Federal Register / Vol. 73, No. 154 / Friday, August 8, 2008 / Notices 46301 

Dated: July 31, 2008. 

William H. Gimson, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E8–18177 Filed 8–7–08; 8:45 am] 

BILLING CODE 4160–18–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–138, CMS–

10147, CMS–10146, CMS–10064, and CMS–

10225] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Agency: Centers for Medicare & 

Medicaid Services, HHS. 

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), Department of Health 

and Human Services, 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 function; 

(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: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Geographic Classification Review Board 

(MGCRB) Procedures and Criteria and 

Supporting Regulations in 42 CFR, 

Section 412.256 & 412.230; Use: Section 

1886(d)(10) of the Social Security Act 

established the MGCRB, an entity that 

has the authority to accept short-term 

hospital inpatient prospective payment 

system (IPPS) hospital applications 

requesting geographic reclassification 

for wage index or standardized payment 

amounts and to issue decisions on these 

requests. Since it is important to ensure 

the accuracy of the MGCRB decisions 

and remain apprised of potential 

payment impacts, the regulations note 

that CMS should also receive a copy of 

any hospital’s application to the 

MGCRB. The information submitted by 

the hospitals is used by CMS staff to 

determine the validity of the hospitals’

requests and the discretion used by the 

MGCRB in reviewing and making 

decisions regarding hospitals’ requests 

for geographic reclassification. Since 

CMS wrote the guidelines for the 

MGCRB, it is essential that CMS staff 

monitor this process. Form Number: 

CMS–R–138 (OMB# 0938–0573); 

Frequency: Yearly; Affected Public: 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 300; Total Annual 

Responses: 300; Total Annual Hours: 

300. 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Prescription Drug Coverage and Your 

Rights; Use: Section 42 CFR 423.562, 

requires each Part D plan sponsor to 

arrange with its network pharmacies to 

post or distribute the Medicare 

Prescription Drug Coverage and Your 

Rights notice to Part D plan enrollees at 

each pharmacy visit when the enrollee 

disagrees with the information provided 

by the pharmacist. The purpose of this 

notice is to provide enrollees with 

information about how to contact their 

Part D plans to request a coverage 

determination, including a request for 

an exception to the Part D plan’s 

formulary. Form Number: CMS 10147 

(OMB# 0938–0975); Frequency: Daily; 

Affected Public: Business or other forprofits; Number of Respondents: 40,000; 

Total Annual Responses: 30,000,000; 

Total Annual Hours: 500,000. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Notice of Denial 

of Medicare Prescription Drug Coverage; 

Use: Section 1860D–4(g)(1) of the Social 

Security Act, requires Part D plan 

sponsors that deny prescription drug 

coverage to provide a written notice of 

the denial to the enrollee. The written 

notice must include a statement, in clear 

language, of the reasons for the denial 

and a description of the appeals process. 

Form Number: CMS 10146 (OMB# 

0938–0976); Frequency: Daily; Affected 

Public: Business or other for-profits; 

Number of Respondents: 758; Total 

Annual Responses: 290,344; Total 

Annual Hours: 145,172. 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Minimum Data 

Set (MDS) for Swing Bed Hospitals and 

Supporting Regulations in 42 CFR 

413.114(a)(2) and 413.343(a); Use: 

Exercising CMS’ authority under section 

1888(e)(7) of the Social Security Act to 

determine the most appropriate manner 

in which to implement the Skilled 

Nursing Facility Prospective Payment 

System (SNF PPS) for swing bed 

hospitals, CMS designed a 2-page MDS 

instrument for use by swing bed 

hospitals that includes all resident 

assessment data needed to reimburse 

swing bed hospitals for SNF-level care 

furnished to Medicare beneficiaries and 

to provide CMS with the basic 

demographic and utilization data for 

future planning and analysis. Form 

Number: CMS–10064 (OMB# 0938–

0872); Frequency: Occasionally; 

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

State, Local, or Tribal Governments; 

Number of Respondents: 481; Total 

Annual Responses: 50,505; Total 

Annual Hours: 328,283. 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Disclosures to 

Patients by Certain Hospitals and 

Critical Access Hospitals and 

Supporting Regulations in 42 CFR 

489.20; Form Number: CMS–10225 

(OMB#: 0938–1035); Use: This 

information request relates to proposed 

required third party disclosures by 

certain Medicare-participating hospitals 

and critical access hospitals (CAHs) to 

their patients. The policy is contained 

in the FY 2009 Inpatient Prospective 

Payment System Final Rule. Because 

this information request is closely 

related to the previously approved 

collection burden under 0938–01034, 

we have included a discussion of both 

the approved provisions and the new 

provisions in the supporting statement 

document. 

In addition to the two existing 

collections previously approved under 

0938–1034, we are revising § 489.3 to 

define a physician-owned hospital as a 

hospital in which a physician, or an 

immediate family member of a 

physician has an ownership or 

investment interest in the hospital. 

