Agency Information Collection Activities: Submission for OMB Review; Comment Request, 42646-42647 [E6-12028]

Download as PDF 42646 Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices announcing such classification. Because of the timeframes established by section 513(f)(2) of the act, FDA has determined, under § 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to allow for public participation before issuing this guidance as a final guidance document. Thus, FDA is issuing this guidance document as a level 1 guidance document that is immediately in effect. FDA will consider any comments that are received in response to this notice to determine whether to amend the guidance document. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (§ 10.115). The guidance represents the agency’s current thinking on fecal calprotectin immunological test systems. 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 statute and regulations. rwilkins on PROD1PC63 with NOTICES III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive ‘‘Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240– 276–3151 to receive a hard copy. Please use the document number 1599 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers’ addresses), small manufacturer’s assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. VerDate Aug<31>2005 16:46 Jul 26, 2006 Jkt 208001 IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120, the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073, and the collections of information in 21 CFR part 809 have been approved under OMB control number 0910–0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified 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. Dated: July 19, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–11974 Filed 7–26–06; 8:45 am] BILLING CODE 4160–01–S Open: September 18, 2006, 9 a.m. to 3 p.m. Agenda: Psychoactive Drugs and Type 2 Diabetes. Place: National Institutes of Health, 9000 Rockville Pike, Building 45, Conference Rooms E1/E2. Contact Person: Sanford A. Garfield, PhD, Senior Advisor, Biometrics and Behavioral Science, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, PHS, DHHS, 6707 Democracy Blvd, Room 685, Bethesda, MD 20892, 301–594–8803, Garfields@extra.niddk.nih.gov. Information is also available on the Institute’s/Center’s Web site: https:// www.niddk.nih.gov/federal/dmicc.htm, where an agenda and any additional information for the meeting will be posted when available. For logistics and updated information not available on the Web site, contact Maria Smith, The Scientific Consulting Group, Inc., contractor for the DMICC, at msmith@scgcorp.com. Please note: In the interest of security, NIH has instituted stringent procedures for entrance into the building by nongovernment employees. Persons without a government I.D. will need to show a photo I.D. and sign in at the security desk upon entering the building. Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or x-rayed as they enter NIH buildings. For more information about the new security measures at NIH, please visit the Web site at https://www.nih.gov/about/ visitorsecurity.htm. Dated: July 20, 2006. Sanford A. Garfield, Senior Advisor, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. [FR Doc. E6–12046 Filed 7–26–06; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting Pursuant to section 429 [285c–3] of the Public Health Service Act (Pub. L. 95–158), notice is hereby given of a meeting of the statutory Diabetes Mellitus Interagency Coordinating Committee. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Diabetes Mellitus Interagency Coordinating Committee. Date: September 18, 2006. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 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. Proposed Project: Screening, Brief Intervention, Brief Treatment and Referral to Treatment (SBIRT) CrossSite Evaluation—New SAMHSA’s Center for Substance Abuse Treatment is conducting a cross- E:\FR\FM\27JYN1.SGM 27JYN1 42647 Federal Register / Vol. 71, No. 144 / Thursday, July 27, 2006 / Notices site external evaluation of the impact of programs of screening, brief intervention (BI), brief treatment (BT) and referral to treatment on patients presenting at various health care delivery units with a continuum of severity of substance use. CSAT’s SBIRT program is a cooperative agreement grant program designed to help six States and one Tribal Council expand the continuum of care available for substance misuse and use disorders. The program includes screening, Brief Intervention, Brief Treatment and Referrals (BI, BT) for persons at risk for will be administered to practitioners who are delivering SBIRT services using CAPI. The patient survey is composed of questions on substance use behaviors and other outcome measures such as productivity, absenteeism, health status, arrests and accidents. The practitioner survey is designed to evaluate the implementation of proposed SBIRT models by measuring their penetration and practitioners’ willingness to adopt. Furthermore, the survey will document moderating factors related to practitioner and health care delivery unit characteristics. dependence on alcohol or drugs. The primary purpose of the evaluation is to study the extent to which the modified models of SBIRT being implemented by the grantees expand the continuum of care available for treatment of substance use disorders. A survey will be used to collect data from patients at the participating grantee health care delivery units at baseline using a computer-assisted personal interview (CAPI) and at a sixmonth follow-up primarily via computer-assisted telephone interviewing (CATI). A second survey ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Number of respondents Instrument/activity Average burden per response Total burden hours per collection Patient Survey: Baseline Data Collection .......................................................................... 6-Month Follow-up Data ........................................................................... Practitioner Survey ................................................................................... 3,600 2,880 261 1 1 1 .42 .47 .40 ........................ 1,512 1,354 104 Total ................................................................................................... 3,861 ........................ ........................ 2,970 Written comments and recommendations concerning the proposed information collection should be sent by August 28, 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: July 20, 2006. Anna Marsh, Director, Office of Program Services. [FR Doc. E6–12028 Filed 7–26–06; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Request for Comment From the Field on the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Addiction Technology Transfer Center (ATTC) Program Substance Abuse and Mental Health Services Administration, HHS. SUMMARY: This notice is to request comments from interested stakeholders in the substance use disorders treatment field regarding SAMHSA’s ATTC Program. SAMHSA will be issuing a Request for Applications (RFA) for a rwilkins on PROD1PC63 with NOTICES AGENCY: VerDate Aug<31>2005 16:46 Jul 26, 2006 Jkt 208001 new round of competitive cooperative agreement awards under the ATTC program in Federal fiscal year (FFY) 2007. To assist SAMHSA in developing the RFA, SAMHSA is seeking input from stakeholders and interested parties on a number of issues relating to these cooperative agreements. Program Title: Addiction Technology Transfer Centers (ATTC) Program. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 5001(d)(5) of the Public Health Service Act, as amended. FOR FURTHER INFORMATION CONTACT: Catherine D. Nugent, SAMHSA/CSAT/ DSI, 1 Choke Cherry Road, Room 5– 1079, Rockville, MD 20857, phone: 240– 276–1577, e-mail: cathy.nugent@samhsa.hhs.gov. Introduction The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to building resilience and facilitating recovery for people with or at risk for substance use and mental disorders. SAMHSA collaborates with the States, national associations, local community-based and faith-based organizations, and public and private sector providers to implement initiatives in its priority areas, including development of the workforce serving individuals needing treatment and recovery for substance use disorders. The Center for Substance Abuse Treatment (CSAT) supports training and technology transfer PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 activities to promote the adoption of evidence-based practices in substance use disorders treatment and, more broadly, to promote workforce development in the addiction treatment field. CSAT’s Addiction Technology Transfer Centers (ATTCs), funded by CSAT since 1993, are a major component of SAMHSA/CSAT’s workforce development efforts. The ATTC Network is dedicated to identifying and advancing opportunities for improving addiction treatment. The vision of the ATTCs is to unify science, education and services to transform the lives of individuals and families affected by alcohol and other drug addition. Serving the 50 States, the District of Columbia, Puerto Rico, the U.S. Virgin Islands and the Pacific Islands, the ATTC Network operates as 14 individual Regional Centers and a National Office. At the regional level, individual Centers focus primarily on meeting the unique needs in their areas while also supporting national initiatives. The National Office leads the Network in implementing national initiatives and concurrently supports and promotes individual regional efforts. The current ATTC program is funded through cooperative agreements initially awarded in 2001 and 2002. These cooperative agreements will end in FFY 2007. SAMHSA/CSAT will be issuing a new funding announcement to recompete the ATTCs in FY 2007. To assist CSAT in designing the E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 71, Number 144 (Thursday, July 27, 2006)]
[Notices]
[Pages 42646-42647]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12028]


