82_FR_60257 82 FR 60016 - Notice of Closed Meeting

82 FR 60016 - Notice of Closed Meeting

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

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

Page Range60016-60017
FR Document2017-27165

Federal Register, Volume 82 Issue 241 (Monday, December 18, 2017) 
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60016-60017]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-27165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Notice of Closed Meeting

    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.
    The meeting will be closed to the public in accordance with 
provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., 
and the Determination of the Director, Management Analysis and Services 
Office, CDC, pursuant to Public Law 92-463.

    Name of Committee: Safety and Occupational Health Study Section 
(SOHSS), National Institute for Occupational Safety and Health 
(NIOSH).
    Date: February 6-7, 2018.
    Time: 8:00 a.m.-5:00 p.m., EST.
    Place: Embassy Suites, 1900 Diagonal Road, Alexandria, VA 22314.
    Agenda: The meeting will convene to address matters related to 
the conduct of

[[Page 60017]]

Study Section business and for the study section to consider safety 
and occupational health-related grant applications.
    For Further Information Contact: Nina Turner, Ph.D., Scientific 
Review Officer, NIOSH, 1095 Willowdale Road, Morgantown, WV 26506, 
(304) 285-5976; [email protected].

    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.

Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2017-27165 Filed 12-15-17; 8:45 am]
 BILLING CODE 4163-18-P

60016 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices Commission, Office of the Secretary, Paperwork Comment, FTC File No. confidentiality request that meets the Constitution Center, 400 7th Street SW, P114408’’ on your comment and on the requirements for such treatment under 5th Floor, Suite 5610 (Annex J), envelope, and mail it to the following FTC Rule 4.9(c), and the General Washington, DC 20024. address: Federal Trade Commission, Counsel grants that request. FOR FURTHER INFORMATION CONTACT: Office of the Secretary, 600 The FTC Act and other laws that the Requests for additional information Pennsylvania Avenue NW, Suite CC– Commission administers permit the should be addressed to Christine M. 5610 (Annex J), Washington, DC 20580, collection of public comments to Todaro, Attorney, Division of Marketing or deliver your comment to the consider and use in this proceeding as Practices, Bureau of Consumer following address: Federal Trade appropriate. The Commission will Protection, Federal Trade Commission, Commission, Office of the Secretary, consider all timely and responsive 600 Pennsylvania Avenue NW, Constitution Center, 400 7th Street SW, public comments that it receives on or CC–8528, Washington, DC 20580, (202) 5th Floor, Suite 5610 (Annex J), before January 17, 2018. For information 326–3711. Washington, DC 20024. If possible, on the Commission’s privacy policy, SUPPLEMENTARY INFORMATION: On submit your paper comment to the including routine uses permitted by the September 28, 2017, the FTC sought Commission by courier or overnight Privacy Act, see https://www.ftc.gov/ public comment on the information service. site-information/privacy-policy. collection requirements associated with Because your comment will be placed Comments on the information the Rule (September 28, 2017 Notice 1), on the publicly accessible FTC website collection requirements subject to 16 CFR part 437 (OMB Control Number at https://www.ftc.gov/, you are solely review under the PRA should 3084–0142). No relevant comments responsible for making sure that your additionally be submitted to OMB. If were received. Pursuant to the OMB comment does not include any sensitive sent by U.S. mail, they should be regulations, 5 CFR part 1320, that or confidential information. In addressed to Office of Information and implement the PRA, 44 U.S.C. 3501 et particular, your comment should not Regulatory Affairs, Office of seq., the FTC is providing this second include any sensitive personal Management and Budget, Attention: opportunity for public comment while information, such as your or anyone Desk Officer for the Federal Trade seeking OMB approval to renew