62544 Federal Register / Vol. 75, No. 196 / Tuesday, October 12, 2010 / Notices 

Translational Science Awards (CTSA) 

Initiative. Type of Information 

Collection Request: New. Need and Use 

of Information Collection: The CTSA 

Initiative is directed at transforming the 

way biomedical research is conducted 

nationwide by reducing the time it takes 

for basic science or laboratory 

discoveries to become treatments for 

patients, and for those treatments in 

turn to be incorporated and 

disseminated throughout community 

practice. The primary purpose of this 

data collection is to provide information 

about the process and early outcomes 

associated with 46 awardees 

participating in the first four cohorts of 

CTSA awards, in order to fulfill the 

congressional expectations for external 

program evaluation. NIH will use the 

results to understand the extent to 

which the CTSA Initiative is bringing 

about transformational changes in 

clinical and translational science among 

academic medical centers and their 

research partners, increasing the 

efficiency of the research process, and 

enhancing the capacity of the field to 

conduct clinical and translational 

research. All information collected will 

be used to provide analytical and policy 

support to NCRR, assisting NIH in 

making decisions about current CTSA 

programming, future funding, and other 

initiatives to improve clinical and 

translational science. It may also 

provide information for NIH’s 

Government Performance and Results 

Act (GPRA) report. Frequency of 

Response: Biennial. Affected Public: 

Individuals. Type of Respondents: 

Scientific researchers. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

3,563; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours Per Response: 0.13; Estimated 

Total Annual Burden Hours Requested: 

451.5. The annualized cost to 

respondents is estimated at $14,056. 

There are no capital or start-up costs, 

and no maintenance or service cost 

components to report. 

Respondent type 

Estimated 

number of 

respondents 

Estimated 

number of 

hours per 

respondent 

type 

Frequency of 

response 

Estimated total 

annual burden 

hours 

requested 

Users survey .................................................................................................. 500 .25 .5 62 .5 

Nonusers survey ............................................................................................ 500 .08 .5 20 

Trainees/scholars survey ............................................................................... 1,213 .33 .5 200 

Mentors survey .............................................................................................. 1,350 .25 .5 169 

Total ........................................................................................................ ........................ ........................ ........................ 451 .5 

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 Patricia Newman, 

Program Analyst, Office of Science 

Policy, National Center for Research 

Resources, 6701 Democracy Boulevard, 

MSC 4874, Bethesda, Maryland 20892– 

4874, or e-mail your request, including 

your address to pnewman@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: October 4, 2010. 

Patricia Newman, 

Program Analyst, Office of Science Policy, 

NCRR, National Institutes of Health. 

[FR Doc. 2010–25589 Filed 10–8–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; the Atherosclerosis Risk in 

Communities Study (ARIC) 

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 be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: The 

Atherosclerosis Risk in Communities 

Study (ARIC). Type of Information 

Collection Request: Revision of a 

currently approved collection (OMB 

NO. 0925–0281). Need and Use of 

Information Collection: ARIC will 

conduct a clinical examination of the 

cohort over a 24-month period (May 

2011 to April 2013). In addition, this 

project involves biennual follow-up by 

telephone of participants in the ARIC 

study, review of their medical records, 

and interviews with doctors and family 

to identify disease occurrence. 

Interviewers will contact doctors and 

hospitals to ascertain participants’ 

cardiovascular events. Information 

gathered will be used to further describe 

the risk factors, occurrence rates, and 

consequences of cardiovascular disease 

in middle aged and older men and 

women. Frequency of Response: The 

participants will be contacted biannually for follow-up. A subset of the 

cohort may choose to volunteer for the 

clinical examination; these individually 

will be contacted once in a 3 year 

period. Affected Public: Individuals or 

households; Businesses or other for 

profit; Small businesses or 

organizations. Type of Respondents: 

Individuals or households; doctors and 

staff of hospitals and nursing homes. 

The annual reporting burden is as 

follows: Estimated Number of 

Respondents: 12,673; Estimated Number 

of Responses per Respondent: 2.7; 

Average Burden Hours Per Response: 

0.5916; and Estimated Total Annual 

Burden Hours Requested: 20,434. The 

annualized cost to respondents is 

estimated at $355,882, assuming 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 196 / Tuesday, October 12, 2010 / Notices 62545 

respondents time at the rate of $17.00 

per hour and physician time at the rate 

of $75.00 per hour. There are no Capital 

Costs to report. There are no Operating 

or Maintenance Costs to report. 

TABLE A.12.1 ESTIMATES OF HOUR BURDEN

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

requested 

Participants ......................................................................................................... 10,933 3 0.6165 20220.6. 

Physician (or coroner) (for CHD) ....................................................................... 420 1 0.1667 70. 

Physician (for heart failure) ................................................................................ 920 1 0.0833 76.6.

Participants’ next of kin ...................................................................................... 400 1 0.1667 66.7. 

Totals .......................................................................................................... 12,673 ........................ ........................ 20433.9 or 

20434. 

Note: Reported and calculated numbers differ slightly due to rounding. 

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 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 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

For Further Information: To request 

more information on the proposed 

project or to obtain a copy of the data 

collection plans and instruments, 

contact Dr. Hanyu Ni, Project Officer, 

NIH, NHLBI, 6701 Rockledge Drive, 

MSC 7934, Bethesda, MD 20892–7934, 

or call non-toll-free number (301) 435– 

0448 or E-mail your request, including 

your address to: 

NiHanyu@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. 

Dated: October 6, 2010. 

Suzanne Freeman, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

Michael Lauer, 

Director, DCVS, National Institutes of Health. 

[FR Doc. 2010–25641 Filed 10–8–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–F–0510] 

Ferm Solutions, Inc.; Filing of Food 

Additive Petition (Animal Use); 

Virginiamycin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Ferm Solutions, Inc. has filed a 

petition proposing that the food additive 

regulations be amended to provide for 

the safe use of virginiamycin as an 

antimicrobial processing aid in fuelethanol fermentations with respect to its 

consequent presence in by-product 

distiller grains used as an animal feed 

or feed ingredient. 

DATES: Submit either electronic or 

written comments on the petitioner’s 

environmental assessment by November 

12, 2010. 

ADDRESSES: Submit electronic 

comments to: http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Isabel W. Pocurull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6853, email: isabel.pocurull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(section 409(b)(5) (21 U.S.C. 348(b)(5)), 

notice is given that a food additive 

petition (FAP 2264) has been filed by 

Ferm Solutions, Inc., PO Box 203, 

Danville, KY 40422. The petition 

proposes to amend the food additive 

regulations in part 573 Food Additives 

Permitted in Feed and Drinking Water of 

Animals (21 CFR part 573) to provide 

for the safe use of virginiamycin as an 

antimicrobial processing aid in fuelethanol fermentations with respect to its 

consequent presence in by-product 

distiller grains used as an animal feed 

or feed ingredient. 

The potential environmental impact 

of this action is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see DATES and ADDRESSES) for public 

review and comment. 

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. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the agency finds 

that an environmental impact statement 

is not required and this petition results 

in a regulation, the notice of availability 

of the agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 


srobinson on DSKHWCL6B1PROD with NOTICES