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

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.

Proposed Project: Screening, Brief Intervention, Brief Treatment and 
Referral to Treatment (SBIRT) Cross-Site Evaluation--New

    SAMHSA's Center for Substance Abuse Treatment is conducting a 
cross-

[[Page 42647]]

site external evaluation of the impact of programs of screening, brief 
intervention (BI), brief treatment (BT) and referral to treatment on 
patients presenting at various health care delivery units with a 
continuum of severity of substance use. CSAT's SBIRT program is a 
cooperative agreement grant program designed to help six States and one 
Tribal Council expand the continuum of care available for substance 
misuse and use disorders. The program includes screening, Brief 
Intervention, Brief Treatment and Referrals (BI, BT) for persons at 
risk for dependence on alcohol or drugs. The primary purpose of the 
evaluation is to study the extent to which the modified models of SBIRT 
being implemented by the grantees expand the continuum of care 
available for treatment of substance use disorders.
    A survey will be used to collect data from patients at the 
participating grantee health care delivery units at baseline using a 
computer-assisted personal interview (CAPI) and at a six-month follow-
up primarily via computer-assisted telephone interviewing (CATI). A 
second survey will be administered to practitioners who are delivering 
SBIRT services using CAPI. The patient survey is composed of questions 
on substance use behaviors and other outcome measures such as 
productivity, absenteeism, health status, arrests and accidents. The 
practitioner survey is designed to evaluate the implementation of 
proposed SBIRT models by measuring their penetration and practitioners' 
willingness to adopt. Furthermore, the survey will document moderating 
factors related to practitioner and health care delivery unit 
characteristics.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of        Average      Total burden
               Instrument/activity                   Number of     responses per    burden  per      hours per
                                                    respondents     respondent       response       collection
----------------------------------------------------------------------------------------------------------------
Patient Survey:                                   ..............  ..............  ..............  ..............
    Baseline Data Collection....................           3,600               1             .42           1,512
    6-Month Follow-up Data......................           2,880               1             .47           1,354
    Practitioner Survey.........................             261               1             .40             104
                                                 ---------------------------------------------------------------
        Total...................................           3,861  ..............  ..............           2,970
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by August 28, 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: July 20, 2006.
Anna Marsh,
Director, Office of Program Services.
 [FR Doc. E6-12028 Filed 7-26-06; 8:45 am]
BILLING CODE 4162-20-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.