the pre- else’s Social Security number; date of Commission, New Executive Office existing clearance for the Rule. birth; driver’s license number or other Building, Docket Library, Room 10102, state identification number, or foreign 725 17th Street NW, Washington, DC Burden Statement country equivalent; passport number; 20503. Comments sent to OMB by U.S. As detailed in the September 28, 2017 financial account number; or credit or postal mail are subject to delays due to Notice, the FTC estimates cumulative debit card number. You are also solely heightened security precautions. Thus, annual burden on affected entities to be responsible for making sure that your comments instead can also be sent via 10,065 hours, $2,516,250 in labor costs, comment does not include any sensitive email to wliberante@omb.eop.gov. and $3,062,224 in non-labor costs. health information, such as medical records or other individually David C. Shonka, Request for Comment identifiable health information. In Acting General Counsel. You can file a comment online or on addition, your comment should not [FR Doc. 2017–27207 Filed 12–15–17; 8:45 am] paper. For the FTC to consider your include any ‘‘trade secret or any BILLING CODE 6750–01–P comment, we must receive it on or commercial or financial information before January 17, 2018. Write which . . . is privileged or ‘‘Business Opportunity Rule Paperwork confidential’’—as provided by Section DEPARTMENT OF HEALTH AND Comment, FTC File No. P114408’’ on 6(f) of the FTC Act, 15 U.S.C. 46(f), and HUMAN SERVICES your comment. Your comment— FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— including your name and your state— including in particular competitively Centers for Disease Control and will be placed on the public record of sensitive information such as costs, Prevention this proceeding, including, to the extent sales statistics, inventories, formulas, practicable, on the public Commission patterns, devices, manufacturing Notice of Closed Meeting website, at http://www.ftc.gov/os/ processes, or customer names. In accordance with Section 10(a)(2) of publiccomments.shtm. Comments containing material for the Federal Advisory Committee Act Postal mail addressed to the which confidential treatment is (Pub. L. 92–463), the Centers for Disease Commission is subject to delay due to requested must be filed in paper form, Control and Prevention (CDC) heightened security screening. As a must be clearly labeled ‘‘Confidential,’’ announces the following meeting. result, we encourage you to submit your and must comply with FTC Rule 4.9(c). The meeting will be closed to the comments online, or to send them to the In particular, the written request for public in accordance with provisions set Commission by courier or overnight confidential treatment that accompanies forth in Section 552b(c) (4) and (6), Title service. To make sure that the the comment must include the factual 5 U.S.C., and the Determination of the Commission considers your online and legal basis for the request, and must Director, Management Analysis and comment, you must file it at https:// identify the specific portions of the Services Office, CDC, pursuant to Public ftcpublic.commentworks.com/ftc/ comment to be withheld from the public Law 92–463. tobaccoreportspra, by following the record. See FTC Rule 4.9(c). Your instructions on the web-based form. comment will be kept confidential only Name of Committee: Safety and When this Notice appears at http:// if the General Counsel grants your Occupational Health Study Section (SOHSS), daltland on DSKBBV9HB2PROD with NOTICES request in accordance with the law and National Institute for Occupational Safety www.regulations.gov/#!home, you also and Health (NIOSH). may file a comment through that the public interest. Once your comment Date: February 6–7, 2018. website. has been posted on the public FTC Time: 8:00 a.m.–5:00 p.m., EST. If you file your comment on paper, website—as legally required by FTC Place: Embassy Suites, 1900 Diagonal write ‘‘Business Opportunity Rule Rule 4.9(b)—we cannot redact or Road, Alexandria, VA 22314. remove your comment from the FTC Agenda: The meeting will convene to 1 82 FR 45288. website, unless you submit a address matters related to the conduct of VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1

Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices 60017 Study Section business and for the study meetings and other committee Respiratory Diseases, Centers for section to consider safety and occupational management activities, for both the Disease Control and Prevention, 1600 health-related grant applications. Centers for Disease Control and Clifton Road NE, Mail Stop D–11, For Further Information Contact: Nina Prevention and the Agency for Toxic Atlanta, GA 30329. Turner, Ph.D., Scientific Review Officer, NIOSH, 1095 Willowdale Road, Morgantown, Substances and Disease Registry. FOR FURTHER INFORMATION CONTACT: WV 26506, (304) 285–5976; nturner@cdc.gov. Elaine L. Baker, For Technical Questions: Lucia The Director, Management Analysis and Director, Management Analysis and Services Tondella, National Center for Services Office, has been delegated the Office, Centers for Disease Control and Immunization and Respiratory Diseases, authority to sign Federal Register notices Prevention. Centers for Disease Control and pertaining to announcements of meetings and [FR Doc. 2017–27164 Filed 12–15–17; 8:45 am] Prevention, 1600 Clifton Road NE, Mail other committee management activities, for BILLING CODE 4163–18–P Stop D–11, Atlanta, GA 30329. Phone: both the Centers for Disease Control and Prevention and the Agency for Toxic 404–639–1239, Email: PertussisDL@ Substances and Disease Registry. cdc.gov. DEPARTMENT OF HEALTH AND For Business Questions: Jason Elaine L. Baker, HUMAN SERVICES Cloward, Technology Transfer Office, Director, Management Analysis and Services Centers for Disease Control and Office, Centers for Disease Control and Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mail Prevention. Prevention Stop E–51, Atlanta, GA 30329. Phone: [FR Doc. 2017–27165 Filed 12–15–17; 8:45 am] Invitation to Manufacturers of 404–639–2679, Email: wnv3@cdc.gov. BILLING CODE 4163–18–P Pertussis Serological Kits SUPPLEMENTARY INFORMATION: CDC’s National Center for Immunization and AGENCY: Centers for Disease Control and DEPARTMENT OF HEALTH AND Respiratory Diseases (NCIRD), Division Prevention (CDC), Department of Health HUMAN SERVICES of Bacterial Diseases (DBD), Meningitis and Human Services (HHS). and Vaccine Preventable Diseases ACTION: Notice. Centers for Disease Control and Branch (MVPDB) has lead technical Prevention SUMMARY: The Centers for Disease responsibility for research, development Control and Prevention (CDC) within and evaluation of diagnostic assays for Board of Scientific Counselors, the Department of Health and Human their application in epidemiologic National Center for Injury Prevention Services (HHS) announces an studies of pertussis. CDC uses and Control (BSC, NCIPC); Notice of opportunity for commercial epidemiologic, laboratory, clinical, and Charter Renewal; Correction manufacturers to work with CDC’s biostatistical sciences to control and National Center for Immunization and prevent bacterial infectious disease such Notice is hereby given of a change in as pertussis. CDC also conducts applied the Charter Renewal of the Board of Respiratory Diseases (NCIRD) on the validation of pertussis serological kits research in a variety of settings, and Scientific Counselors, National Center translates the findings of this research for Injury Prevention and Control (BSC, prior to submission to the Food and Drug Administration (FDA) for into public health practice. NCIPC), Notice of Charter Renewal marketing authorization. CDC is CDC is working closely with the which was published in the Federal interested in the development of an Council of State and Territorial Register on November 24, 2017, Volume assay that is an Immunoglobulin G (IgG) Epidemiologists (CSTE) to consider 82, Number 225, page 55843. anti-pertussis toxin (PT) enzyme-linked including serology as an appropriate The name of the committee should immunosorbent assay (ELISA), diagnostic tool for confirming a read as follows: Board of Scientific calibrated to an international reference pertussis case. Serology can be very Counselors, National Center for Injury standard (such as FDA Reference useful for diagnosing pertussis in Prevention and Control (BSC, NCIPC) Standard Lot #3, World Health adolescents and adults during the later and the Summary section should read as Organization (WHO) International phases of disease when the current follows: Standard 06/140, or equivalents). The accepted diagnostic methods, culture SUMMARY: This gives notice under the ELISA will be used for in vitro and PCR, are no longer reliable. Federal Advisory Committee Act of serological diagnosis of pertussis in Sensitive and specific quantitative October 6, 1972, that the Board of clinical cases of selected age groups. seroassays have been developed and are Scientific Counselors, National Center CDC will be able to provide guidance, routinely used for diagnosis of pertussis for Injury Prevention and Control (BSC, materials, and evaluation support for world-wide; however, FDA marketing NCIPC), Centers for Disease Control and the manufacturer; however, the authorization is necessary before these Prevention, Department of Health and manufacturer will be responsible for seroassays can be made commercially Human Services, has been renewed for submitting a premarket submission to available as in vitro diagnostics in the a 2-year period through November 5, FDA with adequate information, United States. To date, no quantitative 2019. including any analytical or clinical data pertussis serology kits are commercially FOR FURTHER INFORMATION CONTACT: needed to support the submission, to available in the United States for Gwendolyn H. Cattledge, Ph.D., demonstrate to FDA that FDA can grant diagnostic use. M.S.E.H., Deputy Associate Director for marketing authorization to the product. Interested manufacturers that may Science, NCIPC, CDC, 4770 Buford DATES: CDC is accepting information have candidate products are invited to daltland on DSKBBV9HB2PROD with NOTICES Highway NE, Mailstop F–63, Atlanta, through June 18, 2018. contact CDC to discuss potential GA 30341, Telephone (770) 488–1430. ADDRESSES: You may submit opportunities for collaboration. At a Email address: GCattledge@cdc.gov. information by any of the following minimum, discussions with CDC should The Director, Management Analysis methods: include the following information for and Services Office, has been delegated • Email: PertussisDL@cdc.gov. each candidate product: the authority to sign Federal Register • Mail: Lucia Tondella, National a. Product package insert or detailed notices pertaining to announcements of Center for Immunization and instructions for use. VerDate Sep<11>2014 17:53 Dec 15, 2017 Jkt 244001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\18DEN1.SGM 18DEN1


Document Created: 2017-12-15 23:54:47
Document Modified: 2017-12-15 23:54:47
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 6-7, 2018.
ContactNina Turner, Ph.D., Scientific Review Officer, NIOSH, 1095 Willowdale Road, Morgantown, WV 26506, (304) 285-5976; [email protected]
FR Citation82 FR 60016 
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