National Center for Advancing Translational Sciences; Notice of Closed Meeting, 57284 [2017-25982]

Download as PDF 57284 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Guidance recommendations Number of responses per respondent Total annual responses Average burden per response Total hours New written requests to be placed on the lists ................... Third-party certification ........................................................ Biennial update .................................................................... Third-party certification biennial update ............................... Occasional updates ............................................................. 370 370 555 555 100 1 1 1 1 1 370 370 555 555 100 1 21 1 21 0.5 370 7,770 555 11,655 50 Total .............................................................................. ........................ ........................ ........................ ........................ 20,400 sradovich on DSK3GMQ082PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This is a newly established information collection. Based on our experience maintaining other export lists, we estimate that, annually, an average of 370 new manufacturers/ processors will submit written requests to be placed on the China lists. The estimate of the number of hours that it will take a manufacturer/processor to gather the information needed to be placed on a list or update its information is based on FDA’s experience with manufacturers/ processors submitting similar requests. FDA believes that the information to be submitted will be readily available to manufacturers/processors. We estimate that a firm will require 1 hour to read the guidance, to gather the information needed, and to prepare a communication to FDA that contains the information needed to request that the manufacturer/processor be placed on a list. To be placed on a list, manufacturers/ processors should provide FDA with evidence that they have obtained thirdparty certification from a CNCAacknowledged certifier that the manufacturer/processor complies with the standards, laws and regulations of China according to relevant requirements specified in AQSIQ Decree 145. Based on our experience with other certification programs, FDA estimates that it will take each new manufacturer/ processor about 21 hours to complete the third-party certification process for a total of 7,770 burden hours (370 manufacturers/processors × 21 hours). Under the guidance, every 2 years each manufacturer/processor on the lists must provide updated information to remain on the lists. FDA estimates that each year approximately half of the manufacturers/processors on the lists, or 555 manufacturers/processors (1110 manufacturers/processors × 0.5 = 555), will resubmit the information to remain on the lists. We estimate that a manufacturer/processor already on the lists will require 1 hour to biennially update and resubmit the information to VerDate Sep<11>2014 18:22 Dec 01, 2017 Jkt 244001 FDA, including time reviewing the information and corresponding with FDA, for a total of 555 hours. During the biennial update, manufacturers/processors also need to be recertified by a third-party certifier to remain on the lists. FDA estimates that each year approximately half of the manufacturers/processors on the lists, 555 manufacturers/processors (1110 manufacturers/processors × 0.5 = 555), will get recertified. We estimate that it will take each manufacturer/processor about 21 hours to complete the certification process for a total of 11,655 burden hours (555 manufacturers/ processors × 21 hours). FDA expects that, each year, approximately 100 manufacturers/ processors will need to submit an occasional update and each manufacturer/processor will require 0.5 hours to prepare a communication to FDA reporting the change, for a total of 50 hours. Dated: November 29, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26042 Filed 12–1–17; 8:45 am] BILLING CODE 4164–01–P individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; CTSA. Date: February 21, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, Independence Ballrooms 1 & 2, 6711 Democracy Blvd., Bethesda, MD 20817. Contact Person: Carol Lambert, Ph.D., Acting Director, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1076, Bethesda, MD 20892, 301–435– 0814, lambert@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: November 28, 2017. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–25982 Filed 12–1–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; 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 PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; 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 E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Page 57284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25982]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Center for Advancing Translational Sciences; 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 Center for Advancing Translational 
Sciences Special Emphasis Panel; CTSA.
    Date: February 21, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Bethesda Marriott Suites, Independence Ballrooms 1 & 2, 
6711 Democracy Blvd., Bethesda, MD 20817.
    Contact Person: Carol Lambert, Ph.D., Acting Director, Office of 
Scientific Review, National Center for Advancing Translational 
Sciences (NCATS), National Institutes of Health, 6701 Democracy 
Blvd., Democracy 1, Room 1076, Bethesda, MD 20892, 301-435-0814, 
lambert@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.859, 
Pharmacology, Physiology, and Biological Chemistry Research; 93.350, 
B--Cooperative Agreements; 93.859, Biomedical Research and Research 
Training, National Institutes of Health, HHS)

    Dated: November 28, 2017.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-25982 Filed 12-1-17; 8:45 am]
BILLING CODE 4140-01-P