National Institute on Aging; Notice of Closed Meeting, 2747 [2020-00577]

Download as PDF Federal Register / Vol. 85, No. 11 / Thursday, January 16, 2020 / Notices New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993–0002 or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Gregory Reaman, Oncology Center of Excellence, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2202, Silver Spring, MD 20993–0002, 301–796–0785; 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INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Pediatric Study Plans for Oncology Drugs: Questions and Answers.’’ This draft guidance provides information regarding the submission of an iPSP, as required by section 505B(e) of the FD&C Act (21 U.S.C. 355c(e)), for oncology drugs only. When finalized, this draft guidance will provide FDA’s current thinking regarding iPSPs for oncology drugs in light of the amendments to section 505B of the FD&C Act (also referred to as the Pediatric Research Equity Act, or PREA) made by section 504 of FDARA (Pub. L. 115–52). This draft guidance does not contain a complete discussion of general requirements for development of drugs for pediatric use under PREA or section 505A of the FD&C Act (21 U.S.C. 355a) (also referred to as the Best Pharmaceuticals for Children Act or BPCA (Pub. L. 107–109)). Section 504 of FDARA amended section 505B of the FD&C Act to require—for original applications submitted on or after August 18, 2020— pediatric investigations of certain targeted cancer drugs with new active ingredients, based on molecular mechanism of action rather than clinical indication. FDARA thus created a mechanism to require evaluation of certain novel medicines that may have the potential to address an unmet VerDate Sep<11>2014 17:49 Jan 15, 2020 Jkt 250001 medical need in the pediatric population. Timely investigation in children of the antitumor activity of potentially effective targeted drugs under development in adults and of those drugs’ toxicities relative to the unique growth and developmental considerations of pediatric patients, is intended to accelerate early pediatric evaluation of these products and ultimately facilitate development of appropriate new therapies for pediatric patients. 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 ‘‘Pediatric Study Plans for Oncology Drugs: Questions and Answers.’’ 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. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014. The collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm, or https://www.regulations.gov. Dated: January 10, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–00592 Filed 1–15–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 2747 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following 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: National Institute on Aging Special Emphasis Panel; Early Diagnosis and Prediction. Date: February 13, 2020. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Nijaguna Prasad, Ph.D., Scientific Review Officer, Scientific Review Branch, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Gateway Building, Suite 2W200, Bethesda, MD 20892, (301) 496–9667, nijaguna.prasad@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: January 10, 2020. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–00577 Filed 1–15–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Privacy Act of 1974; System of Records Notice National Institutes of Health (NIH), Department of Health and Human Services (HHS). ACTION: Notice of a modified system of records and rescindment of a system of records notice. AGENCY: In accordance with the requirements of the Privacy Act of 1974, SUMMARY: Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\16JAN1.SGM 16JAN1

Agencies

[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Notices]
[Page 2747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following 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: National Institute on Aging Special Emphasis 
Panel; Early Diagnosis and Prediction.
    Date: February 13, 2020.
    Time: 1:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institute on Aging, Gateway Building, 7201 
Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Nijaguna Prasad, Ph.D., Scientific Review 
Officer, Scientific Review Branch, National Institute on Aging, 
National Institutes of Health, 7201 Wisconsin Avenue, Gateway 
Building, Suite 2W200, Bethesda, MD 20892, (301) 496-9667, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging 
Research, National Institutes of Health, HHS)

    Dated: January 10, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-00577 Filed 1-15-20; 8:45 am]
 BILLING CODE 4140-01-P