22578 Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Notices 

A. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. Arthur L. Loomis, II, Patricia A. 

Loomis, Genevieve E. Loomis, and Julia 

P. Loomis, all of Niskayuna, New York; 

Florence Porter Loomis, Frederick S. 

Loomis, Anne M. Loomis, and J. Porter 

Loomis, all of Pratt, Kansas; Howard K. 

Loomis, Jr., Karen P. Loomis, Katherine 

P. Loomis, Margaret P. Loomis, and 

Victoria K. Loomis, all of Los Gatos; 

California, as individuals and/or 

trustees of the 2011 Arthur L. Loomis, II 

Gift Trust, the Julia P. Loomis Revocable 

Trust, the Arthur L. Loomis, II Revocable 

Trust, the Genevieve E. Loomis 

Revocable Trust, all of Niskayuna, New 

York; the Howard K. Loomis Revocable 

Trust, the 2010 Howard K. Loomis 

Irrevocable Family Trust, the Porter 

Legacy Trust, Florence Porter Loomis 

Trust, the 2010 Florence Porter Loomis 

Irrevocable Family Trust, the 2011 

Frederick S. Loomis Gift Trust, the 2011 

J. Porter Loomis Gift Trust, all of Pratt, 

Kansas; the 2011 Howard K. Loomis Jr. 

Gift Trust, The Loomis 1993 Revocable 

Trust, both of Los Gatos, California; and 

Flopper, L.P., How-Kan, L.P., and 

Driftwood, LLC, all of Pratt, Kansas; and 

all as members of the Loomis Family 

Group, to retain control of Krey Co. Ltd., 

and thereby indirectly retain control of 

The Peoples Bank, both in Pratt, Kansas. 

Comments on this application must 

be received by April 20, 2012. 

Board of Governors of the Federal Reserve 

System, April 11, 2012. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2012–9033 Filed 4–13–12; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Information 

Program on Clinical Trials: Maintaining 

a Registry and Results Databank 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Library of Medicine (NLM), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on February 9, 2012 (Vol. 77, 

No. 27, p. 6808) and allowed 60-days for 

public comment. A single public 

comment was received. The purpose of 

this notice is to allow an additional 30 

days for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection: Title: 

Information Program on Clinical Trials: 

Maintaining a Registry and Results 

Databank; Type of Information 

Collection Request: Revision of 

currently approved collection [OMB No. 

0925–0586, expiration date 04/30/2012], 

Form Number: NA; Need and Use of 

Information Collection: The National 

Institutes of Health operates 

ClinicalTrials.gov, which was 

established as a clinical trial registry 

under section 113 of the Food and Drug 

Administration Modernization Act of 

1997 (Pub. L. 105–115) and was 

expanded to include a results data bank 

by Title VIII of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA). ClinicalTrials.gov 

collects registration and results 

information for clinical trials and other 

types of clinical studies (e.g., 

observational studies and patient 

registries) with the objectives of 

enhancing patient enrollment and 

providing a mechanism for tracking 

subsequent progress of clinical studies, 

to the benefit of public health. It is 

widely used by patients, physicians, 

and medical researchers; in particular 

those involved in clinical research. 

While many clinical studies are 

registered voluntarily, FDAAA requires 

the registration of certain applicable 

clinical trials of drugs and devices and 

the submission of results information 

for completed applicable clinical trials 

of drugs and devices that are approved, 

licensed, or cleared by the Food and 

Drug Administration. Beginning in 

2009, results information was required 

to include information about serious 

and frequent adverse events. As the 

existing PRA clearance for this 

information collection nears expiration, 

we are making a limited number of 

revisions to include additional data 

elements that may be voluntarily 

submitted to describe and aid in the 

interpretation of any submitted adverse 

event information, to facilitate the 

registration of patient registries, and to 

account for the burden of establishing 

an account with the ClinicalTrials.gov 

Protocol Registration System (PRS). 

Frequency of Response: For clinical 

trials that are subject to FDAAA, 

responsible parties must register once, 

not later than 21 days after enrolling the 

first subject. Updates to submitted 

information are required at least once a 

year, if there are changes to report, 

although changes in recruitment status 

and completion of a trial must be 

reported not later than 30 days after 

such events. Results information is to be 

submitted not later than 12 months after 

the completion date (as defined in the 

law), but can be delayed under certain 

circumstances. Other clinical studies 

also register once, at their inception, 

and are requested to update information 

annually, as necessary. An organization 

must establish a PRS account one time 

in order to register studies (and submit 

results) with ClinicalTrials.gov. 

Description of Respondents: 

Respondents include sponsors or 

principal investigators of clinical 

studies. Those subject to FDAAA are 

referred to as ‘‘responsible parties,’’ 

which are defined as sponsors of the 

clinical trial (as defined in 21 CFR 50.3) 

or designated principal investigators 

who meet requirements specified in the 

law. Estimate of Burden: The burden 

associated with this information 

collection is calculated in three parts: 

the burden associated with the one-time 

process of applying for a PRS account at 

ClinicalTrials.gov; the burden 

associated with registration; and the 

burden associated with the submission 

of results information, including 

adverse events. These information 

collections will occur at different times, 

but the registration and results 

information will be integrated into a 

single record for each clinical trial, 

which is entered through the PRS 

account. Based on data from 2011, we 

estimate that 5,500 new PRS account 

applications will be submitted annually. 

