Meeting of the Pain Management Best Practices Inter-Agency Task Force; Amendment, 25469-25470 [2018-11747]

Download as PDF daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Lubna Merchant, Center for Drug VerDate Sep<11>2014 17:06 May 31, 2018 Jkt 244001 Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993–0002, 301– 796–5162, email: Lubna.Merchant@ fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Development of a Shared System REMS.’’ This guidance describes some of the possible benefits of shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs. Section 505–l(i)(l)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355–1((i)(1)(B)) requires that a holder of an abbreviated new drug application (ANDA) approved under section 505(j) use a ‘‘single, shared system’’ with the reference listed drug (RLD) for any REMS with elements to assure safe use (ETASU) unless FDA waives this requirement. The requirement under section 505– 1(i)(1)(B) regarding a ‘‘single, shared system’’ only applies to ANDAs. However, FDA recognizes that it may be in the interest of public health to have a shared system REMS in other cases because it may increase efficiencies for applicants and stakeholders. A shared system REMS can encompass multiple prescription drug products and can be developed and implemented jointly by two or more applicants. It can be a program shared by a drug that is the subject of an ANDA and the listed drug, as required in section 505–1(i)(1)(B) (described above). It can also involve multiple new drug applications, ANDAs, or biologics license applications, approved under section 505(b)(1), (b)(2), or (j) of the FD&C Act (21 U.S.C. 355(b)(1), (b)(2) or (j)) or section 351(a) or (k) of the PHS Act (42 U.S.C. 262(a) or (k)), respectively, that form a shared system voluntarily. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance entitled ‘‘Waivers of the Single, Shared System REMS Requirement.’’ Among other things, that guidance describes how FDA will consider granting a waiver of the requirement in section 505–1(i) of the FD&C Act that the applicant for an ANDA and its RLD use a single, shared system for REMS with ETASU. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 25469 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Development of a Shared System REMS.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520). The preparation and submission of a drug master file (as described in 21 CFR 314.420) by applicants for their shared system REMS submissions has been approved under OMB control number 0910–0001. In accordance with the PRA, before publication of the final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to previously approved collections of information found in FDA regulations. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or https:// www.regulations.gov. Dated: May 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–11783 Filed 5–31–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Pain Management Best Practices Inter-Agency Task Force; Amendment Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. AGENCY: ACTION: E:\FR\FM\01JNN1.SGM Notice; amendment. 01JNN1 25470 Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices A notice was published in the Federal Register on Thursday, May 3, 2018, to announce the inaugural meeting of the Pain Management Best Practices Inter-Agency Task Force (Task Force) and to invite the public to provide public comments. The period for written comments is currently scheduled to end close of business on May 25, 2018. The notice is being amended to extend the written public comment period for two weeks to allow more time for interested individuals to submit comments. DATES: The written public comment period has been extended. All written comments are due to be submitted on or before June 15, 2018. ADDRESSES: Individuals submitting written comments should submit their comments through the Federal eRulemaking Portal at https:// www.regulations.gov. SUMMARY: FOR FURTHER INFORMATION CONTACT: Alicia Richmond Scott, Designated Federal Official, Pain Management Best Practices Inter-Agency Task Force, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health, 200 Independence Avenue SW, Room 736E, Washington, DC 20201. Email: paintaskforce@ hhs.gov. Telephone: (240) 453–2816. Dated: May 24, 2018. Vanila M. Singh, Chief Medical Officer, HHS Office of the Assistant Secretary for Health. [FR Doc. 2018–11747 Filed 5–31–18; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHScertified laboratories and IITFs is published in the Federal Register daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:06 May 31, 2018 Jkt 244001 during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the 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 https://www.samhsa.gov/ workplace. FOR FURTHER INFORMATION CONTACT: Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240–276–2600 (voice). SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards 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); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); April 30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 7920). The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100–71. The ‘‘Mandatory Guidelines for Federal Workplace Drug Testing Programs,’’ as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies. To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 In accordance with the Mandatory Guidelines dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens: HHS-Certified Instrumented Initial Testing Facilities Dynacare, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780– 784–1190, (Formerly: GammaDynacare Medical Laboratories) HHS-Certified Laboratories ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 844–486–9226 Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504–361–8989/ 800–433–3823, (Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.) Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 804–378–9130, (Formerly: Kroll Laboratory Specialists, Inc., Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Inc.) Baptist Medical Center-Toxicology Laboratory, 11401 I–30, Little Rock, AR 72209–7056, 501–202–2783, (Formerly: Forensic Toxicology Laboratory Baptist Medical Center) Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS 66215– 2802, 800–445–6917 DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800– 235–4890 Dynacare,* 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519– * The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSAaccredited laboratories was transferred to the U.S. HHS, with the HHS’ NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do. Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on January 23, 2017 (82 FR 7920). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program. E:\FR\FM\01JNN1.SGM 01JNN1

Agencies

[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25469-25470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Pain Management Best Practices Inter-Agency Task 
Force; Amendment

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice; amendment.

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[[Page 25470]]

SUMMARY: A notice was published in the Federal Register on Thursday, 
May 3, 2018, to announce the inaugural meeting of the Pain Management 
Best Practices Inter-Agency Task Force (Task Force) and to invite the 
public to provide public comments. The period for written comments is 
currently scheduled to end close of business on May 25, 2018. The 
notice is being amended to extend the written public comment period for 
two weeks to allow more time for interested individuals to submit 
comments.

DATES: The written public comment period has been extended. All written 
comments are due to be submitted on or before June 15, 2018.

ADDRESSES: Individuals submitting written comments should submit their 
comments through the Federal eRulemaking Portal at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Alicia Richmond Scott, Designated 
Federal Official, Pain Management Best Practices Inter-Agency Task 
Force, U.S. Department of Health and Human Services, Office of the 
Assistant Secretary for Health, 200 Independence Avenue SW, Room 736E, 
Washington, DC 20201. Email: [email protected]. Telephone: (240) 
453-2816.

    Dated: May 24, 2018.
Vanila M. Singh,
Chief Medical Officer, HHS Office of the Assistant Secretary for 
Health.
[FR Doc. 2018-11747 Filed 5-31-18; 8:45 am]
BILLING CODE 4150-28-P
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