Submission for OMB Review; Comment Request; The NIH-American Association for Retired Persons (AARP) interactive Comprehensive Lifestyle Interview by Computer Study (iCLIC) (NCI), 80828-80829 [2010-32333]

Download as PDF 80828 Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0575] Draft Compliance Policy Guide Sec. 510.800 Beverages—Serving Size Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of draft ‘‘Compliance Policy Guide Sec. 510.800 Beverages—Serving Size Labeling’’ (the draft CPG). The draft CPG, when finalized, will provide guidance for FDA staff on FDA’s exercise of enforcement discretion related to serving size labeling for certain beverages that are packaged in containers larger than 20 fluid ounces and that display calories per 12 fluid ounce serving on the front of the container. SUMMARY: Although you can comment on any CPG at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft CPG before it begins work on the final version of the CPG, submit either electronic or written comments on the draft CPG by February 22, 2011. ADDRESSES: Submit electronic comments on the draft CPG to https:// www.regulations.gov. Submit written comments on the draft CPG to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft CPG to the Division of Compliance Policy (HFC– 230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your request or fax your request to 240–632–6861. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft CPG. FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1450. SUPPLEMENTARY INFORMATION: mstockstill on DSKH9S0YB1PROD with NOTICES DATES: I. Background The draft CPG is intended to provide guidance for FDA staff on the labeling of certain beverages. In particular, the draft CPG sets forth a policy to typically consider not taking an enforcement VerDate Mar<15>2010 18:06 Dec 22, 2010 Jkt 223001 action when a beverage container larger than 20 fluid ounces states the calories per 12 fluid ounces on the Principal Display Panel (PDP) and correspondingly provides the number of 12 fluid ounce servings in the container and the nutrition information is based on a 12 fluid ounce serving in the Nutrition Facts panel. FDA’s labeling regulations require that the labeled serving size be based on Reference Amounts Customarily Consumed (RACC) (21 CFR 101.9(b) and § 101.12(b) (21 CFR 101.12(b))). The RACC for beverages is 240 milliliters (8 fluid ounces) (§ 101.12(b)). FDA’s exercise of enforcement discretion is limited to the following beverages in containers that are larger than 20 fluid ounces and that display calories on the PDP of the label per 12 ounces: (1) Sports drinks (this term is used by industry and has not been defined by the Agency), (2) bottled water and water beverages, (3) soft drinks and diet soft drinks, (4) energy drinks (this term is used by industry and has not been defined by the Agency), and (5) ready-to-drink teas. The CPG reflects the Agency’s recent response to the American Beverage Association’s request that FDA exercise enforcement discretion for industry to label certain beverages based on a 12 fluid ounce serving size (Refs. 1, 2, and 3). The draft CPG also contains information that may be useful to the regulated industry and to the public. FDA is issuing the draft CPG as level 1 draft guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft CPG, when finalized, will represent FDA’s current thinking on the exercise of enforcement discretion for serving size labeling for the applicable beverages. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments 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. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the Internet may obtain the draft CPG from FDA’s Office of Regulatory Affairs history page at https://www.fda.gov/ora/ compliance_ref/cpg/default.htm. IV. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. Letter from Stuart M. Pape, Counsel to the American Beverage Association, May 27, 2010. 2. Letter from Stuart M. Pape, Counsel to the American Beverage Association, June 24, 2010. 3. Letter from Michael R. Taylor, Deputy Commissioner for Foods, FDA, July 12, 2010. Dated: December 13, 2010. Dara Corrigan, Associate Commissioner for Regulatory Affairs. [FR Doc. 2010–32249 Filed 12–22–10; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; The NIH–American Association for Retired Persons (AARP) interactive Comprehensive Lifestyle Interview by Computer Study (iCLIC) (NCI) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 October 18, 2010 (75 FR 63833) and allowed 60-days for public comment. There was one public comment received on October 18, 2010 which questioned the use of ‘‘spending American tax dollars on this study.’’ A response was sent on December 14, 2010. 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, SUMMARY: E:\FR\FM\23DEN1.SGM 23DEN1 Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NIH– American Association for Retired Persons (AARP) Comprehensive Lifestyle Interview by Computer (CLIC) Study. Type of Information Collection Request: Extension. Need and Use of Information Collection: The Nutritional Epidemiology Branch of the Division of Cancer Epidemiology and Genetics of the National Cancer Institute has planned this study to evaluate the feasibility of using these three new computerized questionnaires as well as the Diet and Health Questionnaire (DHQ), a well-established food frequency questionnaire in a population of early-to-late-middle-aged men and women. Participants will be asked to complete computerized questionnaires over a 90 day period, with some questionnaires in a series being completed twice. This evaluation study comprises the necessary performance and feasibility tests for the new computerized questionnaires, which will provide an opportunity to assess the possibility of administering computerized questionnaires in future large prospective cohort studies. The computerized questionnaires will support the ongoing examination between cancer and other health outcomes with nutritional, physical activity, and lifestyle exposures. The computerized questionnaires adhere to The Public Health Service Act, Section 412 (42 U.S.C. 285a–1) and Section 413 (42 U.S.C. 285a–2), which authorizes 80829 the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Either 1 or 2 times. Affected Public: Individuals. Type of Respondents: U.S. adults (aged 50 and over). The annual reporting burden is displayed in the table below. The estimated total annual burden hours being requested is 6886. The annualized cost to respondents is estimated at: $121,743. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS Frequency of response Instrument(s) tested 1.00 Pre-Enrollment (Attachment 6) ........................................................................ 1.00 Enrollment Process (Attachment 7) ................................................................. 1.00 ASA24 (Attachments 4–1) ............................................................................... 2.00 ACT–24 (Attachments 4–2) ............................................................................. 2.00 LHQ (Attachments 4–3) ................................................................................... 1.00 DHQ (Attachments 4–4) .................................................................................. 1.00 Web Re-entry (Attachment 8) .......................................................................... 6.00 Evaluation Survey (Attachment 9) ................................................................... 1.00 Totals ........................................................................................................ mstockstill on DSKH9S0YB1PROD with NOTICES Read Invitation (Attachments 3) ...................................................................... ........................ 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 VerDate Mar<15>2010 18:06 Dec 22, 2010 Jkt 223001 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 Attention: NIH Desk Officer, Office of Management and Budget, at OIRA_submission@omb.eop.gov or by fax to 202–395–6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Arthur Schatzkin, M.D., Dr.P.H, Chief, Nutritional Epidemiology Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute, NIH, DHHS, Executive Plaza South, Room 3040, 6120 Executive Blvd., EPS– MSC 7242, Bethesda, MD 20892–7335 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 Average time per response (minutes/hour) No. of respondents Annual hour burden 1/60 (0.017) 10/60 (0.167) 5/60 (0.083) 30/60 (0.500) 15/60 (0.250) 20/60 (0.333) 45/60 (0.750) 5/60 (0.083) 1/60 (0.017) 16,667.00 278 2,312.00 385 2,288.00 191 1,944.00 1,944 1,944.00 972 1,944.00 648 1,944.00 1,458 1,944.00 972 2,288.00 38 ........................ 33,275.00 6,886 or call non-toll-free number 301–594– 2931 or e-mail your request, including your address to: schatzka@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: December 17, 2010. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2010–32333 Filed 12–22–10; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\23DEN1.SGM 23DEN1

