Center for Scientific Review; Notice of Closed Meetings, 51637-51638 [2017-24143]

Download as PDF Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices include patients with clinical or laboratory evidence of chronic hepatitis C disease, such as the presence of fibrosis by biopsy or noninvasive tests. • Additional details on DAA drug development in patients with decompensated cirrhosis, including recommendations for a review by an independent adjudication committee for all serious hepatic events, deaths, liver transplantations, and changes in prespecified alanine transaminase, aspartate transaminase, and bilirubin parameters and a recommendation for long-term followup to characterize clinical outcomes such as progression or regression of liver disease, liver-related mortality, occurrence of hepatocellular carcinoma, or liver failure requiring liver transplantation. • Additional clarification on efficacy endpoints, specifically additional posttreatment followup (e.g., 1 year or longer) may be needed if one or more drugs in the regimen has a long plasma or intracellular half-life or prolonged antiviral activity. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Chronic Hepatitis C Virus Infection: Developing DirectActing Antiviral Drugs for Treatment.’’ 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. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following Heart, Lung, & Blood Program Project Review Committee meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Heart, Lung, and Blood Initial Review Group; Heart, Lung, and Blood Program Project Review Committee. Date: December 1, 2017. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton BWI (Baltimore), 1100 Old Elkridge Landing Road, Baltimore, MD 21090. Contact Person: Jeffrey H. Hurst, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7208, Bethesda, MD 20892, 301–435–0303, hurstj@ nhlbi.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: November 1, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–24144 Filed 11–6–17; 8:45 am] BILLING CODE 4140–01–P ethrower on DSK3G9T082PROD with NOTICES III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the [FR Doc. 2017–24195 Filed 11–6–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:29 Nov 06, 2017 Jkt 244001 National Institutes of Health Center for Scientific Review; Notice of Closed Meetings PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 51637 provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Synthetic Psychoactive Drugs and Strategic Approaches to Counteract their Deleterious Effects. Date: November 30, 2017. Time: 1:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jasenka Borzan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892–7814, 301– 435–1787, borzanj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neuroimmunology, Neuroinflammation and Brain Tumor. Date: December 6, 2017. Time: 10:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Nataliya Gordiyenko, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5202, MSC 7846, Bethesda, MD 20892, 301–435– 1265, gordiyenkon@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Retinal Synapses and Circuitry. Date: December 6, 2017. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Afia Sultana, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 4189, Bethesda, MD 20892, (301) 827–7083, sultanaa@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) E:\FR\FM\07NON1.SGM 07NON1 51638 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices Dated: November 1, 2017. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–24143 Filed 11–6–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–6045–N–01] Annual Indexing of Basic Statutory Mortgage Limits for Multifamily Housing Programs Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD. ACTION: Notice. AGENCY: In accordance with Section 206A of the National Housing Act, HUD has adjusted the Basic Statutory Mortgage Limits for Multifamily Housing Programs for Calendar Year 2017. SUMMARY: DATES: January 1, 2017. FOR FURTHER INFORMATION CONTACT: ethrower on DSK3G9T082PROD with NOTICES Daniel J. Sullivan, Deputy Director, Office of Multifamily Development, Department of Housing and Urban Development, 451 Seventh Street SW., Washington, DC 20410–8000, telephone (202) 402–6130 (this is not a toll-free number). Hearing or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Information Relay Service at (800) 877–8339. SUPPLEMENTARY INFORMATION: The FHA Down Payment Simplification Act of 2002 (Pub. L. 107–326, approved December 4, 2002) amended the National Housing Act by adding a new Section 206A (12 U.S.C. 1712a). Under Section 206A, the following are affected: I. Section 207(c)(3)(A) (12 U.S.C. 1713(c)(3)(A)); II. Section 213(b)(2)(A) (12 U.S.C. 1715e(b)(2)(A)); III. Section 220(d)(3)(B)(iii)(I) (12 U.S.C. 1715k(d)(3)(B)(iii)(I)); IV. Section 221(d)(4)(ii)(I) (12 U.S.C. 1715l(d)(4)(ii)(I)); V. Section 231(c)(2)(A) (12 U.S.C. 1715v(c)(2)(A)); and VI. Section 234(e)(3)(A) (12 U.S.C. 1715y(e)(3)(A)). The Dollar Amounts in these sections are the base per unit statutory limits for FHA’s multifamily mortgage programs collectively referred to as the ‘Dollar Amounts.’ They are adjusted annually (commencing in 2004) on the effective date of the Consumer Financial Protection Bureau’s adjustment of the VerDate Sep<11>2014 17:29 Nov 06, 2017 Jkt 244001 $400 figure in the Home Ownership and Equity Protection Act of 1994 (HOEPA) (Pub. L. 103–325, approved September 23, 1994). The adjustment of the Dollar Amounts shall be calculated using the percentage change in the Consumer Price Index for All Urban Consumers (CPI–U) as applied by the Bureau of Consumer Financial Protection for purposes of the above-described HOEPA adjustment. HUD has been notified of the percentage change in the CPI–U used for the HOEPA adjustment and the effective date of the HOEPA adjustment. The percentage change in the CPI–U is 2.1 percent and the effective date of the HOEPA adjustment is January 1, 2017. The Dollar Amounts have been adjusted correspondingly and have an effective date of January 1, 2017. These revised statutory limits, high cost areas and per unit cost thresholds for substantial rehabilitation may be applied to FHA multifamily mortgage insurance applications submitted or amended on or after July 1, 2017, so long as the loan has not been initially endorsed. The adjusted Dollar Amounts for Calendar Year 2017 are shown below: Basic Statutory Mortgage Limits for Calendar Year 2017 Multifamily Loan Program Section 207—Multifamily Housing Section 207 pursuant to Section 223(f)— Purchase or Refinance Housing Section 220—Housing in Urban Renewal Areas Bedrooms 0 ................ 1 ................ 2 ................ 3 ................ 4+ .............. Non-elevator $51,575 57,133 68,244 84,116 95,228 0 ................ 1 ................ 2 ................ 3 ................ 4+ .............. Non-elevator $55,894 64,447 77,725 99,489 110,837 Bedrooms 0 ................ 1 ................ 2 ................ 3 ................ 4+ .............. Non-elevator $51,328 58,266 70,429 88,400 99,890 Elevator $55,445 63,562 77,291 99,988 109,758 Section 231—Housing for the Elderly Bedrooms 0 ................ 1 ................ 2 ................ 3 ................ 4+ .............. Non-elevator $48,800 54,555 65,147 78,401 92,173 Elevator $55,445 63,562 77,291 99,988 109,758 Section 207—Manufactured Home Parks Per Space—$23,678 Per Unit Limit for Substantial Rehabilitation for Calendar Year 2017 The 2016 Multifamily Accelerated Processing (MAP) Guide established a base amount of $15,000 per unit to define substantial rehabilitation for FHA insured loan programs. Section 5.1.D.2 of the MAP guide requires that this base amount be adjusted periodically based on the percentage change published by the Consumer Financial Protection Bureau or other inflation cost index published by HUD. Accordingly, the 2017 base amount per dwelling unit to determine substantial rehabilitation for FHA insured loan programs is $15,315. Environmental Impact Elevator $60,158 66,657 81,734 102,368 115,749 Section 213—Cooperatives Bedrooms Section 221(d)(4)—Moderate Income Housing Elevator $59,515 67,428 81,993 106,073 116,438 This issuance establishes mortgage and cost limits that do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321). Dated: October 31, 2017. Dana T. Wade, General Deputy Assistant Secretary for Housing. [FR Doc. 2017–24171 Filed 11–6–17; 8:45 am] Section 234—Condominium Housing Bedrooms 0 ................ 1 ................ 2 ................ 3 ................ 4+ .............. PO 00000 Frm 00042 Non-elevator $57,035 65,762 79,311 101,521 113,098 Fmt 4703 Sfmt 9990 BILLING CODE 4210–67–P Elevator $60,021 68,806 83,667 108,239 118,812 E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51637-51638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24143]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meetings.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR Panel: Synthetic Psychoactive Drugs and Strategic 
Approaches to Counteract their Deleterious Effects.
    Date: November 30, 2017.
    Time: 1:00 p.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Jasenka Borzan, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 
20892-7814, 301-435-1787, borzanj@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Neuroimmunology, Neuroinflammation and Brain 
Tumor.
    Date: December 6, 2017.
    Time: 10:00 a.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Nataliya Gordiyenko, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5202, MSC 7846, Bethesda, MD 
20892, 301-435-1265, gordiyenkon@csr.nih.gov.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Retinal Synapses and Circuitry.
    Date: December 6, 2017.
    Time: 12:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Afia Sultana, Ph.D., Scientific Review Officer, 
National Institutes of Health, Center for Scientific Review, 6701 
Rockledge Drive, Room 4189, Bethesda, MD 20892, (301) 827-7083, 
sultanaa@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)


[[Page 51638]]


    Dated: November 1, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-24143 Filed 11-6-17; 8:45 am]
BILLING CODE 4140-01-P
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