81_FR_61857 81 FR 61684 - Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)

81 FR 61684 - Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 173 (September 7, 2016)

Page Range61684-61685
FR Document2016-21400

Federal Register, Volume 81 Issue 173 (Wednesday, September 7, 2016) 
[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61684-61685]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Board of Scientific Counselors, Office of Infectious Diseases 
(BSC, OID)

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC), announces the following meeting of the aforementioned 
committee:
    Times and Dates: 8:30 a.m.-5:00 p.m., EDT, September 27, 2016; 8:00 
a.m.-12:00 p.m., EDT, September 28, 2016.
    Place: CDC, Global Communications Center, 1600 Clifton Road NE., 
Building 19, Auditorium B3, Atlanta, Georgia 30333.
    Status: The meeting is open to the public, limited only by the 
space available.
    Purpose: The BSC, OID, provides advice and guidance to the 
Secretary, Department of Health and Human Services; the Director, CDC; 
the Director, OID; and the Directors of the National Center for 
Immunization and Respiratory Diseases, the National Center for Emerging 
and Zoonotic Infectious Diseases, and the National Center for HIV/AIDS, 
Viral Hepatitis, STD, and TB Prevention, CDC, in the following areas: 
strategies, goals, and priorities for programs; research within the 
national centers; and overall strategic direction and focus of OID and 
the national centers.
    Matters for Discussion: The meeting will include updates from CDC's 
infectious disease national centers; a report from the Board's Food 
Safety Modernization Act Surveillance Working Group; and focused 
discussions on several program priorities, including viral hepatitis, 
Zika, and antimicrobial resistance.
    Agenda items are subject to change as priorities dictate.
    Contact Person for More Information: Robin Moseley, M.A.T., 
Designated Federal Officer, OID, CDC, 1600 Clifton Road NE., Mailstop 
D10, Atlanta, Georgia 30333, Telephone: (404) 639-4461.
    The Director, Management Analysis and Services Office has been 
delegated the authority to sign Federal Register notices pertaining to 
announcements of meetings and other committee management activities, 
for both the Centers for Disease Control and Prevention and the Agency 
for Toxic Substances and Disease Registry.

[[Page 61685]]


Elaine L. Baker, MPH, DLP,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 2016-21400 Filed 9-6-16; 8:45 am]
 BILLING CODE 4163-18-P

