73112 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

Customer Number of respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

FY 2011 

Clinical Center Patients ................................................................................. 5000 1 .5 2500 

Family Members of Patients .......................................................................... 3000 1 .5 1500 

Visitors to the Clinical Center ........................................................................ 1500 1 .17 255 

NIH Intramural Collaborators ......................................................................... 1500 1 .25 375 

Vendors and Collaborating Commercial Enterprises .................................... 1000 1 .25 250 

Professionals and Organizations Referring Patients ..................................... 3000 1 .33 1000 

Regulators ...................................................................................................... 30 1 .33 10 

Volunteers ...................................................................................................... 275 1 .33 92 

Total ........................................................................................................ 15,305 ........................ .......................... 5,982 

FY 2012 

Clinical Center Patients ................................................................................. 5000 1 .5 2500 

Family Members of Patients .......................................................................... 2000 1 .5 1000 

Visitors to the Clinical Center ........................................................................ 1000 1 .17 170 

NIH Intramural Collaborators ......................................................................... 1000 1 .17 170 

Vendors and Collaborating Commercial Enterprises .................................... 2500 1 .25 625 

Professionals and Organizations Referring Patients ..................................... 3000 1 .33 1000 

Regulators ...................................................................................................... 25 1 .25 6 

Volunteers ...................................................................................................... 300 1 .25 75 

Total ........................................................................................................ 14,825 ........................ .......................... 5,546 

Estimated costs to the respondents 

consists of their time; time is estimated 

using a rate of $10.00 per hour for 

patients and the public; $30.00 for 

vendors, regulators, organizations and 

$55.00 for health care professionals. The 

estimated annual costs to respondents 

for each year for which the generic 

clearance is requested is $127,885 for 

2010, $126,895 for 2011, and $120,730 

for 2012. Estimated Capital Costs are 

$7,000. Estimated Operating and 

Maintenance costs are $75,000. 

Requests 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 functions of the 

Clinical Center and the agency, 

including whether the information shall 

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 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 those who are to respond, including 

the use of automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. 

David K. Henderson, Deputy Director 

for Clinical Care, National Institutes of 

Health Clinical Center, Building 10, 

Room 6–1480, 10 Center Drive, 

Bethesda, Maryland 20892, or call nontoll free: 301–496–3515, or e-mail your 

request or comments, including your 

address to: dkh@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: November 22, 2010. 

David K. Henderson, 

Deputy Director for Clinical Care, CC, 

National Institutes of Health. 

[FR Doc. 2010–29953 Filed 11–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

HEALTH AND HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notification of 

Request for Emergency Clearance; 

GuLF Study: Gulf Long-term Follow-up 

Study for Oil Spill Clean-Up Workers 

and Volunteers 

In accordance with Section 3507(j) of 

the Paperwork Reduction Act of 1995, 

the National Institutes of Health (NIH) 

hereby publishes notification of request 

for Emergency Clearance for the 

information collection related to the 

GuLF Study: Gulf Long-term Follow-up 

Study for Oil Spill Clean-Up Workers 

and Volunteers. 

This information collection is 

essential to the mission of NIEHS (42 

U.S.C. 285l), which is to conduct and 

support research, training, health 

information dissemination, and other 

programs with respect to factors in the 

environment that affect human health, 

directly or indirectly. Through this 

mission, the NIEHS has a mandate to 

study the environmental impact on 

individuals of natural and man-made 

catastrophes and the long term health 

effects of these incidents. The 

Deepwater Horizon disaster, with its 

release of approximately 5 million 

barrels (∼ 680,000 tons) of crude oil into 

the Gulf of Mexico, represents the 

largest oil spill in U.S. history. Given 

the magnitude of this spill and the 

scope of the potential exposures—over 

100,000 persons have completed safety 

training in preparation for participation 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 73113 

in clean-up activities related to the 

spill—study of the human health effects 

of this spill is urgently needed to 

monitor gulf clean-up workers and to 

understand the adverse consequences of 

oil spills in general. 

Close ongoing community 

engagement will enhance scientific 

validity of the study, make it more 

broadly relevant from a public health 

perspective, and expand its benefits to 

the affected communities. We have 

established contacts with community 

organizations, representative worker 

organizations, advocacy groups, and 

State and local governments to identify 

the primary health issues of concern 

locally and to discuss study 

implementation issues across the five 

State area. Further, we will identify 

Community Outreach Coordinators to 

organize and implement outreach 

activities in each of the Gulf States. In 

addition to the continuing efforts with 

public health and community group 

representatives, we have been 

conducting and will continue webinars, 

dockside chats, and phone and inperson briefings with key stakeholder 

groups and health departments. 

