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