Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 75475 

contact: nationalconversation@cdc.gov 

or Julie Fishman at 770–488–0629. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–30165 Filed 12–2–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–437] 

Agency Information Collection 

Activities: Proposed Collection; 

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) 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: Extension of currently 

approved collection; Title of 

Information Collection: Psychiatric Unit 

Criteria Work Sheet and Supporting 

Regulations 412.25 and 412.27; Use: 

Certain hospital units are excluded from 

the Medicare Prospective Payment 

System (PPS). The exclusion of units is 

not optional on the part of the provider 

but is required by section 1886(d)(1)(B) 

of the Social Security Act. That section 

excludes psychiatric hospitals, 

rehabilitation hospitals, hospitals whose 

inpatients are predominantly 

individuals under 18 years of age 

(children’s hospitals), and psychiatric 

and rehabilitation units which are a 

distinct part of a hospital. 

CMS proposes to continue the current 

process of performing initial 

verifications and annual reverifications 

to determine that psychiatric units 

continue to comply with the regulatory 

criteria at 42 CFR 412.25 and 42 CFR 

412.27 of the PPS regulations. These 

regulations state the criteria that distinct 

part units must meet for exclusion. 

If, as a result of the regular survey 

process a hospital is certified as a 

psychiatric hospital by the State survey 

agency (SA), then it automatically 

satisfies the regulatory criteria for 

exclusion. Thus, no additional 

verification is required for psychiatric 

hospitals. Some verification is needed, 

however, to ensure that other types of 

hospitals and units meet the criteria for 

exclusion. 

Consequently, CMS instructed the 

Fiscal Intermediaries (FIs) and SAs to 

perform certain verification activities, 

beginning in October 1983 when PPS 

was implemented. CMS originally 

developed the CMS–437 as SA 

Worksheet for verifying exclusions from 

PPS for psychiatric units. 

Since April 9, 1994, PPS-excluded 

psychiatric units already excluded from 

the PPS have met CMS’s annual 

requirement for PPS-exclusion by selfattesting that they remain in compliance 

with the PPS exclusion criteria. Under 

the current procedure, all psychiatric 

units applying for first-time exclusion 

are surveyed by the SAs. The SAs also 

perform surveys to investigate 

complaint allegations and conduct 

annual sample reverification surveys on 

5 percent of all psychiatric units. 

The aforementioned exclusions 

continue to exist and thus CMS 

proposes to continue to use the Criteria 

Worksheet, Forms CMS–437 for 

verifying first-time exclusions from the 

PPS, for complaint surveys, for its 

annual 5 percent validation sample, and 

for facility self-attestation. These forms 

are related to the survey and 

certification and Medicare approval of 

the PPS-excluded units. Form Number: 

CMS–437 (OMB#: 0938–0358); 

Frequency: Annually; Affected Public: 

Private sector businesses or other forprofits; Number of Respondents: 1,333; 

Total Annual Responses: 1,333; Total 

Annual Hours: 333. (For policy 

questions regarding this collection 

contact Kelley Leonette at 410–786– 

6664. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

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. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by February 1, 2011: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: November 24, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–30367 Filed 12–2–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0597] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the burden hours associated with 

indexing of legally marketed 

unapproved new animal drugs for minor 

species. 

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