NIEHS cannot reasonably comply 

with the normal clearance procedures to 

initiate this information collection, 

because the use of normal procedures 

will delay the collection and hinder the 

agency in accomplishing its mission, to 

the detriment of the public good. 

Compelling reason exists to collect the 

required information at the earliest 

opportunity in order to capture 

information that may be lost with 

passage of time and to initiate contact 

with the workers and populations 

exposed to the effects of the spill. 

The information to be obtained by this 

survey will provide the NIEHS, the U.S. 

government and the private sector with 

information on potential short- and 

long-term human health effects 

associated with clean-up and disposal 

activities surrounding the Deepwater 

Horizon oil spill in the Gulf of Mexico. 

Health areas of interest include, but are 

not limited to, respiratory, 

cardiovascular, hematologic, 

dermatologic, neurologic, cancer, 

reproductive, mental health, substance 

abuse, immunologic, hepatic, and renal 

effects. The study will investigate 

biomarkers of potentially adverse 

biological effect, including DNA 

damage, aberrant epigenetic profiles, 

and alterations in gene expression, some 

of which have been observed in 

previous studies of oil spill clean-up 

workers. The study will create a 

resource for additional collaborative 

research on specific scientific 

hypotheses or on subgroups of interest, 

and work with external scientists to 

facilitate nested sub-studies within the 

existing cohort to examine outcomes 

and exposure subgroups of interest; and 

create a resource to better understand 

the short and long-term human health 

effects of oil and oil dispersants in the 

environment. 

Proposed Collection: Title: GuLF 

Study: Gulf Long-term Follow-up Study 

for Oil Spill Clean-Up Workers and 

Volunteers. Type of Information 

Collection Request: Emergency. Need 

and Use of Information Collection: The 

purpose of the GuLF Study is to 

investigate potential short- and longterm health effects associated with oil 

spill clean-up activities and exposures 

surrounding the Deepwater Horizon 

disaster; and to create a resource for 

additional collaborative research on 

focused hypotheses or subgroups. Over 

55,000 persons participating in oil-spill 

clean-up activities have been exposed to 

a range of known and suspected toxins 

in crude oil, burning oil, and 

dispersants, to excessive heat, and 

possibly to stress due to widespread 

economic and lifestyle disruption. 

Exposures range from negligible to 

potentially significant, however, 

potential long-term human health 

consequences are largely unknown due 

to insufficient research in this area. 

Participants will be recruited from 

across job/exposure groups of primarily 

English, Spanish, or Vietnamese 

speaking adults (accommodations for 

other languages developed as 

appropriate) who performed oil-spill 

clean-up-related work (‘‘exposed’’) and 

similar persons who did not 

(‘‘unexposed’’ controls), and followed in 

either an Active Follow-up Cohort 

(N∼27,000) or a Passive Follow-up 

Cohort (N∼28,000). Exposures will be 

estimated using detailed job-exposure 

matrices developed from data from 

monitoring performed by different 

agencies and organizations during the 

crisis, information obtained by 

interview, and the available scientific 

literature. We will investigate acute 

health effects among all cohort members 

via self-report from the enrollment 

interview, and via clinical measures and 

biological samples from Active Followup Cohort members only. All cohort 

members will be followed for 

development of a range of health 

outcomes through record linkage (e.g., 

cancer, mortality) and possibly through 

linkage with routinely collected health 

surveillance data (collected by health 

departments and the CDC) or with 

electronic medical records. Recruitment 

of subjects should begin in late 2010, 

with telephone interviews and the 

baseline home visits conducted within 

18 months. 

Frequency of Response: Participation 

will include one enrollment telephone 

interview (0.5 hr); collection of 

biological and environmental samples, 

basic clinical measurements, and GPS 

coordinates (2.75 hr) from the Active 

Follow-up Cohort only; annual contact 

information update (0.25; Active and 

Passive) or biennial follow-up telephone 

or Web interviews (0.5 hr; Active only) 

for 10 years or more. We also anticipate 

screening 25,000 ineligible respondents. 

Affected Public: Individuals or 

households. Type of Respondents: 

Workers involved in Deepwater Horizon 

disaster clean-up, and similar 

individuals not involved in clean-up 

effort. The annual reporting burden is as 

follows: Estimated Number of 

Respondents: Active Follow-up Cohort 

(N∼27,000) and Passive Follow-up 

Cohort (N∼28,000). Estimated Number 

of Responses per Respondent: See table. 

