83_FR_25575 83 FR 25469 - Meeting of the Pain Management Best Practices Inter-Agency Task Force; Amendment

83 FR 25469 - Meeting of the Pain Management Best Practices Inter-Agency Task Force; Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 106 (June 1, 2018)

Page Range25469-25470
FR Document2018-11747

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.

Federal Register, Volume 83 Issue 106 (Friday, June 1, 2018) 
[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25469-25470]
From the Federal Register Online  [www.thefederalregister.org]
[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 http://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

Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices 25469 ‘‘Confidential Submissions,’’ publicly Evaluation and Research, Food and This draft guidance is being issued viewable at https://www.regulations.gov Drug Administration, 10903 New consistent with FDA’s good guidance or at the Dockets Management Staff Hampshire Ave., Bldg. 22, Rm. 4418, practices regulation (21 CFR 10.115). between 9 a.m. and 4 p.m., Monday Silver Spring, MD 20993–0002, 301– The draft guidance, when finalized, will through Friday. 796–5162, email: Lubna.Merchant@ represent the current thinking of FDA • Confidential Submissions—To fda.hhs.gov; or Stephen Ripley, Center on ‘‘Development of a Shared System submit a comment with confidential for Biologics Evaluation and Research, REMS.’’ It does not establish any rights information that you do not wish to be Food and Drug Administration, 10903 for any person and is not binding on made publicly available, submit your New Hampshire Ave., Bldg. 71, Rm. FDA or the public. You can use an comments only as a written/paper 7301, Silver Spring, MD 20993–0002, alternative approach if it satisfies the submission. You should submit two 240–402–7911. requirements of the applicable statutes copies total. One copy will include the SUPPLEMENTARY INFORMATION: and regulations. This guidance is not information you claim to be confidential subject to Executive Order 12866. with a heading or cover note that states I. Background ‘‘THIS DOCUMENT CONTAINS II. Paperwork Reduction Act of 1995 FDA is announcing the availability of CONFIDENTIAL INFORMATION.’’ The a draft guidance for industry entitled This draft guidance refers to Agency will review this copy, including ‘‘Development of a Shared System collections of information that are the claimed confidential information, in REMS.’’ This guidance describes some subject to review by the Office of its consideration of comments. The of the possible benefits of shared system Management and Budget (OMB) under second copy, which will have the REMS, and provides general principles the Paperwork Reduction Act of 1995 claimed confidential information and recommendations to assist industry (PRA) (44 U.S.C. 3501–3520). The redacted/blacked out, will be available with the development of these preparation and submission of a drug for public viewing and posted on programs. master file (as described in 21 CFR https://www.regulations.gov. Submit 314.420) by applicants for their shared Section 505–l(i)(l)(B) of the Federal both copies to the Dockets Management system REMS submissions has been Food, Drug, and Cosmetic Act (FD&C Staff. If you do not wish your name and approved under OMB control number Act) (21 U.S.C. 355–1((i)(1)(B)) requires contact information to be made publicly 0910–0001. In accordance with the PRA, that a holder of an abbreviated new drug available, you can provide this before publication of the final guidance application (ANDA) approved under information on the cover sheet and not document, FDA intends to solicit public section 505(j) use a ‘‘single, shared in the body of your comments and you comment and obtain OMB approval for system’’ with the reference listed drug must identify this information as (RLD) for any REMS with elements to any information collections ‘‘confidential.’’ Any information marked assure safe use (ETASU) unless FDA recommended in this guidance that are as ‘‘confidential’’ will not be disclosed waives this requirement. new or that would represent material except in accordance with 21 CFR 10.20 The requirement under section 505– modifications to previously approved and other applicable disclosure law. For 1(i)(1)(B) regarding a ‘‘single, shared collections of information found in FDA more information about FDA’s posting system’’ only applies to ANDAs. regulations. of comments to public dockets, see 80 FR 56469, September 18, 2015, or access However, FDA recognizes that it may be III. Electronic Access the information at: https://www.gpo.gov/ in the interest of public health to have fdsys/pkg/FR-2015-09-18/pdf/2015- a shared system REMS in other cases Persons with access to the internet 23389.pdf. because it may increase efficiencies for may obtain the draft guidance at either Docket: For access to the docket to applicants and stakeholders. A shared http://www.fda.gov/Drugs/ read background documents or the system REMS can encompass multiple GuidanceCompliance electronic and written/paper comments prescription drug products and can be RegulatoryInformation/Guidances/ received, go to https:// developed and implemented jointly by default.htm, https://www.fda.gov/ www.regulations.gov and insert the two or more applicants. It can be a BiologicsBloodVaccines/Guidance docket number, found in brackets in the program shared by a drug that is the ComplianceRegulatoryInformation/ heading of this document, into the subject of an ANDA and the listed drug, Guidances/default.htm, or https:// ‘‘Search’’ box and follow the prompts as required in section 505–1(i)(1)(B) www.regulations.gov. and/or go to the Dockets Management (described above). It can also involve Dated: May 24, 2018. Staff, 5630 Fishers Lane, Rm. 1061, multiple new drug applications, Leslie Kux, Rockville, MD 20852. ANDAs, or biologics license Associate Commissioner for Policy. You may submit comments on any applications, approved under section [FR Doc. 2018–11783 Filed 5–31–18; 8:45 am] guidance at any time (see 21 CFR 505(b)(1), (b)(2), or (j) of the FD&C Act (21 U.S.C. 355(b)(1), (b)(2) or (j)) or BILLING CODE 4164–01–P 10.115(g)(5)). Submit written requests for single section 351(a) or (k) of the PHS Act (42 copies of the draft guidance to the U.S.C. 262(a) or (k)), respectively, that Division of Drug Information, Center for DEPARTMENT OF HEALTH AND form a shared system voluntarily. Drug Evaluation and Research, Food HUMAN SERVICES Elsewhere in this issue of the Federal and Drug Administration, 10001 New Register, FDA is announcing the Meeting of the Pain Management Best Hampshire Ave., Hillandale Building, availability of a draft guidance entitled Practices Inter-Agency Task Force; 4th Floor, Silver Spring, MD 20993– ‘‘Waivers of the Single, Shared System Amendment daltland on DSKBBV9HB2PROD with NOTICES 0002. Send one self-addressed adhesive REMS Requirement.’’ Among other label to assist that office in processing things, that guidance describes how AGENCY: Office of the Assistant your requests. See the SUPPLEMENTARY FDA will consider granting a waiver of Secretary for Health, Office of the INFORMATION section for electronic the requirement in section 505–1(i) of Secretary, Department of Health and access to the draft guidance document. the FD&C Act that the applicant for an Human Services. FOR FURTHER INFORMATION CONTACT: ANDA and its RLD use a single, shared ACTION: Notice; amendment. Lubna Merchant, Center for Drug system for REMS with ETASU. VerDate Sep<11>2014 17:06 May 31, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1

