The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI); Correction Notice, 20606 [2010-9098]

Download as PDF 20606 Federal Register / Vol. 75, No. 75 / Tuesday, April 20, 2010 / Notices Dated: April 14, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2010–8977 Filed 4–19–10; 8:45 am] The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI); Correction Notice BILLING CODE 4160–01–S The Federal Register notice published on March 3, 2010 (75 FR 9902) announcing the proposed collection and comment request for the project titled, ‘‘The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI)’’ was submitted with errors. The burden table did not take into account the time related to complete the Phase III CATI as well as several telephone calls to schedule appointments and to follow up with instructions regarding the biospecimens collection. The corrected annual reporting burden is as follows: TABLE A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS Estimated annual number of respondents Frequency of response Average time per response minutes/hour Phase III Telephone Interview & Buccal Cell Scripts. Phase III CATI .......................... 150 1 5/60 (0.083) 12.50 150 1 35/60 (0.583) 87.50 Phase III Buccal Cell Reminder, Missing or Damaged Scripts. BEEA CATI Screener ............... BEEA Home Visit CAPI, Blood, & Urine x 1. BEEA Schedule Home Visit Script. BEEA Home Visit CAPI, Blood, & Urine x 3. 150 1 5/60 (0.083) 12.50 960 310 1 1 20/60 (0.33) 20/60 (0.33) 320.00 5.17 10 3 5/60 (0.33) 2.50 10 3 ≤ 20/60 (0.33) 10.00 ................................................... 1740 ............................ ............................ 450.17 Type of respondent Instrument Private Applicators, Spouses, Commercial Applicators. Private Applicators, Spouses, Commercial Applicators. Private Applicators, Spouses, Commercial Applicators. Private Applicators .................... Private Applicators .................... Private Applicators .................... Private Applicators .................... Total ................................... Dated: April 14, 2010. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. [FR Doc. 2010–9098 Filed 4–19–10; 8:45 am] Submit written requests for single copies of the guidance document entitled ‘‘Tobacco Health Document Submission’’ to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850–3229. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft guidance document may be sent. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document. Submit electronic comments to https:// www.regulations.gov. Submit written comments on the guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. ADDRESSES: BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0600] Guidance for Industry on Tobacco Health Document Submission; Availability AGENCY: Food and Drug Administration, HHS. erowe on DSK5CLS3C1PROD with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Tobacco Health Document Submission.’’ The guidance document is intended to assist persons making certain document submissions to FDA under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). VerDate Nov<24>2008 14:55 Apr 19, 2010 Jkt 220001 FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850– PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Annual burden hours 3229, 1–877–287–1373, Beth.Buckler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of December 28, 2009 (74 FR 68629), FDA announced the availability of a draft guidance entitled ‘‘Tobacco Health Document Submission.’’ The agency considered received comments as it finalized this guidance. The guidance document is intended to assist persons making certain document submissions to FDA under the Tobacco Control Act (Public Law 111–31). The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.) by, among other things, adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 904(a)(4) of the act, as amended by the Tobacco Control Act, requires each tobacco product manufacturer or importer, or agent thereof, to submit all documents developed after June 22, 2009 ‘‘that relate to health, toxicological, E:\FR\FM\20APN1.SGM 20APN1

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[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Page 20606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9098]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


The Agricultural Health Study: A Prospective Cohort Study of 
Cancer and Other Disease Among Men and Women in Agriculture (NCI); 
Correction Notice

    The Federal Register notice published on March 3, 2010 (75 FR 9902) 
announcing the proposed collection and comment request for the project 
titled, ``The Agricultural Health Study: A Prospective Cohort Study of 
Cancer and Other Disease Among Men and Women in Agriculture (NCI)'' was 
submitted with errors. The burden table did not take into account the 
time related to complete the Phase III CATI as well as several 
telephone calls to schedule appointments and to follow up with 
instructions regarding the biospecimens collection. The corrected 
annual reporting burden is as follows:

                                                     Table A.12-1--Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Estimated annual                    Average time per
              Type of respondent                            Instrument                number of       Frequency of    response minutes/   Annual burden
                                                                                     respondents        response            hour              hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Private Applicators, Spouses, Commercial        Phase III Telephone Interview &                150                 1      5/60 (0.083)             12.50
 Applicators.                                    Buccal Cell Scripts.
Private Applicators, Spouses, Commercial        Phase III CATI..................               150                 1     35/60 (0.583)             87.50
 Applicators.
Private Applicators, Spouses, Commercial        Phase III Buccal Cell Reminder,                150                 1      5/60 (0.083)             12.50
 Applicators.                                    Missing or Damaged Scripts.
Private Applicators...........................  BEEA CATI Screener..............               960                 1      20/60 (0.33)            320.00
Private Applicators...........................  BEEA Home Visit CAPI, Blood, &                 310                 1      20/60 (0.33)              5.17
                                                 Urine x 1.
Private Applicators...........................  BEEA Schedule Home Visit Script.                10                 3       5/60 (0.33)              2.50
Private Applicators...........................  BEEA Home Visit CAPI, Blood, &                  10                 3   <= 20/60 (0.33)             10.00
                                                 Urine x 3.
                                                                                 -----------------------------------------------------------------------
    Total.....................................  ................................              1740  ................  ................            450.17
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    Dated: April 14, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-9098 Filed 4-19-10; 8:45 am]
BILLING CODE 4140-01-P
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