and Medicaid 

Services (CMS) is requesting the Office 

of Management and Budget (OMB) 

approval of the Individuals Authorized 

to Customer Service Application for 

Access to CMS Computer Systems. CMS 

has planned to provide a centralized 

user provisioning and administration 

service that supports the creation, 

deletion, and lifecycle management of 

enterprise identities. This service 

creates accounts, supports Role Based 

Access Control (RBAC), the form flow 

approval process and enterprise identity 

audit and recertification, and provides 

business application integration points. 

An application integration point allows 

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.