81_FR_82009 81 FR 81786 - Notice of Joint Meeting by the Urology Interagency Coordinating Committee and the Diabetes Mellitus Interagency Coordinating Committee Meeting

81 FR 81786 - Notice of Joint Meeting by the Urology Interagency Coordinating Committee and the Diabetes Mellitus Interagency Coordinating Committee Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 223 (November 18, 2016)

Page Range81786-81787
FR Document2016-27825

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) and the Urology Interagency Coordinating Committee (UICC) will hold a joint meeting on December 16, 2016. The subject of the meeting will be ``The Urologic Complications of Diabetes.'' The meeting is open to the public.

Federal Register, Volume 81 Issue 223 (Friday, November 18, 2016) 
[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81786-81787]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of Joint Meeting by the Urology Interagency Coordinating 
Committee and the Diabetes Mellitus Interagency Coordinating Committee 
Meeting

SUMMARY: The Diabetes Mellitus Interagency Coordinating Committee 
(DMICC) and the Urology Interagency Coordinating Committee (UICC) will 
hold a joint meeting on December 16, 2016. The subject of the meeting 
will be ``The Urologic Complications of Diabetes.'' The meeting is open 
to the public.

DATES: The meeting will be held on December 16, 2016; from 9:00 a.m. to 
12:00 p.m. Individuals wanting to present oral comments must notify the 
contact person at least 10 days before the meeting date.

ADDRESSES: The meeting will be held in the Democracy 2 Building at 6707 
Democracy Blvd., Bethesda, MD, in Conference Room 7050.

FOR FURTHER INFORMATION CONTACT: For further information concerning 
this meeting, see the DMICC Web site, www.diabetescommittee.gov, or 
contact Dr. B. Tibor Roberts, Executive Secretary of the Diabetes 
Mellitus Interagency Coordinating Committee, National Institute of 
Diabetes and Digestive and Kidney Diseases, 31 Center Drive, Building 
31A, Room 9A19, MSC 2560, Bethesda, MD 20892-2560, telephone: 301-496-
6623; FAX: 301-480-6741; email: [email protected].

SUPPLEMENTARY INFORMATION: The DMICC and the UICC, both chaired by the 
National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK) comprising members of the Department of Health and Human 
Services and other federal agencies that support diabetes-related or 
urologic-related activities respectively, facilitate cooperation, 
communication, and collaboration on diabetes among government entities. 
The Committees' meetings, held several times a year, provide an 
opportunity for their members to learn about and discuss current and 
relevant future programs in their member organizations and to identify 
opportunities for collaboration. The December 16, 2016 joint meeting 
will focus on The Urologic Complications of Diabetes.
    Any member of the public interested in presenting oral comments to 
the Committees should notify the contact person listed on this notice 
at least 10 days in advance of the meeting. Interested individuals and 
representatives or organizations should submit a letter of intent, a 
brief description of the organization represented, and a written copy 
of their oral presentation in advance of the meeting. Only one 
representative of an organization will be allowed to present; oral 
comments and presentations will be limited to a maximum of 5 minutes. 
Printed and electronic copies are requested for the record. In 
addition, any interested person may file written comments with the 
Committees by forwarding their statement to the contact person listed 
on this notice. The statement should include the name, address, 
telephone number and when applicable, the business or professional 
affiliation of the interested person. Because of time constraints for 
the meeting, oral comments will be allowed on a first-come, first-serve 
basis.
    Members of the public who would like to receive email notification 
about

[[Page 81787]]

future DMICC meetings should register for the listserv available on the 
DMICC Web site, www.diabetescommittee.gov.

    Dated: November 9, 2016.
B. Tibor Roberts,
Executive Secretary, Office of Scientific Program and Policy Analysis, 
National Institute of Diabetes and Digestive and Kidney Diseases, 
National Institutes of Health.
[FR Doc. 2016-27825 Filed 11-17-16; 8:45 am]
 BILLING CODE 4140-01-P