Because of this change to the definition 

of a physician-owned hospital, new 

§ 489.20(u)(1) will require that hospitals 

with ownership or investment interests 

by a physician or immediate family 

member disclose this information to all 

their patients. Additionally, we revised 

§ 489.20(u) by creating § 489.20(u)(1) 

that requires any physician-owned 

hospital to furnish patients with written 

notice that the hospital is physicianowned and provide the list of physician 

owners (including immediate family 

members) to the patient at the time the 

patient or someone on the patient’s 

behalf requests it. 


pwalker on PROD1PC71 with NOTICES
46302 Federal Register / Vol. 73, No. 154 / Friday, August 8, 2008 / Notices 

We also require three new collections 

which are the primary focus of this 

supporting statement. First, we have 

added new § 489.20(u)(2) to require a 

hospital to require all physicians who 

are members of the hospital’s medical 

staff to agree, as a condition of 

continued medical staff membership or 

admitting privileges, to disclose in 

writing to all patients they refer to the 

hospital any ownership or investment 

interest in the hospital held by 

themselves or by an immediate family 

member. The burden associated with 

this requirement is two-fold and 

pertains to both hospitals and 

physicians. First, hospitals are required 

to update by-laws and policies and 

procedures to reflect that as a condition 

of medical staff membership or 

admitting privileges, physicians must 

agree to disclose ownership or 

investment interests to patient. In 

addition, physicians are required to 

develop disclosure notices, distribute 

them to patients and maintain these 

disclosures in the patients’ medical 

records. 

Finally, we are including new 

language under § 489.20(v) to provide 

for an exception to the disclosure 

requirements for a physician-owned 

hospital that does not have at least one 

referring physician who has an 

ownership or investment interest in the 

hospital (or who has an immediate 

family member with an ownership or 

investment interest in the hospital), 

provided that the hospital attests, in 

writing, to that effect and maintains 

such attestation in its files. The burden 

associated with this requirement is 

limited to those physician-owned 

hospitals that do not have physician 

owners who refer patients to the 

hospital. 

The intent of the disclosures is to 

increase the transparency of the 

hospital’s ownership and operations to 

patients as they make decisions about 

receiving care at the hospital. 

Frequency: Reporting—Occasionally; 

Affected Public: Business or other forprofit; Number of Respondents: 2,697; 

Total Annual Responses: 49,735,828; 

Total Annual Hours: 840,318. 

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/ 

PaperworkReductionActof1995, or email 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 September 8, 2008. 

OMB Human Resources and Housing 

Branch, Attention: OMB Desk Officer, 

New Executive Office Building, Room 

10235, Washington, DC 20503, Fax 

Number: (202) 395–6974. 

Dated: July 31, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E8–18361 Filed 8–7–08; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0429] 

Food Labeling; Current Trends in the 

Use of Allergen Advisory Labeling: Its 

Use, Effectiveness, and Consumer 

Perception; Public Hearing; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing on the use of advisory 

labeling of allergens in foods. FDA is 

developing a long-term strategy to assist 

manufacturers in using allergen 

advisory labeling that is truthful and not 

misleading, conveys a clear and uniform 

message, and adequately informs foodallergic consumers and their caregivers. 

To that end, FDA is soliciting comments 

and information to assist the agency in 

determining how manufacturers 

currently use advisory labeling, how 

consumers interpret different advisory 

labeling statements, and what wording 

is likely to be most effective in 

communicating to consumers the 

likelihood that an allergen may be 

present in a food. The agency is also 

interested in receiving comments about 

whether consumers find advisory 

labeling helpful for making food 

purchasing decisions. This public 

hearing is the first step in closing 

existing knowledge gaps in developing 

our long-term strategy. 

DATES: The public hearing will be held 

on September 16, 2008, from 9 a.m. to 

4:30 p.m. The closing date for 

registration is September 8, 2008. See 

section V of this document for other 

dates associated with participation in 

the hearing. Submit written or 

electronic comments (i.e., submissions 

other than notices of participation and 

written material associated with an oral 

presentation) by January 14, 2009. The 

administrative record of the hearing will 

remain open until January 14, 2009. 

ADDRESSES: Public hearing. The public 

hearing will be held at the Harvey W. 

Wiley Federal Building, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, (Metro stop: College Park on the 

Green Line). 

Registration. Submit electronic 

notices of participation for the hearing 

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

register.html. We encourage you to use 

this method of registration, if possible. 

Submit written notices of participation 

by mail, fax, or e-mail to Isabelle Howes, 

U.S. Department of Agriculture 

Graduate School, 600 Maryland Ave., 

SW., suite 330, Washington, DC 20024–

2520, FAX: 202–479–6801, or e-mail: 

Isabelle_Howes@grad.usda.gov. You 

may also submit oral notices of 

participation by phone to Isabelle 

Howes, U.S. Department of Agriculture 

Graduate School (see FOR FURTHER

INFORMATION CONTACT). 

Written material associated with an 

oral presentation. Submit written 

material associated with an oral 

presentation by mail, fax, or e-mail to 

Isabelle Howes. 

Comments. Submit written comments 

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.regulations.gov. For additional 

information on submitting comments, 

see section VI in this document. 

FOR FURTHER INFORMATION CONTACT: 

For questions about registration or 

written material associated with an 

oral presentation, or to register 

orally: Isabelle Howes, 202–314–

4713. 

For all other questions about the 

hearing or if you need parking or 

special accommodations due to a 

disability: Juanita Yates, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 

301–436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Food allergies affect approximately 

two percent of adults and about five 


pwalker on PROD1PC71 with NOTICES