Agency Information Collection Activities: Submission for OMB Review; Comment Request, 33311-33312 [E6-8910]

Download as PDF Federal Register / Vol. 71, No. 110 / Thursday, June 8, 2006 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. cprice-sewell on PROD1PC66 with NOTICES ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Minneapolis District, in cooperation with the Association of Clinical Research Professionals (ACRP), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, August 23, 2006, from 8 a.m. to 5 p.m. and Thursday, August 24, 2006, from 8:30 a.m. to 12 noon. Location: The public workshop will be held at The Northland Inn, 7025 Northland Dr., Brooklyn Park, MN 55428, 800–441–6422 or 763–536–8300, FAX: 763–536–8790. Contact: Amy C. Johnson, Public Affairs Specialist, Food and Drug Administration, 212 3rd Ave. South Minneapolis, MN 55401, 612–758–7131, FAX: 612–334–4134, e-mail: amy.johnson@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $220 (ACRP Minnesota chapter member), $280 (nonmember), or $220 (Government employee). Make registration fee payable to ACRP, and mail to the attention of Paul Below, 441 Timberland Dr., Burnsville, MN 55337. To register via the Internet please go to https://mnacrp.org/ or contact the ACRP webmaster at webmaster@mnacrp.org. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact Paul Below for ACRP at 441 Timberland Dr., Burnsville, MN 55337, 952–882– VerDate Aug<31>2005 15:37 Jun 07, 2006 Jkt 208001 4083, FAX: 952–223–1665, e-mail: webmaster@mnacrp.org. Attendees are responsible for their own accommodations. To make reservations at the Northland Inn at a rate of $119.00 plus tax, please contact the Northland Inn (see Location). The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Amy Johnson (see Contact) at least 7 days in advance of the workshop. SUPPLEMENTARY INFORMATION: The workshop on FDA clinical trials statutory and regulatory requirements helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health by educating researchers on proper conduct of clinical trials. Topics for discussion at the workshop include the following: 1. Medical device and drug aspects of clinical research requirements, 2. Pre-investigational device and preinvestigational drug meetings with FDA, 3. Investigator initiated research, 4. Electronic documentation and data capture, 5. Ethical issues in subject enrollment, 6. Informed consent requirements, 7. Adverse event reporting, 8. FDA regulation of institutional review boards, 9. How FDA conducts bioresearch inspections, 10. FDA Enforcement actions associated with clinical research, and 11. How FDA promotes confidence in clinical research. FDA has made education of the research community a high priority to ensure the quality of clinical data and protect research subjects. The workshop will also help to implement the objectives of section 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA Plan for Statutory Compliance, which includes working more closely with stakeholders and ensuring access to needed scientific and technical expertise. The workshop also furthers the goals of the Small Business Regulatory Enforcement Fairness Act (Public Law 104–121) by providing outreach activities by Government agencies directed to small businesses. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 33311 Dated: May 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–8896 Filed 6–7–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Project: 2007 National Survey on Drug Use and Health—(OMB No. 0930– 0110)—Revision The National Survey on Drug Use and Health (NSDUH), formerly the National Household Survey on Drug Abuse (NHSDA) is a survey of the civilian, non-institutionalized population of the United States 12 years old and older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, ONDCP, Federal Government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources. With the exception of the addition of several follow-up questions on methamphetamine use, no changes to the questionnaire are proposed for the 2007 NSDUH. The proposed additional questions (age at first use and frequency of use in the past 12 months) will be asked of respondents who denied use of methamphetamine in the ‘‘core’’ NSDUH because they didn’t think of it as a prescription drug, but in a later series of questions admit to use (Respondents who report use of methamphetamine in the ‘‘core’’ already receive questions on age at first use and frequency of use). The additional burden associated with the new questions will be negligible because only a small subset of the sample will receive them. As with all NSDUH/NHSDA surveys conducted since 1999, the sample size of the survey for 2007 will be sufficient to permit prevalence estimates for each E:\FR\FM\08JNN1.SGM 08JNN1 33312 Federal Register / Vol. 71, No. 110 / Thursday, June 8, 2006 / Notices of the fifty states and the District of Columbia. The total annual burden estimate is shown below: Number of respondents Activity Average burden hours per respondent Number of responses per respondent Total burden hours Household Screening .................................................................................... Interview ......................................................................................................... Screening Verification .................................................................................... Interview Verification ...................................................................................... 182,250 67,500 5,494 10,125 1 1 1 1 .083 1.0 .067 .067 15,127 67,500 368 678 Total ........................................................................................................ 182,250 ........................ ........................ 83,673 Written comments and recommendations concerning the proposed information collection should be sent by July 10, 2006 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB’s receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202–395–6974. Dated: May 26, 2006. Anna Marsh, Director, Office of Program Services. [FR Doc. E6–8910 Filed 6–7–06; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND SECURITY [USCG–2004–19621] RIN 1625–AA89 Dry Cargo Residue Discharges in the Great Lakes Coast Guard, DHS. Notice of public meeting; request for comments. AGENCY: cprice-sewell on PROD1PC66 with NOTICES ACTION: SUMMARY: The Coast Guard announces a public scoping meeting in support of the National Environmental Policy Act (NEPA) analysis for this rulemaking, which concerns the regulation of dry cargo residues or sweepings in the Great Lakes. We also announce the availability of a sampling plan proposal that the Coast Guard may implement, in part or in whole, as part of this NEPA analysis, and we request public comments on that proposal. DATES: The public scoping meeting will be held on July 6, 2006, from 1 p.m. to 5 p.m. Comments and related material must reach the Docket Management Facility on or before July 31, 2006. ADDRESSES: The public scoping meeting will be held at the Anthony J. Celebreeze Federal Building, 31st floor VerDate Aug<31>2005 15:37 Jun 07, 2006 Jkt 208001 auditorium, 1240 E 9th Street, Cleveland, OH 44199, telephone (216) 902–6020; photo identification required for entrance. In addition to submitting written statements or making verbal comments at the public scoping meeting, you may submit comments identified by Coast Guard docket number USCG–2004– 19621 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods: (1) Web Site: https://dms.dot.gov. (2) Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590–0001. (3) Fax: 202–493–2251. (4) Delivery: Room PL–401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202–366– 9329. For further information about this rulemaking, contact Lieutenant Commander Mary Sohlberg, U.S. Coast Guard, Environmental Standards Division, telephone: 202–372–1429, email: msohlberg@comdt.uscg.mil. Information about the public scoping meeting will be available at https:// www.uscg.mil/hq/g-m/mso/dry cargo.htm. If you need special arrangements to attend the public scoping meeting, contact LTJG Regan Blomshield, U.S. Coast Guard District Nine, telephone: 216–902–6050, e-mail: rblomshield@d9.uscg.mil. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–493–0402. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Public Scoping Meeting The public scoping meeting will be held in a handicapped accessible facility. Please note that you will be PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 required to provide photo identification to enter the facility. If you need special arrangements, please use the contact information in FOR FURTHER INFORMATION CONTACT. The meeting will start with an overview presentation, followed by a formal public comment period. Following the formal public comment period, we will hold an informal open house. At the open house, Coast Guard personnel will be available to provide more information about the NEPA and rulemaking processes, dry cargo residue discharges, and the Coast Guard’s proposed regulatory action, which we described in an earlier notice (71 FR 12210, March 9, 2006). A court reporter will be present during both the formal public comment period and the informal open house, to record verbal comments from the public. The public will also be able to submit written comments at any time during the meeting. Verbal comments to the court reporter will be transcribed, and the transcription will be placed in the public docket along with any written statements that may be submitted during the meeting. These comments and statements will be addressed by the Coast Guard as part of the Environmental Impact Statement. Request for Comments We published a notice on March 9, 2006 (71 FR 12210), requesting public comments on any significant environmental issues related to the Coast Guard’s proposed regulatory action. The public comment period for that notice remains open until July 31, 2006. In addition, we request public comments on, or information relevant to, the proposed sampling plan discussed below. All comments received will be posted, without change, to https://dms.dot.gov and will include any personal information you have provided. We have an agreement with the Department of Transportation (DOT) to use the Docket Management Facility. Please see DOT’s ‘‘Privacy Act’’ paragraph below. E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 71, Number 110 (Thursday, June 8, 2006)]
[Notices]
[Pages 33311-33312]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8910]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under OMB review, in compliance with the Paperwork 
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these 
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.

