Agency Information Collection Activities: Submission for OMB Review; Comment Request, 75466-75467 [E5-7542]

Download as PDF 75466 Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Notices available to the public on the Internet at http://www.fda.gov/cdrh/meetings/ 012006workshop/index.html. This workshop helps fulfill the Department of Health and Human Services’ and FDA’s important mission to protect the public health by providing the medical device community with guidance on the approval process for mechanical circulatory support devices (ventricular assist devices) used in pediatric patients in need of temporary support (left side, right side, or both sides). During the public workshop, FDA will present information regarding the approval process for these devices. Specifically, FDA will address applications for premarket approval, humanitarian use designations, humanitarian device exemptions, and investigational device exemptions. FDA will also present information regarding preclinical engineering qualification of pediatric mechanical circulatory support devices and invited experts will discuss medical and surgical topics. Following each presentation, and at the close of the meeting, FDA will conduct a question and answer session with the participating audience. After the workshop, presentations can be accessed by the public on the Internet at http://www.fda.gov/cdrh/meetings/ 012006workshop/index.html. This workshop helps to implement the objectives of section 406 of the FDA Modernization Act (21 U.S.C. 393) and the FDA Plan for Statutory Compliance, which include 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. SUPPLEMENTARY INFORMATION: Dated: December 12, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05–24271 Filed 12–19–05; 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. Notification of Intent To Use Schedule III, IV, or V Opioid Drugs for the Maintenance and Detoxification Treatment of Opiate Addiction Under 21 U.S.C. 823(g)(2) (OMB No. 0930– 0234)—Revision The Drug Addiction Treatment Act of 2000 (‘‘DATA,’’ Pub. L. 106–310) amended the Controlled Substances Act (21 U.S.C. 823(g)(2)) to permit practitioners (physicians) to seek and obtain waivers to prescribe certain approved narcotic treatment drugs for the treatment of opiate addiction. The legislation sets eligibility requirements and certification requirements as well as an interagency notification review process for physicians who seek waivers. To implement these new provisions, SAMHSA developed a notification form (SMA–167) that facilitates the submission and review of notifications. The form provides the information necessary to determine whether practitioners (i.e., independent physicians and physicians in group practices (as defined under section 1877(h)(4) of the Social Security Act) meet the qualifications for waivers set forth under the new law. Use of this form will enable physicians to know they have provided all information needed to determine whether practitioners are eligible for a waiver. However, there is no prohibition on use of other means to provide requisite information. The Secretary will convey notification information and determinations to the Drug Enforcement Administration (DEA), which will Number of respondents Purpose of submission Initial Application for Waiver ............................................................................ Notification to Prescribe Immediately .............................................................. VerDate Aug<31>2005 19:23 Dec 19, 2005 Jkt 208001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 assign an identification number to qualifying practitioners; this number will be included in the practitioner’s registration under 21 U.S.C. 823(f). Practitioners may use the form for two types of notification: (a) New, and (b) immediate. Under ‘‘new’’ notifications, practitioners may make their initial waiver requests to SAMHSA. ‘‘Immediate’’ notifications inform SAMHSA and the Attorney General of a practitioner’s intent to prescribe immediately to facilitate the treatment of an individual (one) patient under 21 U.S.C. 823(g)(2)(E)(ii). The form collects data on the following items: Practitioner name; state medical license number and DEA registration number; address of primary location, telephone and fax numbers; email address; name and address of group practice; group practice employer identification number; names and DEA registration numbers of group practitioners; purpose of notification new, immediate, or renewal; certification of qualifying criteria for treatment and management of opiate dependent patients; certification of capacity to refer patients for appropriate counseling and other appropriate ancillary services; certification of maximum patient load, certification to use only those drug products that meet the criteria in the law. The form also notifies practitioners of Privacy Act considerations, and permits practitioners to expressly