Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 14531 

are no Capital Costs to report. There are no Operating or Maintenance Costs to 

report. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE

Data collection activity Type of respondent 

Estimated 

number of 

respondents 

Estimated 

number of 

responses 

per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

requested 

Home Air ........................................... NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

Home Water ...................................... NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

Home Dust ........................................ NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

School and Child Care Facility Air .... NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

School and Child Care Facility Water NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

School and Child Care Facility Dust NCS participants .............................. 4,000 1 1 4,000 

Members of NCS target population 

(not NCS participants).

4,000 1 1 4,000 

Small, focused survey and instrument design and administration.NCS participants .............................. 4,000 2 1 8,000 

Members of NCS target population 

(not NCS participants).

4,000 2 1 8,000 

Health and Social Service Providers 2,000 1 1 2,000 

Community Stakeholders ................. 2,000 1 1 2,000 

Focus groups .................................... NCS participants .............................. 2,000 1 1 2,000 

Members of NCS target population 

(not NCS participants).

2,000 1 1 2,000 

Health and Social Service Providers 2,000 1 1 2,000 

Community Stakeholders ................. 2,000 1 1 2,000 

Cognitive interviews .......................... NCS participants .............................. 500 1 2 1,000 

Members of NCS target population 

(not NCS participants).

500 1 2 1,000 

Total ........................................... ........................................................... 69,000 ........................ ........................ 78,000 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to minimize 

the burden of the collection of 

information on those who are to 

respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Sarah L. 

Glavin, Deputy Director, Office of 

Science Policy, Analysis and 

Communication, National Institute of 

Child Health and Human Development, 

31 Center Drive Room 2A18, Bethesda, 

Maryland 20892, or call non-toll free 

number (301) 496–1877 or Email your 

request, including your address to 

glavins@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: March 6, 2012. 

Sarah L. Glavin, 

Deputy Director, Office of Science Policy, 

Analysis and Communications National 

Institute of Child Health and Human 

Development. 

[FR Doc. 2012–5946 Filed 3–9–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Web-Based Assessment of 

the NHLBI Clinical Studies Support 

Center (CSSC) 

SUMMARY: 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 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH), will publish 

periodic summaries of proposed 

projects to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: Web-Based 

Assessment of the Clinical Studies 

Support Center (CSSC). Type of 

Information Collection Request: New. 


pmangrum on DSK3VPTVN1PROD with NOTICES
14532 Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 

Need and Use of Information Collection: 

Over the past decade Data Safety 

Monitoring Boards (DSMBs), 

Observational Safety Monitoring Boards 

(OSMBs), and Protocol Review 

Committees (PRCs) have become an 

important quality standard in clinical 

trials and research involving human 

subjects. The National Heart, Lung, and 

Blood Institute (NHLBI) alone currently 

has approximately 60 active review 

Committees. These include DSMBs, 

OSMBs, and PRCs which are 

independent groups convened to review 

study protocols developed under NHLBI 

funded Clinical Trial Networks. These 

committees are composed of members 

with expertise in biostatistics, clinical 

trials, bioethics, and other specific 

scientific and research areas. The 

NHLBI is charged with ensuring the 

highest quality of each Institute-funded 

clinical research project and compliance 

with Department of Health and Human 

Services (DHHS)/National Institutes of 

Health (NIH)/NHLBI regulations 

regarding human subject protections 

and safety monitoring. To carry out this 

responsibility, the NHLBI program staff 

instituted a new methodology for 

supporting the administration of 

NHLBI-appointed Committees in 2009. 

The new methodology included the 

establishment of the Clinical Studies 

Support Center (CSSC) under the 

direction of Westat, Inc. The CSSC is a 

pilot program to support the operations 

of NHLBI’s DSMBs, Observational 

OSMBs, and PRCs for the Division of 

Blood Diseases and Resources. Utilizing 

Executive Secretaries to support each 

NHLBI safety monitoring board, the 

CSSC is responsible for documenting 

standardized operating procedures 

related to the administration of 

monitoring committees and the support 

center in a CSSC Manual of Operations 

and Procedures (MOP); coordinating 

meeting space and logistics for inperson meetings, Web conferences, and 

teleconferences; managing distribution 

of adverse event notifications to DSMB 

chairs and members, new protocols, and 

proposed amendments; and providing 

Executive Secretaries who provide 

scientific and administrative support to 

document board recommendations 

related to the safety and efficacy of trial 

interventions and the quality and 

completeness of clinical research study 

data. To move forward with full 

knowledge of current Committee 

operations and to monitor the effect of 

newly established procedures, Westat is 

required, as part of this contract, to 

conduct an assessment of the efficiency 

and effectiveness of NHLBI CSSC 

committee operations. As part of this 

assessment, the NHLBI requires 

feedback and advice regarding the 

support provided by the CSSC for 

monitoring board operations. To this 

end, a Web-based questionnaire will be 

administered to Chairs and members of 

monitoring boards to learn about their 

opinions about specific CSSC activities 

and their satisfaction with the 

performance of CSSC staff. 

