82_FR_60266 82 FR 60025 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings

82 FR 60025 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 241 (December 18, 2017)

Page Range60025-60026
FR Document2017-27129

Federal Register, Volume 82 Issue 241 (Monday, December 18, 2017) 
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60025-60026]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health & Human 
Development; 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

[[Page 60026]]

applications, the disclosure of which would constitute a clearly 
unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human 
Development Initial Review Group; Population Sciences Subcommittee.
    Date: February 9, 2017.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Minki Chatterji, Scientific Review Officer, 
Scientific Review Branch, Eunice Kennedy Shriver National Institute 
of Child Health and Human Development, NIH, DHHS, 6710B Rockledge 
Drive, Rm. 2121D, Bethesda, MD 20892-7501, 301-827-5435, 
[email protected].

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel; Archiving and Documenting Child 
Health and Human Development Data Sets.
    Date: February 9, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, 
MD 20814.
    Contact Person: Minki Chatterji, Scientific Review Officer, 
Scientific Review Branch, Eunice Kennedy Shriver National Institute 
of Child Health and Human Development, NIH, DHHS, 6710B Rockledge 
Drive, Rm. 2121D, Bethesda, MD 20892-7501, 301-827-5435, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research; 93.865, Research for Mothers and Children; 
93.929, Center for Medical Rehabilitation Research; 93.209, 
Contraception and Infertility Loan Repayment Program, National 
Institutes of Health, HHS)

    Dated: December 12, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-27129 Filed 12-15-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60025 SUPPLEMENTARY INFORMATION: Center for Devices and Radiological amended, notice is hereby given of the Health guidance documents is available following meeting. I. Background The meeting will be closed to the at https://www.fda.gov/MedicalDevices/ In 2003, FDA issued updated DeviceRegulationandGuidance/ public in accordance with the guidance on the ‘‘replacement reagent GuidanceDocuments/default.htm. This provisions set forth in sections and instrument family policy’’ for in guidance document is also available at 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., vitro diagnostic (IVD) devices. The 2003 https://www.regulations.gov. Persons as amended. The grant applications and guidance described a mechanism for unable to download an electronic copy the discussions could disclose manufacturers to follow when applying of ‘‘Replacement Reagent and confidential trade secrets or commercial an assay that was previously cleared for Instrument Family Policy for In Vitro property such as patentable material, use based on performance Diagnostic Devices’’ may send an email and personal information concerning characteristics with a specified request to CDRH-Guidance@fda.hhs.gov individuals associated with the grant instrument, to an additional instrument to receive an electronic copy of the applications, the disclosure of which that was previously cleared or that is a document. Please use the document would constitute a clearly unwarranted member of an instrument family from number 16045 to identify the guidance invasion of personal privacy. which another member has been you are requesting. Name of Committee: National Institute of previously cleared. Through the Allergy and Infectious Diseases Special approach described in the 2003 IV. Paperwork Reduction Act of 1995 Emphasis Panel; NIAID Clinical Trial guidance, manufacturers established This draft guidance refers to Planning Grant (R34) and Implementation sufficient control to maintain the level previously approved collections of Cooperative Agreement (U01). of safety and effectiveness demonstrated Date: January 16, 2018. information found in FDA regulations Time: 10:00 a.m. to 12:00 p.m. in the cleared device for these types of and guidances. These collections of modified devices, when evaluated Agenda: To review and evaluate grant information are subject to review by the applications. against predefined acceptance