Agency Information Collection Activities: Submission for OMB Review; Comment Request, 20993-20994 [2011-9077]

Download as PDF 20993 Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices 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 mstockstill on DSKH9S0YB1PROD with NOTICES Questionnaires Number of respondents MDP SCD Questionnaire ........................ MDP SCT Questionnaire ........................ Utilization Questionnaire (pre-demonstration) ............... VerDate Mar<15>2010 18:34 Apr 13, 2011 Responses per respondent Total responses Average hours per response Total hour burden Wage rate Total hour cost 140 2 280 .45 126 $20.90 $2633.4 1400 1 1400 .30 420 20.90 8778 900 1 900 .75 675 20.90 14,107.5 Jkt 223001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\14APN1.SGM 14APN1 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 Utilization Questionnaire (post demonstration) ............... SF–36 Health Survey for adults over 18 years of age ........... PedsQL for parents of children & adolescents 18 years or younger ................... PedsQL for children & adolescents 18 years or younger .... The Medical Home Family Index (Health Care Satisfaction) .................... QI Instrument ............. Hemoglobinopathies Emerging Populations Form ............ (Client Family Communication) ............. Total .................... Responses per respondent Wage rate Total hour cost 900 .50 450 20.90 9,405 630 2 1260 .25 315 20.90 6,583.5 270 2 540 .25 135 20.90 2,821.5 225 2 450 .25 112.5 20.90 2,351.25 900 9 2 12 1800 108 .25 450 432 20.90 20.90 9,405 9,028.80 900 2 1800 .20 360 20.90 7,524 6,274 ........................ 9,438 .......................... 3,475.5 ........................ 72,637.95 [FR Doc. 2011–9077 Filed 4–13–11; 8:45 am] BILLING CODE 4165–15–P Health Resources and Services Administration Privacy Act of 1974; Deletion of an Existing System of Records Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA). ACTION: Notice to delete an existing HRSA system of records (SOR). AGENCY: 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. SUMMARY: Jkt 223001 4 59, No. 61 Federal Register pp 6854–6, December 28, 1994. DEPARTMENT OF HEALTH AND HUMAN SERVICES Effective Date: The deletion will be effective on April 14, 2011. Substance Abuse and Mental Health Services Administration DATES: 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. ADDRESSES: 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. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSKH9S0YB1PROD with NOTICES Total hour burden 1 Dated: April 8, 2011. Reva Harris, Acting Director, Division of Policy and Information Coordination. 18:34 Apr 13, 2011 Average hours per response 900 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.’’ VerDate Mar<15>2010 Total responses Dated: March 31, 2011. Mary K. Wakefield, Administrator. [FR Doc. 2011–9112 Filed 4–13–11; 8:45 am] BILLING CODE 4165–15–P PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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, E:\FR\FM\14APN1.SGM 14APN1

Agencies

[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Pages 20993-20994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9077]


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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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Number of     Responses per       Total       Average hours    Total hour                      Total hour
             Questionnaires                 respondents     respondent       responses     per response       burden         Wage rate         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-                      900               1             900             .75             675           20.90        14,107.5
 demonstration).........................

[[Page 20994]]

 
Utilization Questionnaire (post                      900               1             900             .50             450           20.90           9,405
 demonstration).........................
SF-36 Health Survey for adults over 18               630               2            1260             .25             315           20.90         6,583.5
 years of age...........................
PedsQL for parents of children &                     270               2             540             .25             135           20.90         2,821.5
 adolescents 18 years or younger........
PedsQL for children & adolescents 18                 225               2             450             .25           112.5           20.90        2,351.25
 years or younger.......................
The Medical Home Family Index (Health                900               2            1800             .25             450           20.90           9,405
 Care Satisfaction).....................
QI Instrument...........................               9              12             108            4                432           20.90        9,028.80
Hemoglobinopathies Emerging Populations              900               2            1800             .20             360           20.90           7,524
 Form...................................
(Client Family Communication)...........
                                         ---------------------------------------------------------------------------------------------------------------
    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 e-mail 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