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, 


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