Frequency of Response: Once; 

Affected Public: Individuals; Type of 

Respondents: Monitoring board 

members. The annual reporting burden 

is as follows: Estimated Number of 

Respondents: 90; Estimated Number of 

Responses per Respondent: 1; Average 

Burden of Hours per Response: 0.33 and 

Estimated Total Annual Burden Hours 

Requested: 30.36. The annualized cost 

to respondents is estimated at: $3.036 

(based on $100 per hour). There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Table 1–1 and 1–2: Estimate of 

Requested Burden Hours and Dollar 

Value of Burden Hours 

TABLE A.12–1—ESTIMATES OF HOUR BURDEN

Type of respondents Number of 

respondents 

Frequency of 

responses 

Average time 

per response 

Annual hour 

burden 

D/OSMB Chairs ............................................................................................. 10 1 0.33 3 .3 

D/OSMB Members ......................................................................................... 78 1 0.33 25 .74 

Members in two D/OSMB .............................................................................. 2 2 0.33 1 .32 

Total ........................................................................................................ 90 ........................ ........................ 30 .36 

TABLE A.12–2—ANNUALIZED COST TO RESPONDENTS

Type of respondents Number of 

respondents 

Frequency of 

response 

Average time 

per response 

Hourly wage 

rate 

Respondent 

cost 

DSMB Chairs ....................................................................... 10 1 .33 100 330 

DSMB Members ................................................................... 78 1 .33 100 2,574 

Members in two D/OSMB .................................................... 2 2 .33 100 132 

Totals ............................................................................ 90 ........................ ........................ ........................ 3,036 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Erin Smith, 

Contracting Officer’s Technical 

Representative, NHLBI, Room 9149, 

6701 Rockledge Drive, Bethesda, MD 

20892–7950, or call 301–435–0050, or 

Email your request to 

smithee@nhlbi.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 48 / Monday, March 12, 2012 / Notices 14533 

Dated: February 16, 2012. 

Keith Hoots, 

Director, Division of Blood Diseases and 

Resources, National Heart, Lung, and Blood 

Institute, NIH. 

Dated: February 29, 2012. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2012–5918 Filed 3–9–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel 

Basic Research in Calcific Aortic Valve 

Disease. 

Date: April 4, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Crystal Gateway Marriott 1700 

Jefferson Davis Highway Arlington, VA 

22202. 

Contact Person: David A Wilson, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7204, Bethesda, MD 20892–7924, 301–435– 

0299, wilsonda2@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel 

COPD Genetic Epidemiology. 

Date: April 4, 2012. 

Time: 10 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health One 

Democracy Plaza 6701 Democracy Boulevard 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Stephanie J Webb, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7196, Bethesda, MD 20892, 301–435–0291, 

stephanie.webb@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: March 6, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–5928 Filed 3–9–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel; ‘‘BRAD’’. 

Date: March 30, 2012. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852. 

Contact Person: Sherry L. Dupere, Ph.D., 

Director, Division of Scientific Review, 

Division of Scientific Review, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, NIH, 6100 

Executive Blvd., Room 5B01, Bethesda, MD 

20892, 301–451–3415, duperes@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: March 2, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–5932 Filed 3–9–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review: Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Bioengineering Sciences and Technologies: 

Shared Instrument Review. 

Date: March 21–22, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Ping Fan, MD, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5154, 

MSC 7840, Bethesda, MD 20892, 301–408– 

9971, fanp@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA Panel: 

Biophysical and Biomechanical Aspects of 

Embryonic Development. 

Date: March 26–27, 2012. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Elena Smirnova, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5187, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1236, smirnove@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Research in Biomedicine and Agriculture 

Using Agriculturally Important Domestic 

Species. 

Date: March 27, 2012. 

Time: 9 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 


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