61684 Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices DEPARTMENT OF HEALTH AND relating to occupational safety and DEPARTMENT OF HEALTH AND HUMAN SERVICES health and to mine health. The Board of HUMAN SERVICES Scientific Counselors provides guidance Centers for Disease Control and to the Director, National Institute for Centers for Disease Control and Prevention Occupational Safety and Health on Prevention research and prevention programs. Board of Scientific Counselors, Board of Scientific Counselors, Office Specifically, the Board provides National Institute for Occupational of Infectious Diseases (BSC, OID) Safety and Health (BSC, NIOSH) guidance on the Institute’s research activities related to developing and In accordance with section 10(a)(2) of In accordance with section 10(a)(2) of evaluating hypotheses, systematically the Federal Advisory Committee Act the Federal Advisory Committee Act documenting findings and (Pub. L. 92–463), the Centers for Disease (Pub. L. 92–463), the Centers for Disease disseminating results. The Board Control and Prevention (CDC), Control and Prevention (CDC) evaluates the degree to which the announces the following meeting of the announces the following meeting for the activities of the National Institute for aforementioned committee: aforementioned committee: Occupational Safety and Health: (1) Times and Dates: 8:30 a.m.–5:00 p.m., Time and Date: 8:30 a.m.–2:30 p.m., conform to appropriate scientific EDT, September 27, 2016; 8:00 a.m.– EDT, September 27, 2016. standards, (2) address current, relevant 12:00 p.m., EDT, September 28, 2016. Place: Patriots Plaza I, 395 E Street needs, and (3) produce intended results. SW., Room 9000, Washington, DC Place: CDC, Global Communications 20201. The meeting is also available via Matters for Discussion: NIOSH Center, 1600 Clifton Road NE., Building webcast. Director’s update; Chronic Kidney 19, Auditorium B3, Atlanta, Georgia Status: This meeting is open to the Disease and Pesticide Exposure; NIOSH 30333. public, limited only by the space Oil and Gas Sector Program; Status: The meeting is open to the available. The meeting room Engineering Controls for Additive (3D) public, limited only by the space accommodates approximately 33 Manufacturing, and Engineering available. people. The public is welcome to Controls and Nanomaterials. Purpose: The BSC, OID, provides participate during the public comment Agenda items are subject to change as advice and guidance to the Secretary, period, 12:30 p.m.–12:45 p.m. EDT, priorities dictate. Department of Health and Human September 27, 2016. Services; the Director, CDC; the Please note that the public comment An agenda is also posted on the Director, OID; and the Directors of the period ends at the time indicated above NIOSH Web site (http://www.cdc.gov/ National Center for Immunization and or following the last call for comments, niosh/bsc/). Members of the public who Respiratory Diseases, the National whichever is earlier. Members of the wish to address the NIOSH BSC are Center for Emerging and Zoonotic public who want to comment must sign requested to contact the Executive Infectious Diseases, and the National up by providing their name by mail, Secretary for scheduling purposes (see Center for HIV/AIDS, Viral Hepatitis, email, or telephone, at the addresses contact information below). STD, and TB Prevention, CDC, in the provided below by September 23, 2016. Alternatively, written comments to the following areas: strategies, goals, and Each commenter will be provided up to BSC may be submitted via an on-line priorities for programs; research within five minutes for comment. A limited form at the following Web site: http:// the national centers; and overall number of time slots are available and www.cdc.gov/niosh/bsc/contact.html. strategic direction and focus of OID and will be assigned on a first come-first Contact Person for More Information: the national centers. served basis. Written comments will Matters for Discussion: The meeting Paul J. Middendorf, Ph.D., Executive also be accepted from those unable to will include updates from CDC’s Secretary, BSC, NIOSH, CDC, 1600 attend the public session via an on-line infectious disease national centers; a form at the following Web site: http:// Clifton Road NE., MS–E20, Atlanta, GA 30329–4018, telephone (404) 498–2500, report from the Board’s Food Safety www.cdc.gov/niosh/bsc/contact.html. Modernization Act Surveillance The meeting is also open to the public fax (404) 498–2526. Working Group; and focused via webcast. If you wish to attend in The Director, Management Analysis discussions on several program person or by webcast, please see the and Services Office has been delegated priorities, including viral hepatitis, NIOSH Web site to register (http:// the authority to sign Federal Register Zika, and antimicrobial resistance. www.cdc.gov/niosh/bsc/) or call (404– notices pertaining to announcements of 498–2539) at least five business days in Agenda items are subject to change as meetings and other committee priorities dictate. advance of the meeting. Teleconference management activities, for both the is available toll-free; please dial (888) Centers for Disease Control and Contact Person for More Information: 397–9578, Participant Pass Code Robin Moseley, M.A.T., Designated Prevention and the Agency for Toxic 63257516. Adobe Connect webcast will Federal Officer, OID, CDC, 1600 Clifton Substances and Disease Registry. be available at https:// Road NE., Mailstop D10, Atlanta, odniosh.adobeconnect.com/nioshbsc/ Elaine L. Baker, MPH, DLP, Georgia 30333, Telephone: (404) 639– for participants wanting to connect Director, Management Analysis and Services 4461. remotely. Office, Centers for Disease Control and The Director, Management Analysis Purpose: The Secretary, the Assistant Prevention (CDC). and Services Office has been delegated mstockstill on DSK3G9T082PROD with NOTICES Secretary for Health, and by delegation [FR Doc. 2016–21399 Filed 9–6–16; 8:45 am] the authority to sign Federal Register the Director, Centers for Disease Control BILLING CODE 4163–19–P notices pertaining to announcements of and Prevention, are authorized under meetings and other committee Sections 301 and 308 of the Public management activities, for both the Health Service Act to conduct directly Centers for Disease Control and or by grants or contracts, research, Prevention and the Agency for Toxic experiments, and demonstrations Substances and Disease Registry. VerDate Sep<11>2014 18:44 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1

Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices 61685 Elaine L. Baker, MPH, DLP, comments be faxed to the Office of because the labeling (including Director, Management Analysis and Services Information and Regulatory Affairs, operating instructions) is included in Office, Centers for Disease Control and OMB, Attn: FDA Desk Officer, FAX: the premarket notification (510(k)) or Prevention (CDC). 202–395–7285, or emailed to oira_ premarket approval application (PMA). [FR Doc. 2016–21400 Filed 9–6–16; 8:45 am] submission@omb.eop.gov. All In some cases, however, a manufacturer BILLING CODE 4163–18–P comments should be identified with the may request Clinical Laboratory OMB control number 0910–0607. Also Improvement Amendments of 1998 include the FDA docket number found (CLIA) categorization even if FDA is not DEPARTMENT OF HEALTH AND in brackets in the heading of this simultaneously reviewing a 510(k) or HUMAN SERVICES document. PMA. One example is when a FOR FURTHER INFORMATION CONTACT: FDA manufacturer requests that FDA assign Food and Drug Administration CLIA categorization to a previously PRA Staff, Office of Operations, Food [Docket No. FDA–2013–N–0514] and Drug Administration, Three White cleared device that has changed names Flint North 10A–12M, 11601 since the original CLIA categorization. Agency Information Collection Another example is when a device is Landsdown St., North Bethesda, MD Activities; Submission for Office of exempt from premarket review. In such 20852, PRAStaff@fda.hhs.gov. Management and Budget Review; cases, the guidance recommends that Comment Request; Requests for SUPPLEMENTARY INFORMATION: In manufacturers provide FDA with a copy Clinical Laboratory Improvement compliance with 44 U.S.C. 3507, FDA of the package insert for the device and Amendments Categorization has submitted the following proposed a cover letter indicating why the collection of information to OMB for manufacturer is requesting a AGENCY: Food and Drug Administration, review and clearance. HHS. categorization (e.g. name change, Requests for Clinical Laboratory exempt from 510(k) review). The ACTION: Notice. guidance recommends that in the Improvement Amendments of 1988 SUMMARY: The Food and Drug Categorization—42 CFR 493.17—OMB correspondence to FDA the Administration (FDA) is announcing Control Number 0910–0607—Extension manufacturer should identify the that a proposed collection of product code and classification as well A guidance document entitled information has been submitted to the as reference to the original 510(k) when ‘‘Guidance for Administrative Office of Management and Budget this is available. Procedures for CLIA Categorization’’ (OMB) for review and clearance under was released on May 7, 2008. The In the Federal Register of April 27, the Paperwork Reduction Act of 1995. document describes procedures FDA 2016 (81 FR 24820), FDA published a DATES: Fax written comments on the uses to assign the complexity category 60-day notice requesting public collection of information by October 7, to a device. Typically, FDA assigns comment on the proposed collection of 2016. complexity categorizations to devices at information. No comments were ADDRESSES: To ensure that comments on the time of clearance or approval of the received. the information collection are received, device. In this way, no additional FDA estimates the burden of this OMB recommends that written burden is incurred by the manufacturer collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1 Total operating Number of Average Number of Total annual and Activity responses per burden per Total hours respondents responses maintenance respondent response costs Request for CLIA Categorization ............. 60 15 900 1 900 $46,800 1 There are no capital costs associated with this collection of information. The number of respondents is Dated: August 31, 2016. DEPARTMENT OF HEALTH AND approximately 60. On average, each Leslie Kux, HUMAN SERVICES respondent will request categorizations Associate Commissioner for Policy. (independent of a 510(k) or PMA) 15 Food and Drug Administration [FR Doc. 2016–21352 Filed 9–6–16; 8:45 am] times per year. The cost, not including BILLING CODE 4164–01–P personnel, is estimated at $52 per hour [Docket No. FDA–2013–N–0731] (52 × 900), totaling $46,800. This includes the cost of copying and mailing Agency Information Collection copies of package inserts and a cover Activities; Proposed Collection; letter, which includes a statement of the Comment Request; Human Cells, Tissues, and Cellular and Tissue- reason for the request and reference to Based Products: Establishment the original 510(k) numbers, including mstockstill on DSK3G9T082PROD with NOTICES Registration and Listing; Eligibility regulation numbers and product codes. Determination for Donors; and Current The burden hours are based on FDA Good Tissue Practice familiarity with the types of documentation typically included in a AGENCY: Food and Drug Administration, sponsor’s categorization requests, and HHS. costs for basic office supplies (e.g., ACTION: Notice. paper). VerDate Sep<11>2014 18:44 Sep 06, 2016 Jkt 238001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1


Document Created: 2016-09-07 11:50:44
Document Modified: 2016-09-07 11:50:44
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
Dates8:30 a.m.-5:00 p.m., EDT, September 27, 2016; 8:00 a.m.-12:00 p.m., EDT, September 28, 2016.
FR Citation81 FR 61684 
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