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Federal Register/Vol. 82, No. 7/Wednesday, January 11, 2017 3326 Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices is responsible for oversight and DEPARTMENT OF HEALTH AND such as medical information, your or implementation of the MSP provisions HUMAN SERVICES anyone else’s Social Security number, or as part of its overall authority for the confidential business information, such Medicare program. The CMS Food and Drug Administration as a manufacturing process. Please note accomplishes this through a [Docket No. FDA–2016–N–4619] that if you include your name, contact combination of direct CMS action and information, or other information that work by CMS’ contractors. The CMS International Drug Scheduling; identifies you in the body of your efforts include policy and operational Convention on Psychotropic comments, that information will be guidelines, including regulations (as Substances; Single Convention on posted on https://www.regulations.gov. • If you want to submit a comment necessary), as well as oversight over Narcotic Drugs; World Health with confidential information that you contractor MSP responsibilities. As a Organization; Scheduling Recommendations; 4- do not wish to be made available to the result of litigation in the mid-1990’s, public, submit the comment as a certain GHP insurers were mandated to Methylethcathinone and Nine Other Substances; Request for Comments written/paper submission and in the report coverage information for a manner detailed (see ‘‘Written/Paper number of years. Subsequent to this AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). litigation related mandatory reporting, HHS. Written/Paper Submissions CMS instituted a Voluntary Data ACTION: Notice. Sharing Agreement (VDSA) effort which Submit written/paper submissions as expanded the scope of the GHP SUMMARY: The Food and Drug follows: • participants and added some NGHP Administration (FDA) is providing Mail/Hand delivery/Courier (for participants. This VDSA process interested persons with the opportunity written/paper submissions): Division of complemented the IRS/SSA/CMS Data to submit written comments, and to Dockets Management (HFA–305), Food Match reporting by employers, but request an informal public meeting and Drug Administration, 5630 Fishers concerning recommendations by the Lane, Rm. 1061, Rockville, MD 20852. clearly did not include the universe of • For written/paper comments primary payers and had few NGHP World Health Organization (WHO) to impose international manufacturing and submitted to the Division of Dockets participants. Both GHP and NGHP Management, FDA will post your entities have had and continue to have distributing restrictions, under international treaties, on certain drug comment, as well as any attachments, the responsibility for determining when except for information submitted, they are primary to Medicare and to pay substances. The comments received in response to this notice and/or public marked and identified, as confidential, appropriately, even without the meeting will be considered in preparing if submitted as detailed in mandatory Section 111 process. In order the United States’ position on these ‘‘Instructions.’’ to make this determination, they should proposals for a meeting of the United Instructions: All submissions received already and always be collecting most of Nations Commission on Narcotic Drugs must include the Docket No. FDA– the information CMS will require in (CND) in Vienna, Austria, in March 2016–N–4619 for ‘‘International Drug connection with Section 111 of the 2017. This notice is issued under the Scheduling; Convention on MMSEA. Section 111 establishes Controlled Substances Act (CSA). Psychotropic Substances; Single separate mandatory reporting Convention on Narcotic Drugs; World DATES: Submit either electronic or Health Organization; Scheduling requirements for GHP arrangements as written comments by February 10, 2017. well as for liability insurance (including Recommendations; 4- Submit requests for a public meeting on Methylethcathinone and Nine Other self-insurance), no-fault insurance, and or before January 23, 2017. The short workers’ compensation, these may Substances; Request for Comments.’’ time period for the submission of Received comments will be placed in collectively be referred to as ‘‘Non-GHP comments and requests for a public or NGHP.’’ Form Number: CMS–10265 the docket and, except for those meeting is needed to ensure that HHS submitted as ‘‘Confidential (OMB control number: 0938–1074); may, in a timely fashion, carry out the Submissions,’’ publicly viewable at Frequency: Yearly, Quarterly; Affected required action and be responsive to the https://www.regulations.gov or at the Public: Private Sector (Business or other United Nations. For additional Division of Dockets Management for-profits); Number of Respondents: information, see section IV of this between 9 a.m. and 4 p.m., Monday 19,248; Total Annual Responses: document. through Friday. 