Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices 20993 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on low level laser 

systems for aesthetic use. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. To 

receive ‘‘Class II Special Controls 

Guidance Document: Low Level Laser 

System for Aesthetic Use,’’ you may 

either send an e-mail request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1735 to identify the guidance 

you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, subpart E, have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; and the collections 

of information in 21 CFR 801 have been 

approved under OMB control number 

0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8945 Filed 4–13–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Sickle Cell Disease 

Program Evaluations and Quality 

Improvement Activities—[NEW] 

The Sickle Cell Disease and Newborn 

Screening Program (SCDNBSP) and the 

Sickle Cell Disease Treatment 

Demonstration Program (SCDTDP) are 

both administered by the Genetic 

Services Branch (GSB) of the Division of 

Services for Children with Special 

Health Needs in the Health Resources 

and Services Administration’s (HRSA) 

Maternal and Child Health Bureau 

(MCHB). The SCDTDP is comprised of 

geographically distributed regional 

networks that provide coordinated, 

comprehensive, culturally competent, 

and family-centered care to families 

with sickle cell disease and a national 

coordinating center to support grantee 

activities. The SCDTDP is designed to 

improve access to services for 

individuals with sickle cell disease, 

improve/expand patient and provider 

education, and improve/expand the 

continuity and coordination of service 

delivery for individuals with sickle cell 

disease and carriers of the sickle cell 

gene mutation. The SCDNBSP is 

comprised of several national funded 

community-based sickle cell disease 

networks located in the U.S. and the 

National Coordinating and Evaluation 

Center. The community-based sickle 

cell disease networks partner with State 

newborn screening programs, 

comprehensive sickle cell treatment 

centers, and health care professionals to 

provide support to infants screened 

positive for sickle cell disease, carriers 

of the sickle cell gene mutation and 

their families. 

HRSA seeks to conduct two 

evaluations (SCDTDP evaluation 

previously approved by OMB) and a 

quality improvement project, the 

purpose of which are to assess the 

service delivery processes and outcomes 

resulting from the systems of care 

delivered by the SCDNBSP and SCDTDP 

networks to individuals affected by 

sickle cell disease who present at their 

sites for care. The clients of the three 

programs will be the respondents for 

this data collection activity. 

The annual estimate of burden for 

both the SCDNBSP and the SCDTDP 

evaluations and quality improvement 

effort is as follows: 

ESTIMATED HOUR AND COST BURDEN OF THE DATA COLLECTION

Questionnaires Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average hours 

per response 

Total hour 

burden Wage rate Total hour cost 

MDP SCD Questionnaire ........................ 140 2 280 .45 126 $20.90 $2633.4 

MDP SCT Questionnaire ........................ 1400 1 1400 .30 420 20.90 8778 

Utilization Questionnaire (pre-demonstration) ............... 900 1 900 .75 675 20.90 14,107.5 

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20994 Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices 

ESTIMATED HOUR AND COST BURDEN OF THE DATA COLLECTION—Continued 

Questionnaires Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Average hours 

per response 

Total hour 

burden Wage rate Total hour cost 

Utilization Questionnaire (post demonstration) ............... 900 1 900 .50 450 20.90 9,405 

SF–36 Health Survey 

for adults over 18 

years of age ........... 630 2 1260 .25 315 20.90 6,583.5 

PedsQL for parents of 

children & adolescents 18 years or 

younger ................... 270 2 540 .25 135 20.90 2,821.5 

PedsQL for children & 

adolescents 18 

years or younger .... 225 2 450 .25 112.5 20.90 2,351.25 

The Medical Home 

Family Index 

(Health Care Satisfaction) .................... 900 2 1800 .25 450 20.90 9,405 

QI Instrument ............. 9 12 108 4 432 20.90 9,028.80 

Hemoglobinopathies 

Emerging Populations Form ............

(Client Family Communication) ............. 900 2 1800 .20 360 20.90 7,524 

Total .................... 6,274 ........................ 9,438 .......................... 3,475.5 ........................ 72,637.95 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: April 8, 2011. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2011–9077 Filed 4–13–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Privacy Act of 1974; Deletion of an 

Existing System of Records 

AGENCY: Department of Health and 

Human Services (HHS), Health 

Resources and Services Administration 

(HRSA). 

ACTION: Notice to delete an existing 

HRSA system of records (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

HRSA is deleting an existing system of 

records titled Record of Patient’s 

Personal Valuables and Monies, HRSA 

SOR #09–15–0002, established at Vol. 

59, No. 61 Federal Register pp 6854–6, 

December 28, 1994. 

DATES: Effective Date: The deletion will 

be effective on April 14, 2011. 

ADDRESSES: The public should address 

comments to Associate Administrator, 

Health Resources and Services 

Administration, 5600 Fishers Lane, 

Room 17–105, Rockville, Maryland 

20857, Telephone number 301–594– 

4110. Comments received will be 

available for review at this location, by 

appointment, during regular business 

hours, Monday through Friday from 

9 a.m. to 3 p.m., Eastern Time Zone. 

SUPPLEMENTARY INFORMATION: HRSA’s 

Bureau of Primary Health Care’s 

National Hansen’s Disease Program 

(NHDP) located in Baton Rouge, 

Louisiana, formerly leased hospital 

space where the elderly Hansen’s 

disease resident patients resided. The 

purpose of this System of Records was 

to provide for the safekeeping of those 

residents’ valuables as needed. In 

September 2009, when the hospital 

lease expired, those Hansen’s disease 

residents were relocated to a nursing 

home facility; therefore, this system of 

records is no longer required. 

Dated: March 31, 2011. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. 2011–9112 Filed 4–13–11; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Prevention; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given of the Web 

conference meeting of the Substance 

Abuse and Mental Health Services 

Administration’s (SAMHSA) Center for 

Substance Abuse Prevention (CSAP) 

Drug Testing Advisory Board (DTAB) on 

May 3 and 4, 2011. 

A portion of the meeting from 10 a.m. 

to 5 p.m. EDT on May 3 will be open 

to the public and will include the 

Federal drug testing updates from the 

Department of Transportation, the 

Department of Defense, the Nuclear 

Regulatory Commission, and the Federal 

Drug-Free Workplace Programs; updates 

on the electronic custody and control 

form and the medical review officer 

certification under the Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs; and updates on oral 

fluid as a potential alternative specimen 

for Federal Workplace Drug Testing 

Programs. 

The public is invited to attend the 

open session in person or to listen via 

teleconference. Due to the limited 

seating space and call-in capacity, 

registration is requested. Public 

comments are welcome. To register, 

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