8878 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 

room accommodates approximately 240 

people. 

Security Considerations: Due to 

increased security requirements CMS 

has instituted stringent procedures for 

entrance into the building by nongovernment employees. Attendees will 

need to present valid government-issued 

picture identification, and sign-in at the 

security desk upon entering the 

building. Attendees who wish to attend 

the ICD–9–CM C&M meeting on March 

5, 2012, must submit their name and 

organization by February 27, 2012, for 

inclusion on the visitor list. This visitor 

list will be maintained at the front desk 

of the CMS building and used by the 

guards to admit visitors to the meeting. 

Participants who attended previous 

ICD–9–CM C&M meetings will no longer 

be automatically added to the visitor 

list. You must request inclusion of your 

name prior to each meeting you attend. 

Please register to attend the meeting 

on-line at: http://www.cms.hhs.gov/

apps/events/. 

Please contact Mady Hue (410–786– 

4510 or Marilu.hue@cms.hhs.gov), for 

questions about the registration process. 

Purpose: The ICD–9–CM Coordination 

and Maintenance Committee is a public 

forum for the presentation of proposed 

modifications to the International 

Classification of Diseases, NinthRevision, Clinical Modification. 

Matters to be Discussed: Tentative 

agenda items include: 

March 5, 2012 

ICD–9–CM Procedure Topics: 

Administration of Fidaxomicin 

Placement of Modeling Catheter in 

Endovascular Graft Procedure 

Injection or Infusion of Glucarpidase 

ICD–10 Updates: 

ICD–10 MS–DRG Update 

ICD–10 HAC Translation List 

Impact of ICD–10 MS–DRGs 

Implementation 

ICD–10–CM Diagnosis Topics: 

Atypical femoral fracture 

Choking ‘‘game’’ 

Cognitive sequelae of cerebrovascular 

disease 

Family history of SIDS 

Addenda 

Agenda items are subject to change as 

priorities dictate. 

Note: CMS and NCHS will no longer 

provide paper copies of handouts for the 

meeting. Electronic copies of all meeting 

materials will be posted on the CMS and 

NCHS Web sites prior to the meeting at 

http://www.cms.hhs.gov/

ICD9ProviderDiagnosticCodes/03_

meetings.asp#TopOfPage and http:// 

www.cdc.gov/nchs/icd/icd9cm_

maintenance.htm. 

Contact Persons for Additional 

Information: Donna Pickett, Medical 

Systems Administrator, Classifications 

and Public Health Data Standards Staff, 

NCHS, 3311 Toledo Road, Room 2337, 

Hyattsville, Maryland 20782, email 

dfp4@cdc.gov, telephone 301–458–4434 

(diagnosis); Mady Hue, Health 

Insurance Specialist, Division of Acute 

Care, CMS, 7500 Security Boulevard, 

Baltimore, Maryland 21244, email 

marilu.hue@cms.hhs.gov, telephone 

410–786–4510 (procedures). 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention, and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 8, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–3484 Filed 2–14–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee on Immunization 

Practices (ACIP) 

Correction 

This notice was published in the 

Federal Register on February 1, 2012, 

Volume 77, Number 21, Page 5026. The 

matters to be discussed and times 

should read as follows: 

Matters To Be Discussed: The agenda 

will include discussions on: 

meningococcal vaccine, hepatitis B 

vaccine, tetanus, diphtheria, and 

acellular pertussis (Tdap) vaccine, 

influenza, vaccine supply, 13-valent 

pneumococcal conjugate vaccine, and 

measles-mumps-rubella (MMR) vaccine. 

Recommendation vote is scheduled for 

Tdap vaccine. Time will be available for 

public comment. 

Agenda items are subject to change as 

priorities dictate. 

Times and Dates: 

8 a.m.–5 p.m., February 22, 2012. 

8 a.m.–12:30 p.m., February 23, 2012. 

The Meeting is Web cast live via the 

World Wide Web; for instructions and 

more information on ACIP please visit 

the ACIP Web site: http://www.cdc.gov/ 

vaccines/recs/acip/. 

Contact Person for More Information: 

Stephanie B. Thomas, National Center 

for Immunization and Respiratory 

Diseases, CDC, 1600 Clifton Road NE., 

MS–A27, Atlanta, Georgia 30333, 

telephone: (404)639–8836; Email 

ACIP@CDC.GOV. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 8, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–3481 Filed 2–14–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Tracking of Participants in the 

Head Start Impact Study. 

OMB No.: 0970–0229. 

Description: The Administration for 

Children and Families (ACF) within the 

Department of Health and Human 

Services (HHS) will collect follow-up 

information from children and families 

in the Head Start Impact Study. In 

anticipation of conducting a future 

follow-up for the study, ACF will collect 

information necessary to identify 

respondents’ current location and 

follow-up with respondents in the 

future. 

The Head Start Impact Study is a 

longitudinal study involving 4,667 first 

time enrolled three- and four-year-old 

preschool children across 84 nationally 

representative grantee/delegate 

agencies. Participants have been 

randomly assigned to either a Head Start 

group or a control group. Data collection 

for the study began in fall of 2002 and 

has been extended through late spring 

2008 to include the participants’ 3rd 

grade year. Tracking of the participants 

has continued every spring beginning in 

2009 and ending in 2011. 

ACF will continue to examine 

outcomes for the sample through the 

spring of the participant’s 12th grade 

year. To maintain adequate sample size, 

telephone interviews will be conducted 

in order to update the respondent’s 

location and contact information. This 

information will be collected from 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 8879 

parents or guardians in the spring of 

2012, 2013, 2014 2015, and 2016. This 

request package covers three years of 

information collection, from 2012 to 

2014. 

Respondents: The original sample of 

4,667 treatment and control group 

members in the Head Start Impact 

Study, minus 432 families that have 

refused to participate in the study. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Parent Tracking Interview ................................................................................ 4235 1 1⁄3 1412 

Estimated Total Annual Burden 

Hours: 1412. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Planning, Research and Evaluation, 370 

L’Enfant Promenade SW., Washington, 

DC 20447, Attn: OPRE Reports 

Clearance Officer. All requests should 

be identified by the title of the 

information collection. Email address: 

OPREinfocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: February 9, 2012. 

Steven M. Hanmer, 

OPRE Reports Clearance Officer. 

[FR Doc. 2012–3476 Filed 2–14–12; 8:45 am] 

BILLING CODE 4184–22–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0115] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request: Guidance for 

Industry and Food and Drug 

Administration Staff; Class II Special 

Controls Guidance Document: 

Automated Blood Cell Separator 

Device Operating by Centrifugal or 

Filtration Separation Principle 

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 collection of information concerning 

class II special controls for an 

automated blood cell separator device 

operating by centrifugal or filtration 

separation principle. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 16, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7726, Ila.Mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Automated Blood Cell Separator Device 

Operating by Centrifugal or Filtration 

Separation Principle (OMB Control 

Number 0910–0594)—Extension 

Under the Safe Medical Devices Act 

of 1990 (Pub. L. 101–629), FDA may 

establish special controls, including 

performance standards, postmarket 

surveillance, patient registries, 

guidelines, and other appropriate 

actions it believes necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. 

The special control guidance serves to 

support the reclassification from class 

III to class II of the automated blood cell 

separator device operating on a 

centrifugal separation principle 

intended for the routine collection of 

blood and blood components as well as 


sroberts on DSK5SPTVN1PROD with NOTICES