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

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 outpatientphysical 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 agencyto record data collected during an onsite survey of a provider of outpatientphysical 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 Response s: 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,


### 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 ofthe 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,