Notice of Closed Meeting, 60016-60017 [2017-27165]
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be addressed to Christine M.
Todaro, Attorney, Division of Marketing
Practices, Bureau of Consumer
Protection, Federal Trade Commission,
600 Pennsylvania Avenue NW,
CC–8528, Washington, DC 20580, (202)
326–3711.
SUPPLEMENTARY INFORMATION: On
September 28, 2017, the FTC sought
public comment on the information
collection requirements associated with
the Rule (September 28, 2017 Notice 1),
16 CFR part 437 (OMB Control Number
3084–0142). No relevant comments
were received. Pursuant to the OMB
regulations, 5 CFR part 1320, that
implement the PRA, 44 U.S.C. 3501 et
seq., the FTC is providing this second
opportunity for public comment while
seeking OMB approval to renew the preexisting clearance for the Rule.
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Burden Statement
As detailed in the September 28, 2017
Notice, the FTC estimates cumulative
annual burden on affected entities to be
10,065 hours, $2,516,250 in labor costs,
and $3,062,224 in non-labor costs.
Request for Comment
You can file a comment online or on
paper. For the FTC to consider your
comment, we must receive it on or
before January 17, 2018. Write
‘‘Business Opportunity Rule Paperwork
Comment, FTC File No. P114408’’ on
your comment. Your comment—
including your name and your state—
will be placed on the public record of
this proceeding, including, to the extent
practicable, on the public Commission
website, at https://www.ftc.gov/os/
publiccomments.shtm.
Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online, or to send them to the
Commission by courier or overnight
service. To make sure that the
Commission considers your online
comment, you must file it at https://
ftcpublic.commentworks.com/ftc/
tobaccoreportspra, by following the
instructions on the web-based form.
When this Notice appears at https://
www.regulations.gov/#!home, you also
may file a comment through that
website.
If you file your comment on paper,
write ‘‘Business Opportunity Rule
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FR 45288.
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17:53 Dec 15, 2017
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Paperwork Comment, FTC File No.
P114408’’ on your comment and on the
envelope, and mail it to the following
address: Federal Trade Commission,
Office of the Secretary, 600
Pennsylvania Avenue NW, Suite CC–
5610 (Annex J), Washington, DC 20580,
or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
Because your comment will be placed
on the publicly accessible FTC website
at https://www.ftc.gov/, you are solely
responsible for making sure that your
comment does not include any sensitive
or confidential information. In
particular, your comment should not
include any sensitive personal
information, such as your or anyone
else’s Social Security number; date of
birth; driver’s license number or other
state identification number, or foreign
country equivalent; passport number;
financial account number; or credit or
debit card number. You are also solely
responsible for making sure that your
comment does not include any sensitive
health information, such as medical
records or other individually
identifiable health information. In
addition, your comment should not
include any ‘‘trade secret or any
commercial or financial information
which . . . is privileged or
confidential’’—as provided by Section
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—
including in particular competitively
sensitive information such as costs,
sales statistics, inventories, formulas,
patterns, devices, manufacturing
processes, or customer names.
Comments containing material for
which confidential treatment is
requested must be filed in paper form,
must be clearly labeled ‘‘Confidential,’’
and must comply with FTC Rule 4.9(c).
In particular, the written request for
confidential treatment that accompanies
the comment must include the factual
and legal basis for the request, and must
identify the specific portions of the
comment to be withheld from the public
record. See FTC Rule 4.9(c). Your
comment will be kept confidential only
if the General Counsel grants your
request in accordance with the law and
the public interest. Once your comment
has been posted on the public FTC
website—as legally required by FTC
Rule 4.9(b)—we cannot redact or
remove your comment from the FTC
website, unless you submit a
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confidentiality request that meets the
requirements for such treatment under
FTC Rule 4.9(c), and the General
Counsel grants that request.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before January 17, 2018. For information
on the Commission’s privacy policy,
including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/
site-information/privacy-policy.
Comments on the information
collection requirements subject to
review under the PRA should
additionally be submitted to OMB. If
sent by U.S. mail, they should be
addressed to Office of Information and
Regulatory Affairs, Office of
Management and Budget, Attention:
Desk Officer for the Federal Trade
Commission, New Executive Office
Building, Docket Library, Room 10102,
725 17th Street NW, Washington, DC
20503. Comments sent to OMB by U.S.
postal mail are subject to delays due to
heightened security precautions. Thus,
comments instead can also be sent via
email to wliberante@omb.eop.gov.
David C. Shonka,
Acting General Counsel.
[FR Doc. 2017–27207 Filed 12–15–17; 8:45 am]
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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
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Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
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; nturner@cdc.gov.