criteria Office of Management and Budget Place: National Institutes of Health, 5601 using a proper validation protocol, (OMB) under the Paperwork Reduction Fishers Lane, Rockville, MD 20892 without submission of a premarket Act of 1995 (44 U.S.C. 3501–3520). The (Telephone Conference Call). notification (510(k)). collections of information in 21 CFR Contact Person: Maryam Feili-Hariri, FDA believes this policy is important Ph.D., Scientific Review Officer, Scientific part 820 are approved under OMB Review Program, Division of Extramural for public health as it promotes more control number 0910–0073; the Activities, National Institutes of Health/ timely availability of a wider array of collections of information in 21 CFR NIAID, 5601 Fishers Lane, Rockville, MD clinical laboratory tests for patient part 807, subpart E are approved under 20852, 240–669–5026, haririmf@ benefit. To ensure that its full benefits OMB control number 0910–0120; the niaid.nih.gov. are realized, FDA is providing collections of information in 21 CFR (Catalogue of Federal Domestic Assistance additional clarity to help manufacturers parts 801 and 809 are approved under Program Nos. 93.855, Allergy, Immunology, and FDA better apply the concepts in and Transplantation Research; 93.856, OMB control number 0910–0485; the the guidance. Microbiology and Infectious Diseases This draft guidance, when finalized, collections of information in the guidance document ‘‘Administrative Research, National Institutes of Health, HHS) is intended to update and provide Procedures for CLIA [Clinical Dated: December 12, 2017. clarity on the Replacement Reagent and Instrument Family Policy for Laboratory Improvement Amendments Natasha M. Copeland, manufacturers of IVD devices and FDA of 1988] Categorization’’ are approved Program Analyst, Office of Federal Advisory staff. It incorporates concepts and under OMB control number 0910–0607; Committee Policy. recommendations from FDA’s guidance and the collections of information for [FR Doc. 2017–27128 Filed 12–15–17; 8:45 am] entitled ‘‘Deciding When to Submit a requests for feedback on medical device BILLING CODE 4140–01–P 510(k) for a Change to an Existing submissions in the guidance document Device,’’ issued on October 25, 2017 (82 ‘‘Requests for Feedback on Medical FR 49375). Device Submissions: The Pre- DEPARTMENT OF HEALTH AND Submission Program and Meetings with HUMAN SERVICES II. Significance of Guidance Food and Drug Administration Staff’’ This draft guidance is being issued are approved under OMB control National Institutes of Health consistent with FDA’s good guidance number 0910–0756. Eunice Kennedy Shriver National practices regulation (21 CFR 10.115). Dated: December 12, 2017. Institute of Child Health & Human The draft guidance, when finalized, will Leslie Kux, Development; Notice of Closed represent the current thinking of FDA Associate Commissioner for Policy. Meetings on the Replacement Reagent and [FR Doc. 2017–27132 Filed 12–15–17; 8:45 am] Instrument Family Policy for In Vitro Pursuant to section 10(d) of the BILLING CODE 4164–01–P Diagnostic Devices. It does not establish Federal Advisory Committee Act, as any rights for any person and is not amended, notice is hereby given of the binding on FDA or the public. You can DEPARTMENT OF HEALTH AND following meetings. use an alternative approach if it satisfies The meetings will be closed to the HUMAN SERVICES the requirements of the applicable public in accordance with the statutes and regulations. This guidance National Institutes of Health provisions set forth in sections daltland on DSKBBV9HB2PROD with NOTICES is not subject to Executive Order 12866. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Institute of Allergy and as amended. The grant applications and III. Electronic Access Infectious Diseases; Notice of Closed the discussions could disclose Persons interested in obtaining a copy Meeting confidential trade secrets or commercial of the draft guidance may do so by property such as patentable material, downloading an electronic copy from Pursuant to section 10(d) of the and personal information concerning the internet. A search capability for all Federal Advisory Committee Act, as individuals associated with the grant VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1

