Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Notices 19777 

language pathology services requesting 

participation in Medicare/Medicaid 

programs. This form initiates the 

process for obtaining a decision as to 

whether the conditions of participation 

are met as a provider of outpatient 

physical therapy and/or speechlanguage pathology services. It is used 

by the State agencies to enter new 

provider into the ASPEN (Automated 

Survey Process Environment). CMS– 

1893 is used by the State survey agency 

to record data collected during an onsite survey of a provider of outpatient 

physical therapy and/or speechlanguage pathology services, to 

determine compliance with the 

applicable conditions of participation, 

and to report this information to the 

Federal Government. The form is 

primarily a coding worksheet designed 

to facilitate data reduction and retrieval 

into the ASPEN system. The 

information needed to make 

certification decisions is available to 

CMS only through the use of 

information abstracted from the form; 

Form Numbers: CMS–1856 and CMS– 

1893 (OMB#: 0938–0065); Frequency: 

Annually, occasionally; Affected Public: 

Private Sector; Business or other forprofit and not-for-profit institutions; 

Number of Respondents: 2,968; Total 

Annual Responses: 495; Total Annual 

Hours: 866. (For policy questions 

regarding this collection contact Georgia 

Johnson at 410–786–6859. 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 at 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 June 7, 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: April 1, 2011. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2011–8462 Filed 4–7–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10382] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Center for Medicare and 

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 and 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 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. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

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

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. We 

are requesting an emergency review 

because the collection of this 

information is needed before the 

expiration of the normal time limits 

under OMB’s regulations at 5 CFR 

1320.13. This is necessary to ensure 

compliance with an initiative of the 

Administration. We cannot reasonably 

comply with the normal clearance 

procedures due to an unexpected event 

as stated in 5 CFR 1320.13(a)(2)(iii). The 

use of the normal clearance procedures 

would cause a statutory deadline to be 

missed. 

1. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Medicaid 

Emergency Psychiatric Demonstration 

Use: Section 2707 of the Patient 

Protection and Affordable Care Act was 

enacted to implement a demonstration 

to study the effects of allowing 

Medicaid payment for the inpatient 

stabilization of a more serious mental 

health related problem. That is, to 

provide payment for inpatient 

stabilization for psychiatric patients 

aged 21 to 64 who express suicidal or 

homicidal gestures and are considered a 

danger to themselves or others. 

By allowing coverage for inpatient 

admission for emergency psychiatric 

treatment otherwise prohibited by the 

Medicaid institutions for mental 

diseases exclusion, the Demonstration 

may improve access to appropriate 

psychiatric care, improve quality of care 

for Medicaid patients, and encourage 

greater availability of inpatient 

psychiatric beds, thereby reducing the 

necessity of psychiatric boarding. 

As a condition for receiving payment 

under this Demonstration, a State shall 

be responsible for collecting and 

reporting information to the Centers for 

Medicare & Medicaid Services (CMS) 

about the conduct of the Demonstration 

in the State for the purposes of 

providing Federal oversight and the 

evaluation of the Demonstration and 

required to cooperate with the CMS 

evaluation team. CMS is also required to 

submit to Congress, a recommendation 

as to whether the Demonstration project 

should be continued after December 31, 

2013, and expanded on a national basis. 

The statute requires that a State 

seeking to participate in this 

Demonstration project shall submit an 

application that includes such 

information, provisions, and assurances 

necessary to assess the State’s ability to 

conduct the Demonstration as compared 

with other State applicants. The State 

Medical Director will submit the 

Demonstration application proposal. 

Form Number: CMS–10382 (OMB#: 

0938–New); Frequency: Once; Affected 

Public: Individuals or Households; 

Number of Respondents: 44; Total 

Annual Responses: 54; Total Annual 

Hours: 2,106. (For policy questions 

regarding this collection contact Diana 

Ayres 410–786–7203. For all other 

issues call 410–786–1326.) 

CMS is requesting OMB review and 

approval of this collection by May 9, 


srobinson on DSKHWCL6B1PROD with NOTICES
19778 Federal Register / Vol. 76, No. 68 / Friday, April 8, 2011 / Notices 

2011, with a 180-day approval period. 

Written comments and 

recommendations will be considered 

from the public if received by the 

individuals designated below by May 4, 

2011. 

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. 

Interested persons are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. However, as 

noted above, comments on these 

information collection and 

recordkeeping requirements must be 

mailed and/or faxed to the designees 

referenced below by May 4, 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. 

3. By Facsimile or E-mail to OMB. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer. Fax Number: (202) 395–6974. Email: OIRA_submission@omb.eop.gov. 

Dated: April 1, 2011. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2011–8459 Filed 4–7–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0544] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Application for Participation in the 

Medical Device Fellowship Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Application for Participation in the 

Medical Device Fellowship Program’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@FDA.HHS.GOV. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of January 27, 2011 (76 

FR 4913), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0551. The 

approval expires on March 31, 2014. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: April 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8369 Filed 4–7–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program: Statement of Reasons for 

Not Conducting Rule-Making 

Proceedings 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: In accordance with section 

2114(c)(2)(B) of the Public Health 

Service Act, notice is hereby given of 

the reasons for not conducting a rulemaking proceeding for adding GuillainBarre ́ Syndrome (GBS) to the Vaccine 

Injury Table at this time. 

DATES: Written comments are not being 

solicited. 

FOR FURTHER INFORMATION CONTACT: 

Geoffrey Evans, M.D., Director, Division 

of Vaccine Injury Compensation, 

Healthcare Systems Bureau, Health 

Resources and Services Administration 

(HRSA), Room 11C–26, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

Maryland 20857; telephone number 

(301) 443–6593. 

SUPPLEMENTARY INFORMATION: The 

National Childhood Vaccine Injury Act 

of 1986, title III of Public Law 99–660 

(42 U.S.C. 300aa–10 et seq.) established 

the National Vaccine Injury 

Compensation Program (VICP) for 

persons found to be injured by vaccines. 

Under this Federal program, petitions 

for compensation are filed with the 

United States Court of Federal Claims 

(Court). The Court, acting through 

special masters, makes findings as to 

eligibility for, and amount of, 

compensation. In order to gain 

entitlement to compensation under title 

XXI of the Public Health Service (PHS) 

Act for a covered vaccine, a petitioner 

must establish a vaccine-related injury 

or death, either by proving that the first 

symptom of an injury/condition, as 

defined by the Qualifications and Aids 

to Interpretation, occurred within the 

time period listed on the Vaccine Injury 

Table (Table), and therefore presumed 

to be caused by a vaccine (unless 

another cause is found), or by proof of 

vaccine causation, if the injury/ 

condition is not on the Table or did not 

occur within the time period specified 

on the Table. 

The statute authorizing the VICP 

provides for the inclusion of additional 

vaccines in the VICP when they are 

recommended by the Centers for Disease 

Control and Prevention (CDC) for 

routine administration to children. See 

section 2114(e)(2) of the PHS Act, 42 

U.S.C. 300aa–14(e)(2). Consistent with 

section 13632(a)(3) of Public Law 103– 

66, the regulations governing the VICP 

provide that such vaccines will be 

included in the Table as of the effective 

date of an excise tax to provide funds 

for the payment of compensation with 

respect to such vaccines. 42 CFR 

100.3(c)(5). The statute authorizing the 

VICP also authorizes the Secretary to 

create and modify a list of injuries, 


srobinson on DSKHWCL6B1PROD with NOTICES