28234 Federal Register / Vol. 76, No. 94 / Monday, May 16, 2011 / Notices 

Dated: May 9, 2011. 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–11936 Filed 5–13–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–11–11AC] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 or send 

comments to Daniel Holcomb, CDC 

Reports Clearance Officer, 1600 Clifton 

Road, MS D–74, Atlanta, GA 30333 or 

send an e-mail to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Statements in Support of Application 

of Waiver of Inadmissibility (0920– 

0006, expiration date 12/31/2011)— 

Revision—National Center for Emerging 

and Zoonotic Infectious Diseases 

(NCEZID), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

Section 212(a), (1) of the Immigration 

and Nationality Act states that aliens 

with specific health related conditions 

are ineligible for admission into the 

United States. The Attorney General 

may waive application of this 

inadmissibility on health-related 

grounds if an application for waiver is 

filed and approved by the U.S. 

Citizenship and Immigration Services 

office of the Department of Homeland 

Security having jurisdiction. CDC uses 

this application primarily to collect 

information to establish and maintain 

records of waiver applicants in order to 

notify the U.S. Citizenship and 

Immigration Services when terms, 

conditions and controls imposed by 

waiver are not met. CDC is requesting 

approval from OMB to collect this data 

for another 3 years. 

There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

U.S. medical facility or specialist (Part II) ............ Form CDC 4.422–1 ...... 200 1 10/60 33 

Applicant/Applicant Sponsor (Part III). 

U.S. medical facility or specialist .......................... Form CDC 4.422–1a .... 200 1 20/60 67 

Total ............................................................... ....................................... ........................ ........................ ........................ 100 

Dated: May 9, 2011. 

Dan Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–11935 Filed 5–13–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10380] 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Rate Review 

Grants to States and Territories Cycle I 

and II Funding Opportunity 

Announcement Application and 

Reporting; Use: Under the Section 1003 

of the Affordable Care Act (Section 2794 

of the Public Health Service Act), the 

Secretary, in conjunction with the States 

and territories, is required to establish a 

process for the annual review, beginning 

with the 2010 plan year, of 

unreasonable increases in premiums for 

health insurance coverage. Section 

2794(c) requires the Secretary to 

establish Premium Review Grants to 

States to assist States to implement this 

provision. 

The U.S. Department of Health and 

Human Services (HHS) released the Rate 

Review Grants Cycle I funding 

opportunity twice; first to States (and 

the District of Columbia) in June 2010 

and then to the territories and the five 

States that did not apply during the first 

release, (http://www.hhs.gov/ociio/

initiative/final_premium_review_grant

_solicitation.pdf). The second release 

was due to the decision that the 

territories were subject to provisions of 


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Federal Register / Vol. 76, No. 94 / Monday, May 16, 2011 / Notices 28235 

the ACA and hence eligible for the Rate 

Review Grants. 46 States and 5 U.S. 

territories plus the District of Columbia 

were awarded grants. CCIIO is seeking 

to publish the Cycle II Funding 

Opportunity Announcement and 

associated grantee reporting 

requirements consisting of (4) Quarterly 

reports, rate review transaction data 

(quarterly), (1) annual report per year, 

and (1) final report from all grantees. 

This information collection is required 

for effective monitoring of grantees and 

to fulfill statutory requirements under 

Section 2794(b)(1)(a) that requires 

grantees, as a condition of receiving a 

grant authorized under Section 2794(c), 

to report to The Secretary information 

about premium increases. Form 

Number: CMS–10380 (OCN: 0938– 

1121); Frequency: Annually, On 

Occasion; Affected Public: Public 

Sector: State and Territory 

Governments; Number of Respondents: 

107; Number of Responses: 1,075; Total 

Annual Hours 42,872. (For policy 

questions regarding this collection, 

contact Jacqueline Roche at 301–492– 

4171. 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.gov/

PaperworkReductionActof1995/PRAL/

list.asp#TopOfPage 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 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 July 15, 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: May 10, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–11836 Filed 5–13–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–E–0084 and FDA– 

2009–E–0086] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PRISTIQ; Correction and 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction and 

reopening of the comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting 

notices concerning FDA’s determination 

of the regulatory review period for 

PRISTIQ that appeared in the Federal 

Registers of August 31, 2010 (75 FR 

53314) and September 2, 2010 (75 FR 

53969). The documents omitted docket 

number FDA–2009–E–0086. This 

document corrects those omissions. 

Because the comment period for the 

notices closed on February 28, 2011, 

FDA is reopening the comment period 

to allow interested parties to submit 

comments or petitions to docket number 

FDA–2009–E–0086. 

DATES: Submit either electronic or 

written comments and written petitions 

by June 15, 2011. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: 

I. Correction 

In FR Doc. 2010–21586, appearing on 

page 53314, in the Federal Register of 

Tuesday, August 31, 2010, the following 

correction is made: 

1. On page 53314, in the first column, 

in the heading of the document, 

‘‘[Docket No. FDA–2009–E–0084]’’ is 

corrected to read ‘‘[Docket Nos. FDA– 

2009–E–0084 and FDA–2009–E–0086]’’. 

In FR Doc. C1–2010–21586, appearing 

on page 53969, in the Federal Register 

of Thursday, September 2, 2010, the 

following correction is made: 

2. On page 53969, in the third 

column, in the heading of the 

document, ‘‘[Docket No. FDA–2009–E– 

0084]’’ is corrected to read ‘‘[Docket Nos. 

FDA–2009–E–0084 and FDA–2009–E– 

0086]’’. 

II. Comments and Petitions 

FDA’s notice concerning the Agency’s 

determination of the regulatory review 

period for PRISTIQ (75 FR 53314) 

inadvertently omitted docket number 

FDA–2009–E–0086. Because the period 

for submitting comments and petitions 

closed on February 28, 2011, FDA is 

reopening the comment period to 

provide the opportunity for interested 

parties to submit comments or petitions 

to docket number FDA–2009–E–0086. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is no 

longer necessary to send three copies of 

mailed comments. However, if you 

submit a written petition, you must 

submit three copies of the petition. 

Identify comments with docket number 

FDA–2009–E–0086. Comments and 

petitions that have not been made 

publicly available on regulations.gov 

may be viewed in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 28, 2011. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2011–11903 Filed 5–13–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Neurodifferentiation, 

Plasticity, and Regeneration Study 

Section, June 1, 2011, 8 a.m. to June 2, 

2011, 4 p.m., Westin Alexandria, 400 

Courthouse Square, Alexandria, VA 

22314 which was published in the 

Federal Register on May 9, 2011, 76 FR 

26736–26737. 

The meeting will be held at the Hotel 

Monaco, 480 King Street, Alexandria, 

VA 22314. The meeting dates and time 


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