Project: 2007 National Survey on Drug Use and Health--(OMB No. 0930-
0110)--Revision

    The National Survey on Drug Use and Health (NSDUH), formerly the 
National Household Survey on Drug Abuse (NHSDA) is a survey of the 
civilian, non-institutionalized population of the United States 12 
years old and older. The data are used to determine the prevalence of 
use of tobacco products, alcohol, illicit substances, and illicit use 
of prescription drugs. The results are used by SAMHSA, ONDCP, Federal 
Government agencies, and other organizations and researchers to 
establish policy, direct program activities, and better allocate 
resources.
    With the exception of the addition of several follow-up questions 
on methamphetamine use, no changes to the questionnaire are proposed 
for the 2007 NSDUH. The proposed additional questions (age at first use 
and frequency of use in the past 12 months) will be asked of 
respondents who denied use of methamphetamine in the ``core'' NSDUH 
because they didn't think of it as a prescription drug, but in a later 
series of questions admit to use (Respondents who report use of 
methamphetamine in the ``core'' already receive questions on age at 
first use and frequency of use). The additional burden associated with 
the new questions will be negligible because only a small subset of the 
sample will receive them.
    As with all NSDUH/NHSDA surveys conducted since 1999, the sample 
size of the survey for 2007 will be sufficient to permit prevalence 
estimates for each

[[Page 33312]]

of the fifty states and the District of Columbia. The total annual 
burden estimate is shown below:

----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average
                    Activity                         Number of     responses per   burden hours    Total burden
                                                    respondents     respondent    per respondent       hours
----------------------------------------------------------------------------------------------------------------
Household Screening.............................         182,250               1            .083      15,127
Interview.......................................          67,500               1             1.0      67,500
Screening Verification..........................           5,494               1            .067         368
Interview Verification..........................          10,125               1            .067         678
                                                 ---------------------------------------------------------------
    Total.......................................         182,250  ..............  ..............      83,673
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by July 10, 2006 to: SAMHSA Desk 
Officer, Human Resources and Housing Branch, Office of Management and 
Budget, New Executive Office Building, Room 10235, Washington, DC 
20503; due to potential delays in OMB's receipt and processing of mail 
sent through the U.S. Postal Service, respondents are encouraged to 
submit comments by fax to: 202-395-6974.

    Dated: May 26, 2006.
Anna Marsh,
Director, Office of Program Services.
 [FR Doc. E6-8910 Filed 6-7-06; 8:45 am]
BILLING CODE 4162-20-P
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