The time necessary to collect the 

required information and enter it into a 

new application form is estimated at 15 

minutes. Using these figures, we 

estimate the total annual burden of 

submitting an application for a new PRS 

account to be 1,375 hours (5,500 

applications per year times 0.25 hours 

per application). To estimate the annual 

reporting burden for registration, we 

examined the number of clinical studies 

registered annually with 

ClinicalTrials.gov and found an average 

of 17,000 registrations per year since the 

enactment of FDAAA. From this total, 

we estimate that approximately 5,000 

studies would be applicable clinical 

trials of drugs (including biological 

products) and 500 would be applicable 

trials of devices subject to FDAAA. The 

remaining 11,500 studies would be 

registered voluntarily. We estimate the 

time to complete an initial registration 


emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Notices 22579 

to be 7 hours (including time to extract, 

reformat and submit information which 

has already been produced for other 

purposes). This estimate is consistent 

with that used on the previous PRA 

clearance and incorporates 4 hours for 

data extraction and 3 hours for 

reformatting. Based on previous 

experience, we estimate that each 

registration record will be updated an 

average of eight times and that each 

update takes approximately 2 hours. 

Applying these figures to the estimated 

number of trials to be registered per year 

produces an annual burden estimate of 

391,000 hours. Of this total, 126,500 

hours are associated with the mandatory 

registration of trials subject to FDAAA, 

and 264,500 hours are associated with 

voluntary registrations. The burden of 

results submission consists of the time 

and effort needed to summarize 

information from a clinical trial, format 

it, and enter it into the databank. We 

estimate that of the 5,500 applicable 

clinical trials that are registered each 

year, approximately 1,845 will be 

required to submit results each year 

(1,500 trials of drugs and biological 

products, and 345 trials of devices). We 

estimate that each results record will 

submitted once and updated twice to 

reflect changes in the data analysis, 

additional results of subsequent prespecified outcome measures, or 

additional adverse event information. 

Based on information available from 

various organizations about results 

submission times, comments made at a 

public meeting held in April 2009, 

responses to estimates in previous OMB 

clearance documents (73 FR 58972, Oct. 

8, 2008), and feedback from respondents 

who have submitted results to 

ClinicalTrials.gov, we have increased 

our estimate of the average response 

time to 25 hours from the 10 hour 

estimate included in the previous OMB 

clearance request. We estimate that 

updates take 8 hours, an increase over 

the 5 hour estimate included in the 

previous OMB clearance request for 

adverse event information. In addition, 

we estimate that 3,655 trials per year 

will submit certifications to 

ClinicalTrials.gov indicating that they 

qualify for delayed results submission, 

and another 200 trials will request 

extensions to the submission deadline 

for good cause, as permitted by FDAAA. 

We expect that it would take no more 

than 30 minutes for a responsible party 

to determine that a certification is 

required and to submit the necessary 

information through ClinicalTrials.gov. 

For extension requests, we estimate that 

the time to prepare a request and submit 

it to ClinicalTrials.gov would be no 

more than 2 hours. Using these figures, 

we estimate the annualized hourly 

burden for submitting results 

information, certifications, and 

extension requests to be 77,872.5 hours. 

There are no capital 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, 

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: David 

Sharlip, National Library of Medicine, 

Building 38A, Room B2N12, 8600 

Rockville Pike, Bethesda, MD 20894, or 

call non-toll free number 301–402–9680 

or email your request to 

sharlipd@mail.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: April 10, 2012. 

David H. Sharlip, 

NLM Project Clearance Liaison, National 

Library of Medicine, National Institutes of 

Health. 

[FR Doc. 2012–9083 Filed 4–13–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 USC, 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel ETechnology Tools for Extending the Reach of 

Prevention Interventions in Rural and 

Remote Locations (5567) 

Date: April 30, 2012. 

Time: 1:30 p.m. to 5 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Nadine Rogers, Ph.D., 

Scientific Review Officer, 

Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, 6001 Executive Blvd., Room 4229, 

MSC 9550, Bethesda, MD 20892–9550, 301– 

402–2105, rogersn2@nida.nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel Rapid 

Portable Devices to Measure Drug Use (1206). 

Date: May 1, 2012. 

Time: 1:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Lyle Furr, Contract Review 

Specialist, Office of Extramural Affairs, 

National Institute on Drug Abuse, NIH, 

DHHS, Room 4227, MSC 9550, 6001 

Executive Boulevard, Bethesda, MD 20892– 

9550, (301) 435–1439, lf33c.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos.: 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: April 10, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–9055 Filed 4–13–12; 8:45 am] 

BILLING CODE 4140–01–P 


emcdonald on DSK29S0YB1PROD with NOTICES