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
The Centers for Disease
Control and Prevention (CDC) within
the Department of Health and Human
Services (HHS) announces an
opportunity for commercial
manufacturers to work with CDC’s
National Center for Immunization and
Respiratory Diseases (NCIRD) on the
validation of pertussis serological kits
prior to submission to the Food and
Drug Administration (FDA) for
marketing authorization. CDC is
interested in the development of an
assay that is an Immunoglobulin G (IgG)
anti-pertussis toxin (PT) enzyme-linked
immunosorbent assay (ELISA),
calibrated to an international reference
standard (such as FDA Reference
Standard Lot #3, World Health
Organization (WHO) International
Standard 06/140, or equivalents). The
ELISA will be used for in vitro
serological diagnosis of pertussis in
clinical cases of selected age groups.
CDC will be able to provide guidance,
materials, and evaluation support for
the manufacturer; however, the
manufacturer will be responsible for
submitting a premarket submission to
FDA with adequate information,
including any analytical or clinical data
needed to support the submission, to
demonstrate to FDA that FDA can grant
marketing authorization to the product.
DATES: CDC is accepting information
through June 18, 2018.
ADDRESSES: You may submit
information by any of the following
methods:
• Email: PertussisDL@cdc.gov.
• Mail: Lucia Tondella, National
Center for Immunization and
SUMMARY:
Board of Scientific Counselors,
National Center for Injury Prevention
and Control (BSC, NCIPC); Notice of
Charter Renewal; Correction
Notice is hereby given of a change in
the Charter Renewal of the Board of
Scientific Counselors, National Center
for Injury Prevention and Control (BSC,
NCIPC), Notice of Charter Renewal
which was published in the Federal
Register on November 24, 2017, Volume
82, Number 225, page 55843.
The name of the committee should
read as follows: Board of Scientific
Counselors, National Center for Injury
Prevention and Control (BSC, NCIPC)
and the Summary section should read as
follows:
SUMMARY: This gives notice under the
Federal Advisory Committee Act of
October 6, 1972, that the Board of
Scientific Counselors, National Center
for Injury Prevention and Control (BSC,
NCIPC), Centers for Disease Control and
Prevention, Department of Health and
Human Services, has been renewed for
a 2-year period through November 5,
2019.
FOR FURTHER INFORMATION CONTACT:
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Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
Centers for Disease Control and
Prevention
Gwendolyn H. Cattledge, Ph.D.,
M.S.E.H., Deputy Associate Director for
Science, NCIPC, CDC, 4770 Buford
Highway NE, Mailstop F–63, Atlanta,
GA 30341, Telephone (770) 488–1430.
Email address: GCattledge@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
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[FR Doc. 2017–27164 Filed 12–15–17; 8:45 am]
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
17:53 Dec 15, 2017
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Invitation to Manufacturers of
Pertussis Serological Kits
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meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
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Respiratory Diseases, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mail Stop D–11,
Atlanta, GA 30329.
FOR FURTHER INFORMATION CONTACT:
For Technical Questions: Lucia
Tondella, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mail
Stop D–11, Atlanta, GA 30329. Phone:
404–639–1239, Email: PertussisDL@
cdc.gov.
For Business Questions: Jason
Cloward, Technology Transfer Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mail
Stop E–51, Atlanta, GA 30329. Phone:
404–639–2679, Email: wnv3@cdc.gov.
SUPPLEMENTARY INFORMATION: CDC’s
National Center for Immunization and
Respiratory Diseases (NCIRD), Division
of Bacterial Diseases (DBD), Meningitis
and Vaccine Preventable Diseases
Branch (MVPDB) has lead technical
responsibility for research, development
and evaluation of diagnostic assays for
their application in epidemiologic
studies of pertussis. CDC uses
epidemiologic, laboratory, clinical, and
biostatistical sciences to control and
prevent bacterial infectious disease such
as pertussis. CDC also conducts applied
research in a variety of settings, and
translates the findings of this research
into public health practice.
CDC is working closely with the
Council of State and Territorial
Epidemiologists (CSTE) to consider
including serology as an appropriate
diagnostic tool for confirming a
pertussis case. Serology can be very
useful for diagnosing pertussis in
adolescents and adults during the later
phases of disease when the current
accepted diagnostic methods, culture
and PCR, are no longer reliable.
Sensitive and specific quantitative
seroassays have been developed and are
routinely used for diagnosis of pertussis
world-wide; however, FDA marketing
authorization is necessary before these
seroassays can be made commercially
available as in vitro diagnostics in the
United States. To date, no quantitative
pertussis serology kits are commercially
available in the United States for
diagnostic use.
Interested manufacturers that may
have candidate products are invited to
contact CDC to discuss potential
opportunities for collaboration. At a
minimum, discussions with CDC should
include the following information for
each candidate product:
a. Product package insert or detailed
instructions for use.
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[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60016-60017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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