Activity (3-yrs) 

Estimated 

number of respondents 

Estimated responses per 

respondent 

Burden hours 

per response 

Total burden 

hours per respondent 

Estimated total 

burden hours 

Ineligible respondents .......................................................... 25,000 1 0.25 0.25 6,250 

Enrollment interview (All) ..................................................... 55,000 1 0.50 0.50 27,500 

Home Visit (Active) .............................................................. 27,000 1 2.75 2.75 74,250 

Annual Contact Info Update (Passive) ................................ 28,000 3 0.25 0.75 21,000 

Annual Contact Info Update (Active) ................................... 27,000 2 0.25 0.50 13,500 

Biennial interview (Active) .................................................... 27,000 1 0.50 0.50 13,500 

Passive Cohort Total responses & hrs ......................... 4 1.25 

Active Cohort Total responses & hrs ........................... 5 4.25 

Total responses & avg hrs per response .............. 9 0.58 156,000 

Average per year ............................................ 52,000 

mstockstill on DSKH9S0YB1PROD with NOTICES

73114 Federal Register / Vol. 75, No. 228 / Monday, November 29, 2010 / Notices 

Average Burden Hours per Response: 

0.58 hour; and Estimated Total Burden 

Hours Requested: 156,000 (over 3 years). 

The average annual burden hours 

requested is 52,000. The annualized cost 

to respondents is estimated at $11.60 

(assuming $20 hourly wage × 0.58 hour). 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. 

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. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, New Executive 

Office Building, Room 10235, 

Washington, DC 20503, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. Dale 

P. Sandler, Chief, Epidemiology Branch, 

NIEHS, Rall Building A3–05, PO Box 

12233, Research Triangle Park, NC 

27709; non-toll-free number 919–541– 

4668 or E-mail sandler@niehs.nih.gov. 

Include your address. 

By publication of this request of this 

request for emergency review, the 

NIEHS is requesting the approval for 

this collection. In view of the urgent 

public priority to initiate the study at 

the earliest opportunity in the wake of 

a public emergency, NIEHS requests 

that the collection of information be 

approved within 14 days of the 

publication of the Federal Register 

notice. This will allow sufficient time 

for public comment. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 10 days of the date of 

this publication. 

Dated: November 18, 2010. 

W. Christopher Long, 

NIEHS, Acting Associate Director for 

Management, National Institutes of Health. 

[FR Doc. 2010–29944 Filed 11–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Advisory Board, December 7, 2010, 9 

a.m. to December 7, 2010, 5:30 p.m., 

National Institutes of Health, Building 

31, 31 Center Drive, Bethesda, MD 

20892 which was published in the 

Federal Register on November 8, 2010, 

75 FR 68611. 

This notice is amending the start and 

end times of the closed session from 

4:30 p.m.–5:30 p.m. to 4:15 p.m. to 5 

p.m. The adjournment time of this 

meeting has also been changed from 

5:30 p.m. to 5 p.m. 

Dated: November 22, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–29950 Filed 11–26–10; 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, Member 

Conflict: BMIT/CMIP/MEDI Imaging 

Applications. 

Date: December 17, 2010. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Telephone Conference Call). 

Contact Person: Dharam S. Dhindsa, DVM, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5110, 

MSC 7854, Bethesda, MD 20892. (301) 435– 

1174. dhindsad@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Topics in 

Microbiology. 

Date: December 28–29, 2010. 

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: Fouad A. El-Zaatari, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3206, 

MSC 7808, Bethesda, MD 20814–9692. (301) 

435–1149. elzaataf@csr.nih.gov. 

Name of Committee: Risk, Prevention and 

Health Behavior Integrated Review Group, 

Psychosocial Risk and Disease Prevention 

Study Section. 

Date: January 27–28, 2011. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Serrano Hotel, 405 Taylor Street, 

San Francisco, CA 94102. 

Contact Person:Stacey FitzSimmons, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

MSC 7808, Bethesda, MD 20892. 301–451– 

9956. fitzsimmonss@csr.nih.gov. 

Name of Committee: Oncology 2— 

Translational Clinical Integrated Review 

Group, Developmental Therapeutics Study 

Section. 

Date: January 27–28, 2011. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Alexandria Old Town, 1767 

King Street, Alexandria, VA 22314. 

Contact Person: Sharon K. Gubanich, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

MSC 7804, Bethesda, MD 20892. (301) 408– 

9512. gubanics@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group, Acute Neural Injury and Epilepsy 

Study Section. 

Date: January 27–28, 2011. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Fairmont San Francisco, 950 Mason 

Street, San Francisco, CA 94108. 

Contact Person: Seetha Bhagavan, PhD, 

Scientific Review Officer, Center for 

mstockstill on DSKH9S0YB1PROD with NOTICES