Agencies

[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80828-80829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32333]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; The NIH-American 
Association for Retired Persons (AARP) interactive Comprehensive 
Lifestyle Interview by Computer Study (iCLIC) (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute (NCI), 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 October 
18, 2010 (75 FR 63833) and allowed 60-days for public comment. There 
was one public comment received on October 18, 2010 which questioned 
the use of ``spending American tax dollars on this study.'' A response 
was sent on December 14, 2010. 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,

[[Page 80829]]

1995, unless it displays a currently valid OMB control number.
    Proposed Collection: Title: NIH-American Association for Retired 
Persons (AARP) Comprehensive Lifestyle Interview by Computer (CLIC) 
Study. Type of Information Collection Request: Extension. Need and Use 
of Information Collection: The Nutritional Epidemiology Branch of the 
Division of Cancer Epidemiology and Genetics of the National Cancer 
Institute has planned this study to evaluate the feasibility of using 
these three new computerized questionnaires as well as the Diet and 
Health Questionnaire (DHQ), a well-established food frequency 
questionnaire in a population of early-to-late-middle-aged men and 
women. Participants will be asked to complete computerized 
questionnaires over a 90 day period, with some questionnaires in a 
series being completed twice. This evaluation study comprises the 
necessary performance and feasibility tests for the new computerized 
questionnaires, which will provide an opportunity to assess the 
possibility of administering computerized questionnaires in future 
large prospective cohort studies. The computerized questionnaires will 
support the ongoing examination between cancer and other health 
outcomes with nutritional, physical activity, and lifestyle exposures. 
The computerized questionnaires adhere to The Public Health Service 
Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), 
which authorizes the Division of Cancer Epidemiology and Genetics of 
the National Cancer Institute (NCI) to establish and support programs 
for the detection, diagnosis, prevention and treatment of cancer; and 
to collect, identify, analyze and disseminate information on cancer 
research, diagnosis, prevention and treatment. Frequency of Response: 
Either 1 or 2 times. Affected Public: Individuals. Type of Respondents: 
U.S. adults (aged 50 and over). The annual reporting burden is 
displayed in the table below. The estimated total annual burden hours 
being requested is 6886. The annualized cost to respondents is 
estimated at: $121,743. There are no Capital Costs, Operating Costs, 
and/or Maintenance Costs to report.

                                    Table 1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                   Average time
              Instrument(s) tested                 Frequency of    per response       No. of        Annual hour
                                                     response     (minutes/hour)    respondents       burden
----------------------------------------------------------------------------------------------------------------
Read Invitation (Attachments 3).................            1.00            1/60       16,667.00             278
                                                                         (0.017)
Pre-Enrollment (Attachment 6)...................            1.00           10/60        2,312.00             385
                                                                         (0.167)
Enrollment Process (Attachment 7)...............            1.00            5/60        2,288.00             191
                                                                         (0.083)
ASA24 (Attachments 4-1).........................            2.00           30/60        1,944.00           1,944
                                                                         (0.500)
ACT-24 (Attachments 4-2)........................            2.00           15/60        1,944.00             972
                                                                         (0.250)
LHQ (Attachments 4-3)...........................            1.00           20/60        1,944.00             648
                                                                         (0.333)
DHQ (Attachments 4-4)...........................            1.00           45/60        1,944.00           1,458
                                                                         (0.750)
Web Re-entry (Attachment 8).....................            6.00            5/60        1,944.00             972
                                                                         (0.083)
Evaluation Survey (Attachment 9)................            1.00            1/60        2,288.00              38
                                                                         (0.017)
                                                 ---------------------------------------------------------------
    Totals......................................  ..............  ..............       33,275.00           6,886
----------------------------------------------------------------------------------------------------------------

    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.
    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 Attention: NIH Desk Officer, Office of Management and 
Budget, at OIRA_submission@omb.eop.gov or by fax to 202-395-6974. To 
request more information on the proposed project or to obtain a copy of 
the data collection plans and instruments, contact Arthur Schatzkin, 
M.D., Dr.P.H, Chief, Nutritional Epidemiology Branch, Division of 
Cancer Epidemiology and Genetics, National Cancer Institute, NIH, DHHS, 
Executive Plaza South, Room 3040, 6120 Executive Blvd., EPS-MSC 7242, 
Bethesda, MD 20892-7335 or call non-toll-free number 301-594-2931 or e-
mail your request, including your address to: schatzka@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: December 17, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-32333 Filed 12-22-10; 8:45 am]
BILLING CODE 4140-01-P
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