consent to disclose limited information available on http:// www.buprenorphine.samhsa.gov. Since July 2002, SAMHSA has received approximately 6,400 notifications and has certified over 5,500 physicians. Eighty-one percent of the notifications were submitted by mail or by facsimile, with approximately twenty percent submitted through the Web based online system. Approximately 60 percent of the certified physicians have consented to disclosure on http:// www.buprenorphine.samhsa.gov. Respondents may submit the form electronically, through a dedicated Web page that SAMHSA will establish for the purpose, as well as via U.S. mail. The following table summarizes the estimated annual burden for the use of this form. Responses per respondent 2,000 50 E:\FR\FM\20DEN1.SGM Burden per response (hr.) 1 1 20DEN1 .066 .083 Total burden (hrs) 132 3 Federal Register / Vol. 70, No. 243 / Tuesday, December 20, 2005 / Notices Total .......................................................................................................... Written comments and recommendations concerning the proposed information collection should be sent by January 19, 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: December 14, 2005. Anna Marsh, Director, Office of Program Services. [FR Doc. E5–7542 Filed 12–19–05; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: SUMMARY: The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory’s certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the VerDate Aug<31>2005 19:23 Dec 19, 2005 Jkt 208001 Responses per respondent Burden per response (hr.) ........................ ........................ Number of respondents Purpose of submission 2,050 past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http://workplace.samhsa.gov and http://www.drugfreeworkplace.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh or Dr. Walter Vogl, Division of Workplace Programs, SAMHSA/CSAP, Room 2–1035, 1 Choke Cherry Road, Rockville, Maryland 20857; 240–276–2600 (voice), 240–276– 2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were developed in accordance with Executive Order 12564 and section 503 of Public Law 100–71. Subpart C of the Mandatory Guidelines, ‘‘Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,’’ sets strict standards that laboratories must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A laboratory must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards. In accordance with Subpart C of the Mandatory Guidelines dated April 13, 2004 (69 FR 19644), the following laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens: ACL Laboratories, 8901 W. Lincoln Ave., West Allis, WI 53227, 414–328– 7840 / 800–877–7016, (Formerly: Bayshore Clinical Laboratory) ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 585–429–2264 Advanced Toxicology Network, 3560 Air Center Cove, Suite 101, Memphis, TN 38118, 901–794–5770 / 888–290– 1150 Aegis Analytical Laboratories, Inc., 345 Hill Ave., Nashville, TN 37210, 615– 255–2400 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 75467 Total burden (hrs) 135 Baptist Medical Center-Toxicology Laboratory, 9601 I–630, Exit 7, Little Rock, AR 72205–7299, 501–202–2783, (Formerly: Forensic Toxicology Laboratory Baptist Medical Center) Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215–2802, 800– 445–6917 Diagnostic Services, Inc., dba DSI, 12700 Westlinks Drive, Fort Myers, FL 33913, 239–561–8200 / 800–735– 5416 Doctors Laboratory, Inc., 2906 Julia Drive, Valdosta, GA 31602, 229–671– 2281 DrugScan, Inc., P.O. Box 2969, 1119 Mearns Road, Warminster, PA 18974, 215–674–9310 Dynacare Kasper Medical Laboratories *, 10150–102 St., Suite 200, Edmonton, Alberta, Canada T5J 5E2, 780–451– 3702 / 800–661–9876 ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662– 236–2609 Express Analytical Labs, 3405 7th Ave., Suite 106, Marion, IA 52302, 319– 377–0500 Gamma-Dynacare Medical Laboratories *, A Division of the Gamma-Dynacare, Laboratory Partnership, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519– 679–1630 General Medical Laboratories, 36 South Brooks St., Madison, WI 53715, 608– 267–6225 Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040, 713–856–8288 / 800–800–2387 Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908–526–2400 / 800–437– 4986, (Formerly: Roche Biomedical Laboratories, Inc.) Laboratory Corporation of America Holdings, 1904 Alexander Drive, Research Triangle Park, NC 27709, 919–572–6900 / 800–833–3984, (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group) Laboratory Corporation of America Holdings,10788 Roselle St., San Diego, CA 92121, 800–882–7272 (Formerly: Poisonlab, Inc.) E:\FR\FM\20DEN1.SGM 20DEN1

Agencies

[Federal Register Volume 70, Number 243 (Tuesday, December 20, 2005)]
[Notices]
[Pages 75466-75467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7542]


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

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.