81786 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices information you claim to be confidential Usual Names for Seafood in Interstate ADDRESSES: The meeting will be held in with a heading or cover note that states Commerce.’’ The draft CPG is intended the Democracy 2 Building at 6707 ‘‘THIS DOCUMENT CONTAINS to provide guidance for FDA staff Democracy Blvd., Bethesda, MD, in CONFIDENTIAL INFORMATION.’’ The regarding use of The Seafood List to Conference Room 7050. Agency will review this copy, including determine whether a seafood name is FOR FURTHER INFORMATION CONTACT: For the claimed confidential information, in acceptable. The draft CPG explains further information concerning this its consideration of comments. The when we may consider a seafood meeting, see the DMICC Web site, second copy, which will have the product to be misbranded under section www.diabetescommittee.gov, or contact claimed confidential information 403 of the Federal Food, Drug, and Dr. B. Tibor Roberts, Executive redacted/blacked out, will be available Cosmetic Act (21 U.S.C. 343). The draft Secretary of the Diabetes Mellitus for public viewing and posted on http:// CPG also contains information that may Interagency Coordinating Committee, www.regulations.gov. Submit both be useful to the regulated industry and National Institute of Diabetes and copies to the Division of Dockets to the public. Digestive and Kidney Diseases, 31 Management. If you do not wish your We are issuing this draft CPG Center Drive, Building 31A, Room name and contact information to be consistent with our good guidance 9A19, MSC 2560, Bethesda, MD 20892– made publicly available, you can practices regulation (21 CFR 10.115). 2560, telephone: 301–496–6623; FAX: provide this information on the cover The draft CPG, when finalized, will 301–480–6741; email: dmicc@ sheet and not in the body of your represent our current thinking on mail.nih.gov. comments and you must identify this acceptable names for seafood in SUPPLEMENTARY INFORMATION: The information as ‘‘confidential.’’ Any interstate commerce. It does not establish any rights for any person and DMICC and the UICC, both chaired by information marked as ‘‘confidential’’ the National Institute of Diabetes and will not be disclosed except in is not binding on FDA or the public. You can use an alternate approach if it Digestive and Kidney Diseases (NIDDK) accordance with 21 CFR 10.20 and other comprising members of the Department applicable disclosure law. For more satisfies the requirements of the applicable statutes and regulations. of Health and Human Services and other information about FDA’s posting of federal agencies that support diabetes- comments to public dockets, see 80 FR II. Electronic Access related or urologic-related activities 56469, September 18, 2015, or access respectively, facilitate cooperation, Persons with access to the Internet the information at: http://www.fda.gov/ communication, and collaboration on may obtain the draft CPG from FDA’s regulatoryinformation/dockets/ diabetes among government entities. Office of Regulatory Affairs CPG history default.htm. The Committees’ meetings, held several page at http://www.fda.gov/ICECI/ Docket: For access to the docket to times a year, provide an opportunity for ComplianceManuals/CompliancePolicy read background documents or the their members to learn about and GuidanceManual/default.htm or http:// electronic and written/paper comments discuss current and relevant future www.regulations.gov. Use the FDA Web received, go to http:// site listed in the previous sentence to programs in their member organizations www.regulations.gov and insert the find the most current version of the and to identify opportunities for docket number, found in brackets in the guidance. collaboration. The December 16, 2016 heading of this document, into the joint meeting will focus on The Urologic ‘‘Search’’ box and follow the prompts Dated: November 15, 2016. Leslie Kux, Complications of Diabetes. and/or go to the Division of Dockets Any member of the public interested Management, 5630 Fishers Lane, Rm. Associate Commissioner for Policy. in presenting oral comments to the 1061, Rockville, MD 20852. [FR Doc. 2016–27843 Filed 11–17–16; 8:45 am] Committees should notify the contact Submit written requests for single BILLING CODE 4164–01–P person listed on this notice at least 10 copies of the draft CPG to the Food and days in advance of the meeting. Feed Policy Staff, Office of Policy and Interested individuals and Risk Management, Office of Regulatory DEPARTMENT OF HEALTH AND representatives or organizations should Affairs, Food and Drug Administration, HUMAN SERVICES submit a letter of intent, a brief 12420 Parklawn Dr., Rockville, MD description of the organization 20857. Send two self-addressed National Institutes of Health represented, and a written copy of their adhesive labels to assist that office in Notice of Joint Meeting by the Urology oral presentation in advance of the processing your request. See the Interagency Coordinating Committee meeting. Only one representative of an SUPPLEMENTARY INFORMATION section for organization will be allowed to present; and the Diabetes Mellitus Interagency electronic access to the draft CPG. Coordinating Committee Meeting oral comments and presentations will be FOR FURTHER INFORMATION CONTACT: limited to a maximum of 5 minutes. Spring C. Randolph, Center for Food SUMMARY: The Diabetes Mellitus Printed and electronic copies are Safety and Applied Nutrition (HFC– Interagency Coordinating Committee requested for the record. In addition, 325), Food and Drug Administration, (DMICC) and the Urology Interagency any interested person may file written 5001 Campus Dr., College Park, MD Coordinating Committee (UICC) will comments with the Committees by 20740, 240–402–1421. hold a joint meeting on December 16, forwarding their statement to the SUPPLEMENTARY INFORMATION: 2016. The subject of the meeting will be contact person listed on this notice. The ‘‘The Urologic Complications of statement should include the name, I. Background Diabetes.’’ The meeting is open to the address, telephone number and when mstockstill on DSK3G9T082PROD with NOTICES We are announcing the availability of public. applicable, the business or professional the draft CPG entitled ‘‘Compliance DATES: The meeting will be held on affiliation of the interested person. Policy Guide Sec. 540.750 Use of The December 16, 2016; from 9:00 a.m. to Because of time constraints for the Seafood List to Determine Acceptable 12:00 p.m. Individuals wanting to meeting, oral comments will be allowed Seafood Names.’’ The draft CPG, if present oral comments must notify the on a first-come, first-serve basis. finalized, will update the previously contact person at least 10 days before Members of the public who would issued ‘‘CPG Sec. 540.750—Common or the meeting date. like to receive email notification about VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1

Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices 81787 future DMICC meetings should register lead molecules may be useful to treat Inventor(s): Amy Newman and Vivek for the listserv available on the DMICC drug addiction/dependence. Kumar (NIDA). Web site, www.diabetescommittee.gov. Description of Technology: Dopamine Intellectual Property: E–053–2016 Dated: November 9, 2016. is a major neurotransmitter in the United States Provisional Patent B. Tibor Roberts, central nervous system and among other Application No. 62/307,600, filed March functions is directly related to the 14, 2016, titled ‘‘Dopamine D3 Receptor Executive Secretary, Office of Scientific Program and Policy Analysis, National rewarding effects of drugs of abuse. Selective Antagonists/Partial Agonists; Institute of Diabetes and Digestive and Kidney Dopamine signaling is mediated by D1, Methods of Making and Use Thereof’’. Diseases, National Institutes of Health. D2, D3, D4 and D5 receptors. The Publications: J Med Chem. 2016 Aug [FR Doc. 2016–27825 Filed 11–17–16; 8:45 am] dopamine D3 receptor is a known target 25;59(16):7634–50. doi: 10.1021/ to treat a variety of neuropsychiatric acs.jmedchem.6b00860. Epub 2016 Aug BILLING CODE 4140–01–P disorders, including substance use 10. disorders (e.g. cocaine and opioid), Collaboration Opportunity: DEPARTMENT OF HEALTH AND schizophrenia and depression. Despite Researchers at the NIDA seek licensing HUMAN SERVICES extensive efforts, it has proven difficult and/or co-development research to identify a lead molecule that collaborations for development of National Institutes of Health selectively binds to D3 receptors (versus Dopamine D3 ligands to treat opioid use D2 receptors, for example), with the disorders. Government-Owned Inventions; desired pharmacological and Contact Information: Requests for Availability for Licensing and/or Co- pharmacokinetic profile. For example, copies of the patent application or Development metabolic instability or predicted inquiries about licensing, research toxicity has precluded successful collaborations, and co-development AGENCY: National Institutes of Health, opportunities should be sent to John D. Department of Health and Human translation of previously reported D3R- selective antagonists to clinical use for Hewes, Ph.D., email: john.hewes@ Services. nih.gov. ACTION: Notice. cocaine abuse. The library of compounds is designed Dated: November 10, 2016. SUMMARY: The invention listed below is to have high affinity and specificity for John D. Hewes, owned by an agency of the U.S. the dopamine D3 receptor. Preliminary Technology Transfer Specialist, Technology Government and is available for studies at National Institute of Drug Transfer Center, National Cancer Institute. licensing and/or co-development in the Abuse (NIDA) indicate that selected [FR Doc. 2016–27770 Filed 11–17–16; 8:45 am] U.S. to achieve expeditious lead compounds have promising in vivo BILLING CODE 4140–01–P commercialization of results of activity in rodents, including reduced federally-funded research and acquisition to self-administration of development. Foreign patent oxycodone, inhibition of reinstatement DEPARTMENT OF HEALTH AND applications are filed on selected to oxycodone seeking, and ameliorating HUMAN SERVICES inventions to extend market coverage naloxone-precipitated withdrawal from for companies and may also be available oxycodone dependence. National Institutes of Health for licensing and/or co-development. This invention is owned by an agency of the U.S. Government and is available Submission for OMB Review; 30-Day ADDRESSES: Invention Development and for licensing and/or co-development in Comment Request: A National Survey Marketing Unit, Technology Transfer the U.S., in accordance with 35 