25470 Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices SUMMARY: A notice was published in the during the first week of each month. If In accordance with the Mandatory Federal Register on Thursday, May 3, any laboratory or IITF certification is Guidelines dated January 23, 2017 (82 2018, to announce the inaugural suspended or revoked, the laboratory or FR 7920), the following HHS-certified meeting of the Pain Management Best IITF will be omitted from subsequent laboratories and IITFs meet the Practices Inter-Agency Task Force (Task lists until such time as it is restored to minimum standards to conduct drug Force) and to invite the public to full certification under the Mandatory and specimen validity tests on urine provide public comments. The period Guidelines. specimens: for written comments is currently If any laboratory or IITF has withdrawn from the HHS National HHS-Certified Instrumented Initial scheduled to end close of business on Laboratory Certification Program (NLCP) Testing Facilities May 25, 2018. The notice is being amended to extend the written public during the past month, it will be listed Dynacare, 6628 50th Street NW, comment period for two weeks to allow at the end and will be omitted from the Edmonton, AB Canada T6B 2N7, 780– more time for interested individuals to monthly listing thereafter. 784–1190, (Formerly: Gamma- submit comments. This notice is also available on the Dynacare Medical Laboratories) DATES: The written public comment internet at http://www.samhsa.gov/ workplace. HHS-Certified Laboratories period has been extended. All written comments are due to be submitted on or FOR FURTHER INFORMATION CONTACT: ACM Medical Laboratory, Inc., 160 before June 15, 2018. Giselle Hersh, Division of Workplace Elmgrove Park, Rochester, NY 14624, ADDRESSES: Individuals submitting Programs, SAMHSA/CSAP, 5600 844–486–9226 written comments should submit their Fishers Lane, Room 16N03A, Rockville, Alere Toxicology Services, 1111 Newton comments through the Federal Maryland 20857; 240–276–2600 (voice). St., Gretna, LA 70053, 504–361–8989/ eRulemaking Portal at http:// SUPPLEMENTARY INFORMATION: The 800–433–3823, (Formerly: Kroll www.regulations.gov. Department of Health and Human Laboratory Specialists, Inc., Services (HHS) notifies federal agencies Laboratory Specialists, Inc.) FOR FURTHER INFORMATION CONTACT: of the laboratories and Instrumented Alere Toxicology Services, 450 Alicia Richmond Scott, Designated Southlake Blvd., Richmond, VA Federal Official, Pain Management Best Initial Testing Facilities (IITF) currently certified to meet the standards of the 23236, 804–378–9130, (Formerly: Practices Inter-Agency Task Force, U.S. Kroll Laboratory Specialists, Inc., Department of Health and Human Mandatory Guidelines for Federal Workplace Drug Testing Programs Scientific Testing Laboratories, Inc.; Services, Office of the Assistant Kroll Scientific Testing Laboratories, Secretary for Health, 200 Independence (Mandatory Guidelines). The Mandatory Guidelines were first published in the Inc.) Avenue SW, Room 736E, Washington, Federal Register on April 11, 1988 (53 Baptist Medical Center-Toxicology DC 20201. Email: paintaskforce@ FR 11970), and subsequently revised in Laboratory, 11401 I–30, Little Rock, hhs.gov. Telephone: (240) 453–2816. the Federal Register on June 9, 1994 (59 AR 72209–7056, 501–202–2783, Dated: May 24, 2018. FR 29908); September 30, 1997 (62 FR (Formerly: Forensic Toxicology Vanila M. Singh, 51118); April 13, 2004 (69 FR 19644); Laboratory Baptist Medical Center) Chief Medical Officer, HHS Office of the November 25, 2008 (73 FR 71858); Clinical Reference Laboratory, Inc., 8433 Assistant Secretary for Health. December 10, 2008 (73 FR 75122); April Quivira Road, Lenexa, KS 66215– [FR Doc. 2018–11747 Filed 5–31–18; 8:45 am] 30, 2010 (75 FR 22809); and