5,019,248; Total Annual Hours: 557,826. ADDRESSES: You may submit comments • Confidential Submissions—To (For policy questions regarding this as follows: submit a comment with confidential collection contact John Albert at 410– information that you do not wish to be 786–7457.) Electronic Submissions made publicly available, submit your Dated: January 5, 2017. Submit electronic comments in the comments only as a written/paper William N. Parham, III, following way: submission. You should submit two • Federal eRulemaking Portal: copies total. One copy will include the Director, Paperwork Reduction Staff, Office https://www.regulations.gov. Follow the information you claim to be confidential of Strategic Operations and Regulatory instructions for submitting comments. with a heading or cover note that states Affairs. Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS [FR Doc. 2017–00298 Filed 1–10–17; 8:45 am] including attachments, to https:// CONFIDENTIAL INFORMATION.’’ The BILLING CODE 4120–01–P www.regulations.gov will be posted to Agency will review this copy, including the docket unchanged. Because your the claimed confidential information, in comment will be made public, you are its consideration of comments. The solely responsible for ensuring that your second copy, which will have the comment does not include any claimed confidential information confidential information that you or a redacted/blacked out, will be available third party may not wish to be posted, for public viewing and posted on VerDate Sep<11>2014 19:05 Jan 10, 2017 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\11JAN1.SGM 11JAN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices 3327 https://www.regulations.gov. Submit discussions and negotiations relating to Secretary of State of the United States of both copies to the Division of Dockets the proposal. America and has the honour to inform the Management. If you do not wish your As detailed in the following Government that the Director-General of the name and contact information to be paragraphs, the Secretary of State has World Health Organization (WHO), pursuant received notification from the Secretary- to article 3, paragraphs 1 and 3 of the Single made publicly available, you can Convention on Narcotic Drugs of 1961 as provide this information on the cover General of the United Nations (the amended by the 1972 Protocol (1961 sheet and not in the body of your Secretary-General) regarding eight Convention) and article 2, paragraphs 1 and comments and you must identify this substances to be considered for control 4 of the Convention on Psychotropic information as ‘‘confidential.’’ Any under the Psychotropic Convention. Substances of 1971 (1971 Convention) information marked as ‘‘confidential’’ This notification reflects the notified the Secretary-General of the will not be disclosed except in recommendation from the 38th WHO following recommendations: accordance with 21 CFR 10.20 and other Expert Committee for Drug Dependence Substances recommended to be placed in Schedule I of the Single Convention on applicable disclosure law. For more (ECDD), which met in November 2016. In the Federal Register of September 19, Narcotic Drugs (1961), as amended by the information about FDA’s posting of 1972 Protocol: 2016 (81 FR 64162), FDA announced the comments to public dockets, see 80 FR —U–4770 56469, September 18, 2015, or access WHO ECDD review and invited interested persons to submit chemical name: 3,4-dichloro-N-(2- the information at: http://www.fda.gov/ dimethylamino-cyclohexyl)-N-methyl- regulatoryinformation/dockets/ information for WHO’s consideration. benzamide default.htm. The full text of the notification from —butyrfentanyl the Secretary-General is provided in chemical name: N-phenyl-N-[1-(2- Docket: For access to the docket to section II of this document. Section read background documents or the phenylethyl)-4-piperidinyl]butanamide 201(d)(2)(B) of the CSA requires the Substances recommended to be placed in electronic and written/paper comments Secretary of HHS, after receiving a received, go to https:// Schedule II of the 1971 Convention: notification proposing scheduling, to —4–MEC (4-methylethcathinone) www.regulations.gov and insert the publish a notice in the Federal Register docket number, found in brackets in the chemical name: 2-(ethylamino)-1-(4- to provide the opportunity for interested methylphenyl)propan-1-one heading of this document, into the persons to submit information and —ethylone ‘‘Search’’ box and follow
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