Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID), 61684-61685 [2016-21400]
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61684
Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
mstockstill on DSK3G9T082PROD with NOTICES
Board of Scientific Counselors,
National Institute for Occupational
Safety and Health (BSC, NIOSH)
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 for the
aforementioned committee:
Time and Date: 8:30 a.m.–2:30 p.m.,
EDT, September 27, 2016.
Place: Patriots Plaza I, 395 E Street
SW., Room 9000, Washington, DC
20201. The meeting is also available via
webcast.
Status: This meeting is open to the
public, limited only by the space
available. The meeting room
accommodates approximately 33
people. The public is welcome to
participate during the public comment
period, 12:30 p.m.–12:45 p.m. EDT,
September 27, 2016.
Please note that the public comment
period ends at the time indicated above
or following the last call for comments,
whichever is earlier. Members of the
public who want to comment must sign
up by providing their name by mail,
email, or telephone, at the addresses
provided below by September 23, 2016.
Each commenter will be provided up to
five minutes for comment. A limited
number of time slots are available and
will be assigned on a first come-first
served basis. Written comments will
also be accepted from those unable to
attend the public session via an on-line
form at the following Web site: https://
www.cdc.gov/niosh/bsc/contact.html.
The meeting is also open to the public
via webcast. If you wish to attend in
person or by webcast, please see the
NIOSH Web site to register (https://
www.cdc.gov/niosh/bsc/) or call (404–
498–2539) at least five business days in
advance of the meeting. Teleconference
is available toll-free; please dial (888)
397–9578, Participant Pass Code
63257516. Adobe Connect webcast will
be available at https://
odniosh.adobeconnect.com/nioshbsc/
for participants wanting to connect
remotely.
Purpose: The Secretary, the Assistant
Secretary for Health, and by delegation
the Director, Centers for Disease Control
and Prevention, are authorized under
Sections 301 and 308 of the Public
Health Service Act to conduct directly
or by grants or contracts, research,
experiments, and demonstrations
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18:44 Sep 06, 2016
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relating to occupational safety and
health and to mine health. The Board of
Scientific Counselors provides guidance
to the Director, National Institute for
Occupational Safety and Health on
research and prevention programs.
Specifically, the Board provides
guidance on the Institute’s research
activities related to developing and
evaluating hypotheses, systematically
documenting findings and
disseminating results. The Board
evaluates the degree to which the
activities of the National Institute for
Occupational Safety and Health: (1)
conform to appropriate scientific
standards, (2) address current, relevant
needs, and (3) produce intended results.
Matters for Discussion: NIOSH
Director’s update; Chronic Kidney
Disease and Pesticide Exposure; NIOSH
Oil and Gas Sector Program;
Engineering Controls for Additive (3D)
Manufacturing, and Engineering
Controls and Nanomaterials.
Agenda items are subject to change as
priorities dictate.
An agenda is also posted on the
NIOSH Web site (https://www.cdc.gov/
niosh/bsc/). Members of the public who
wish to address the NIOSH BSC are
requested to contact the Executive
Secretary for scheduling purposes (see
contact information below).
Alternatively, written comments to the
BSC may be submitted via an on-line
form at the following Web site: https://
www.cdc.gov/niosh/bsc/contact.html.
Contact Person for More Information:
Paul J. Middendorf, Ph.D., Executive
Secretary, BSC, NIOSH, CDC, 1600
Clifton Road NE., MS–E20, Atlanta, GA
30329–4018, telephone (404) 498–2500,
fax (404) 498–2526.
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, MPH, DLP,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
[FR Doc. 2016–21399 Filed 9–6–16; 8:45 am]
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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.
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61685
Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
Elaine L. Baker, MPH, DLP,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0607. Also
include the FDA docket number found
in brackets in the heading of this
document.
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2016–21400 Filed 9–6–16; 8:45 am]
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[Docket No. FDA–2013–N–0514]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requests for
Clinical Laboratory Improvement
Amendments Categorization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 7,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Requests for Clinical Laboratory
Improvement Amendments of 1988
Categorization—42 CFR 493.17—OMB
Control Number 0910–0607—Extension
A guidance document entitled
‘‘Guidance for Administrative
Procedures for CLIA Categorization’’
was released on May 7, 2008. The
document describes procedures FDA
uses to assign the complexity category
to a device. Typically, FDA assigns
complexity categorizations to devices at
the time of clearance or approval of the
device. In this way, no additional
burden is incurred by the manufacturer
because the labeling (including
operating instructions) is included in
the premarket notification (510(k)) or
premarket approval application (PMA).
In some cases, however, a manufacturer
may request Clinical Laboratory
Improvement Amendments of 1998
(CLIA) categorization even if FDA is not
simultaneously reviewing a 510(k) or
PMA. One example is when a
manufacturer requests that FDA assign
CLIA categorization to a previously
cleared device that has changed names
since the original CLIA categorization.
Another example is when a device is
exempt from premarket review. In such
cases, the guidance recommends that
manufacturers provide FDA with a copy
of the package insert for the device and
a cover letter indicating why the
manufacturer is requesting a
categorization (e.g. name change,
exempt from 510(k) review). The
guidance recommends that in the
correspondence to FDA the
manufacturer should identify the
product code and classification as well
as reference to the original 510(k) when
this is available.
In the Federal Register of April 27,
2016 (81 FR 24820), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Request for CLIA Categorization .............
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1
Number of
responses per
respondent
60
Total annual
responses
15
Average
burden per
response
900
Total hours
1
Total operating
and
maintenance
costs
900
$46,800
There are no capital costs associated with this collection of information.
The number of respondents is
approximately 60. On average, each
respondent will request categorizations
(independent of a 510(k) or PMA) 15
times per year. The cost, not including
personnel, is estimated at $52 per hour
(52 × 900), totaling $46,800. This
includes the cost of copying and mailing
copies of package inserts and a cover
letter, which includes a statement of the
reason for the request and reference to
the original 510(k) numbers, including
regulation numbers and product codes.
The burden hours are based on FDA
familiarity with the types of
documentation typically included in a
sponsor’s categorization requests, and
costs for basic office supplies (e.g.,
paper).
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Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21352 Filed 9–6–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0731]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61684-61685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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]
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