Notification of Intent To Use Schedule III, IV, or V Opioid Drugs for 
the Maintenance and Detoxification Treatment of Opiate Addiction Under 
21 U.S.C. 823(g)(2) (OMB No. 0930-0234)--Revision

    The Drug Addiction Treatment Act of 2000 (``DATA,'' Pub. L. 106-
310) amended the Controlled Substances Act (21 U.S.C. 823(g)(2)) to 
permit practitioners (physicians) to seek and obtain waivers to 
prescribe certain approved narcotic treatment drugs for the treatment 
of opiate addiction. The legislation sets eligibility requirements and 
certification requirements as well as an interagency notification 
review process for physicians who seek waivers.
    To implement these new provisions, SAMHSA developed a notification 
form (SMA-167) that facilitates the submission and review of 
notifications. The form provides the information necessary to determine 
whether practitioners (i.e., independent physicians and physicians in 
group practices (as defined under section 1877(h)(4) of the Social 
Security Act) meet the qualifications for waivers set forth under the 
new law. Use of this form will enable physicians to know they have 
provided all information needed to determine whether practitioners are 
eligible for a waiver.
    However, there is no prohibition on use of other means to provide 
requisite information. The Secretary will convey notification 
information and determinations to the Drug Enforcement Administration 
(DEA), which will assign an identification number to qualifying 
practitioners; this number will be included in the practitioner's 
registration under 21 U.S.C. 823(f).
    Practitioners may use the form for two types of notification: (a) 
New, and (b) immediate. Under ``new'' notifications, practitioners may 
make their initial waiver requests to SAMHSA. ``Immediate'' 
notifications inform SAMHSA and the Attorney General of a 
practitioner's intent to prescribe immediately to facilitate the 
treatment of an individual (one) patient under 21 U.S.C. 
823(g)(2)(E)(ii).
    The form collects data on the following items: Practitioner name; 
state medical license number and DEA registration number; address of 
primary location, telephone and fax numbers; e-mail address; name and 
address of group practice; group practice employer identification 
number; names and DEA registration numbers of group practitioners; 
purpose of notification new, immediate, or renewal; certification of 
qualifying criteria for treatment and management of opiate dependent 
patients; certification of capacity to refer patients for appropriate 
counseling and other appropriate ancillary services; certification of 
maximum patient load, certification to use only those drug products 
that meet the criteria in the law. The form also notifies practitioners 
of Privacy Act considerations, and permits practitioners to expressly 
consent to disclose limited information available on http://
www.buprenorphine.samhsa.gov.
    Since July 2002, SAMHSA has received approximately 6,400 
notifications and has certified over 5,500 physicians. Eighty-one 
percent of the notifications were submitted by mail or by facsimile, 
with approximately twenty percent submitted through the Web based 
online system. Approximately 60 percent of the certified physicians 
have consented to disclosure on http://www.buprenorphine.samhsa.gov.
    Respondents may submit the form electronically, through a dedicated 
Web page that SAMHSA will establish for the purpose, as well as via 
U.S. mail.
    The following table summarizes the estimated annual burden for the 
use of this form.

----------------------------------------------------------------------------------------------------------------
                                                                                    Burden per
              Purpose of submission                  Number of     Responses per     response      Total burden
                                                    respondents     respondent         (hr.)           (hrs)
----------------------------------------------------------------------------------------------------------------
Initial Application for Waiver..................           2,000               1            .066             132
Notification to Prescribe Immediately...........              50               1            .083               3
                                                 -----------------

[[Page 75467]]

 
    Total.......................................           2,050  ..............  ..............             135
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by January 19, 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: December 14, 2005.
Anna Marsh,
Director, Office of Program Services.
 [FR Doc. E5-7542 Filed 12-19-05; 8:45 am]
BILLING CODE 4162-20-P