U.S.C. of Nurse Coaches (NIH Clinical Center) Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, 209 and 37 CFR part 404, to achieve AGENCY: National Institutes of Health. Rockville, MD 20850–9702. expeditious commercialization of ACTION: Notice. FOR FURTHER INFORMATION CONTACT: results of federally-funded research and Information on licensing and co- development. Foreign patent SUMMARY: In compliance with the development research collaborations, applications are filed on selected Paperwork Reduction Act of 1995, the and copies of the U.S. patent inventions to extend market coverage National Institutes of Health (NIH) has applications listed below may be for companies and may also be available submitted to the Office of Management obtained by contacting: Attn. Invention for licensing and/or co-development. and Budget (OMB) a request for review Development and Marketing Unit, Potential Commercial Applications: and approval of the information Technology Transfer Center, National • Treatment of Opioid Use Disorders collection listed below. This proposed Cancer Institute, 9609 Medical Center • Treatment of Schizophrenia information collection was previously Drive, Mail Stop 9702, Rockville, MD • Treatment of Bipolar Disorder published in the Federal Register on 20850–9702, Tel. 240–276–5515 or • Treatment of cannabis August 22, 2016, pages 56668–9 (81 FR email ncitechtransfer@mail.nih.gov. A (Tetrahydrocannabinol, THC) 56668) and allowed 60-days for public signed Confidential Disclosure dependence comment. No public comments were Agreement may be required to receive Value Proposition: Despite extensive received. The purpose of this notice is copies of the patent applications. efforts to develop D3 receptor-selective to allow an additional 30 days for public SUPPLEMENTARY INFORMATION: compounds, it has proven difficult to comment. Technology description follows. identify a ligand with the desired DATES: Comments regarding this Title of invention: Methods of Making pharmacological and pharmacokinetic information collection are best assured mstockstill on DSK3G9T082PROD with NOTICES and Using Dopamine D3 Receptor profile for translation to the clinic. The of having their full effect if received by Selective Antagonists/Partial Agonists D3 receptor ligands described herein December 19, 2016. Summary of Technology: A library of may be useful to treat a variety of ADDRESSES: Written comments and/or novel compounds that selectively bind diseases, including opioid use disorders suggestions regarding the item(s) the dopamine D3 receptor have been and schizophrenia. contained in this notice, especially designed and characterized extensively. Development Stage: Pre-clinical (in regarding the estimated public burden In vivo rodent studies indicate selected vivo validation). and associated response time, should be VerDate Sep<11>2014 20:21 Nov 17, 2016 Jkt 241001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1


Document Created: 2018-02-14 08:31:53
Document Modified: 2018-02-14 08:31:53
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
DatesThe meeting will be held on December 16, 2016; from 9:00 a.m. to 12:00 p.m. Individuals wanting to present oral comments must notify the contact person at least 10 days before the meeting date.
ContactFor further information concerning this meeting, see the DMICC Web site, www.diabetescommittee.gov, or contact Dr. B. Tibor Roberts, Executive Secretary of the Diabetes Mellitus Interagency Coordinating Committee, National Institute of Diabetes and Digestive and Kidney Diseases, 31 Center Drive, Building 31A, Room 9A19, MSC 2560, Bethesda, MD 20892-2560, telephone: 301-496- 6623; FAX: 301-480-6741; email: [email protected]
FR Citation81 FR 81786 
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