60026 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices applications, the disclosure of which following information collection request businesses, sectors of critical would constitute a clearly unwarranted (ICR) to the Office of Management and infrastructure, and information sharing invasion of personal privacy. Budget (OMB) for review and clearance organizations. This provision includes Name of Committee: National Institute of in accordance with the Paperwork the authority to receive, analyze and Child Health and Human Development Initial Reduction Act of 1995. DHS previously disseminate information about Review Group; Population Sciences published this ICR in the Federal cybersecurity risks and incidents and to Subcommittee. Register on Tuesday, July 18, 2017 at 82 provide guidance, assessments, incident Date: February 9, 2017. FR 32859 for a 60-day public comment response support, and other technical Time: 8:00 a.m. to 5:00 p.m. period. Ten comments from two assistance upon request and codifies Agenda: To review and evaluate grant commenters were received by DHS. The NPPD’s coordinating role among Federal applications. purpose of this notice is to allow an Place: Residence Inn Bethesda, 7335 and non-Federal entities. 6 U.S.C. 148. Wisconsin Avenue, Bethesda, MD 20814. additional 30 days for public comments. As part of its information sharing Contact Person: Minki Chatterji, Scientific DATES: Comments are encouraged and responsibilities with non-Federal Review Officer, Scientific Review Branch, will be accepted until January 17, 2018. entities, the National Defense Eunice Kennedy Shriver National Institute of This process is conducted in accordance Authorization Act For Fiscal Year 2017 Child Health and Human Development, NIH, with 5 CFR part 1320. (NDAA) amended the Homeland DHHS, 6710B Rockledge Drive, Rm. 2121D, ADDRESSES: Interested persons are Security Act to authorize the Bethesda, MD 20892–7501, 301–827–5435, minki.chatterji@nih.gov. invited to submit written comments on Department to specifically focus on the proposed information collection to small businesses. See Public Law 114– Name of Committee: National Institute of Child Health and Human Development the Office of Information and Regulatory 328 (2016). Specifically, the NDAA Special Emphasis Panel; Archiving and Affairs, OMB. You may send comments, authorizes NPPD, through the Secretary, Documenting Child Health and Human identified by the words ‘‘Department of to ‘‘leverage small business Development Data Sets. Homeland Security’’ and ‘‘OMB Control development centers to provide Date: February 9, 2018. Number 1670—NEW (IT Sector assistance to small business concerns by Time: 8:00 a.m. to 5:00 p.m. Survey)’’, by: disseminating information on cyber Agenda: To review and evaluate grant Æ Email: dhsdeskofficer@ threat indicators, defense measures, applications. omb.eop.gov. Include ‘‘Department of cybersecurity risks, incidents, analyses, Place: Residence Inn Bethesda, 7335 Homeland Security’’ and ‘‘OMB Control and warnings to help small business Wisconsin Avenue, Bethesda, MD 20814. Number 1670—NEW (IT Sector concerns in developing or enhancing Contact Person: Minki Chatterji, Scientific Review Officer, Scientific Review Branch, Survey)’’ in the subject line of the cybersecurity infrastructure, awareness Eunice Kennedy Shriver National Institute of message. of cyber threat indicators, and cyber Child Health and Human Development, NIH, Instructions: Comments submitted in training programs for employees.’’ See 6 DHHS, 6710B Rockledge Drive, Rm. 2121D, response to this notice may be made U.S.C. 148(l)(1); see also 15 U.S.C. Bethesda, MD 20892–7501, 301–827–5435, available to the public through relevant 648(a)(8)(A) (similarly authorizing DHS minki.chatterji@nih.gov. websites. For this reason, please do not ‘‘and any other Federal department or (Catalogue of Federal Domestic Assistance include in your comments information agency in coordination with the Program Nos. 93.864, Population Research; of a confidential nature, such as Department of Homeland Security’’ to 93.865, Research for Mothers and Children; sensitive personal information or ‘‘leverage small business concerns by 93.929, Center for Medical Rehabilitation proprietary information. If you send an disseminating information relating to Research; 93.209, Contraception and email comment, your email address will Infertility Loan Repayment Program, National cybersecurity risks and other homeland be automatically captured and included security matters to help small business Institutes of Health, HHS) as part of the comment that is placed in concerns in developing or enhancing Dated: December 12, 2017. the public docket and made available on cybersecurity infrastructure, awareness Michelle Trout, the internet. Please note that responses of cyber threat indicators, and cyber Program Analyst, Office of Federal Advisory to this public comment request training programs for employees’’). Committee Policy. containing any routine notice about the Consistent with these authorities, E.O. [FR Doc. 2017–27129 Filed 12–15–17; 8:45 am] confidentiality of the communication 13636 directs the Department to BILLING CODE 4140–01–P will be treated as public comments that increase its cybersecurity information may be made available to the public sharing efforts with the private sector notwithstanding the inclusion of the and consult on and promote the DEPARTMENT OF HOMELAND routine notice. National Institute of Standards and SECURITY FOR FURTHER INFORMATION CONTACT: For Technology (NIST) Cybersecurity specific questions related to collection Framework. To facilitate the The Department of Homeland Security, activities, please contact Reggie Department’s promotion of the NIST Stakeholder Engagement & Cyber McKinney at 703–705–6277 or at Cybersecurity Framework, the E.O. Infrastructure Resilience Division reggie.mckinney@hq.dhs.gov. directs the Secretary to establish a (SECIR) SUPPLEMENTARY INFORMATION: Section voluntary program to support the AGENCY: National Protection and 227 of the Homeland Security Act of adoption of the Framework in Programs Directorate (NPPD), 2002 authorizes the National coordination with Sector Specific Department of Homeland Security Cybersecurity and Communications Agencies, which in turn ‘‘shall (DHS). Integration Center (NCCIC) within NPPD coordinate with Sector Coordinating daltland on DSKBBV9HB2PROD with NOTICES ACTION: 30-Day notice and request for as a ‘‘Federal civilian interface for the Councils to review the Cybersecurity comments; new information collection multi-directional and cross-sector Framework and, if necessary, develop request: 1670—NEW. sharing of information related to . . . implementation guidance or cybersecurity risks.’’ 6 U.S.C. 148(c)(1). supplemental materials to address SUMMARY: The DHS NPPD Office of This authority applies to Federal and sector-specific risks and operating Cybersecurity and Communications non-Federal entities, including the environments.’’ E.O. 13636, 78 FR (CS&C), SECIR, will submit the private sector, small and medium 11739 (2013). VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1


Document Created: 2017-12-15 23:54:39
Document Modified: 2017-12-15 23:54:39
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
DatesFebruary 9, 2017.
FR Citation82 FR 60025 
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