on January 2802, 800–445–6917 BILLING CODE 4150–28–P 23, 2017 (82 FR 7920). DrugScan, Inc., 200 Precision Road, The Mandatory Guidelines were Suite 200, Horsham, PA 19044, 800– initially developed in accordance with 235–4890 DEPARTMENT OF HEALTH AND Executive Order 12564 and section 503 Dynacare,* 245 Pall Mall Street, HUMAN SERVICES of Public Law 100–71. The ‘‘Mandatory London, ONT, Canada N6A 1P4, 519– Guidelines for Federal Workplace Drug Substance Abuse and Mental Health Testing Programs,’’ as amended in the * The Standards Council of Canada (SCC) voted Services Administration revisions listed above, requires strict to end its Laboratory Accreditation Program for standards that laboratories and IITFs Substance Abuse (LAPSA) effective May 12, 1998. Current List of HHS-Certified Laboratories certified through that program were must meet in order to conduct drug and Laboratories and Instrumented Initial accredited to conduct forensic urine drug testing as specimen validity tests on urine required by U.S. Department of Transportation Testing Facilities Which Meet Minimum specimens for federal agencies. (DOT) regulations. As of that date, the certification Standards To Engage in Urine Drug of those accredited Canadian laboratories will To become certified, an applicant Testing for Federal Agencies continue under DOT authority. The responsibility laboratory or IITF must undergo three for conducting quarterly performance testing plus AGENCY: Substance Abuse and Mental rounds of performance testing plus an periodic on-site inspections of those LAPSA- Health Services Administration, HHS. on-site inspection. To maintain that accredited laboratories was transferred to the U.S. certification, a laboratory or IITF must HHS, with the HHS’ NLCP contractor continuing to ACTION: Notice. have an active role in the performance testing and participate in a quarterly performance laboratory inspection processes. Other Canadian SUMMARY: The Department of Health and testing program plus undergo periodic, laboratories wishing to be considered for the NLCP Human Services (HHS) notifies federal on-site inspections. may apply directly to the NLCP contractor just as agencies of the laboratories and Laboratories and IITFs in the U.S. laboratories do. Instrumented Initial Testing Facilities applicant stage of certification are not to Upon finding a Canadian laboratory to be daltland on DSKBBV9HB2PROD with NOTICES qualified, HHS will recommend that DOT certify (IITF) currently certified to meet the be considered as meeting the minimum the laboratory (Federal Register, July 16, 1996) as standards of the Mandatory Guidelines requirements described in the HHS meeting the minimum standards of the Mandatory for Federal Workplace Drug Testing Mandatory Guidelines. A HHS-certified Guidelines published in the Federal Register on Programs (Mandatory Guidelines). laboratory or IITF must have its letter of January 23, 2017 (82 FR 7920). After receiving DOT certification, the laboratory will be included in the A notice listing all currently HHS- certification from HHS/SAMHSA monthly list of HHS-certified laboratories and certified laboratories and IITFs is (formerly: HHS/NIDA), which attests participate in the NLCP certification maintenance published in the Federal Register that it has met minimum standards. program. VerDate Sep<11>2014 17:06 May 31, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1


Document Created: 2018-06-01 01:30:08
Document Modified: 2018-06-01 01:30:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; amendment.
DatesThe written public comment period has been extended. All written comments are due to be submitted on or before June 15, 2018.
ContactAlicia 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.
FR Citation83 FR 25469 
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