Proposed Collection; Comment Request; the Atherosclerosis Risk in Communities Study (ARIC), 62544-62545 [2010-25641]

Download as PDF 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 Estimated number of respondents Respondent type 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. Estimated number of hours per respondent type Frequency of response Estimated total annual burden hours requested 500 500 1,213 1,350 .25 .08 .33 .25 .5 .5 .5 .5 62.5 20 200 169 Total ........................................................................................................ srobinson on DSKHWCL6B1PROD with NOTICES Users survey .................................................................................................. Nonusers survey ............................................................................................ Trainees/scholars survey ............................................................................... Mentors survey .............................................................................................. ........................ ........................ ........................ 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 VerDate Mar<15>2010 17:43 Oct 08, 2010 Jkt 223001 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) 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 SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\12OCN1.SGM 12OCN1 62545 Federal Register / Vol. 75, No. 196 / Tuesday, October 12, 2010 / Notices 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 Estimated number of respondents Type of respondents Estimated number of responses per respondent Average burden hours per response Participants ......................................................................................................... Physician (or coroner) (for CHD) ....................................................................... Physician (for heart failure) ................................................................................ Participants’ next of kin ...................................................................................... 10,933 420 920 400 3 1 1 1 0.6165 0.1667 0.0833 0.1667 Totals .......................................................................................................... 12,673 ........................ ........................ Estimated total annual burden hours requested 20220.6. 70. 76.6. 66.7. 20433.9 or 20434. Note: Reported and calculated numbers differ slightly due to rounding. srobinson on DSKHWCL6B1PROD with NOTICES 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 VerDate Mar<15>2010 17:43 Oct 08, 2010 Jkt 223001 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. 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: https:// 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 SUMMARY: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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). E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 75, Number 196 (Tuesday, October 12, 2010)]
[Notices]
[Pages 62544-62545]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25641]

-----------------------------------------------------------------------

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 bi-annually 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

[[Page 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
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average Estimated total annual
Type of respondents number of responses per burden hours burden hours requested
respondents respondent per response
----------------------------------------------------------------------------------------------------------------
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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.