83 FR 35004 - Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 142 (July 24, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 142 (July 24, 2018)
| Page Range | 35004-35005 | |
| FR Document | 2018-15781 |
[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)] [Notices] [Pages 35004-35005] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15781] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR) AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by 1,500 web conference lines. Public participants should pre-register for the meeting as described below. The public is welcome to view/listen to the meeting via Adobe Connect. Pre- [[Page 35005]] registration is required by clicking the links below. Web ID: https://adobeconnect.cdc.gov/e3pmwd6fhge/event/registration.html. Dial in number: 888-790-3293 (100 seats). Participant code: 3762458. DATES: The meeting will be held on August 30, 2018, 2:00 p.m. to 5:00 p.m., EDT. ADDRESSES: Web Conference. FOR FURTHER INFORMATION CONTACT: Dometa Ouisley, Office of Science and Public Health Practice, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop D-44, Atlanta, Georgia 30333, Telephone: (404) 639-7450; Fax: (404) 471-8772; Email: OPHPR.BSC.Questions@cdc.gov. SUPPLEMENTARY INFORMATION: Purpose: This Board is charged with providing advice and guidance to the Secretary, Department of Health and Human Services (HHS), the Assistant Secretary for Health (ASH), the Director, Centers for Disease Control and Prevention (CDC), and the Director, Office of Public Health Preparedness and Response (OPHPR), concerning strategies and goals for the programs and research within OPHPR, monitoring the overall strategic direction and focus of the OPHPR Divisions and Offices, and administration and oversight of peer review for OPHPR scientific programs. For additional information about the Board, please visit: http://www.cdc.gov/phpr/science/counselors.htm. Matters to be considered: The agenda will include briefings and BSC deliberation on the following topics: Interval updates from OPHPR Divisions and Offices including responses to issues raised by the Board during the May 2018 in-person BSC meeting; updates from the Biological Agent Containment working group; and proposed agenda items for the October 29-30 2018 in-person BSC meeting. Agenda items are subject to change as priorities dictate. 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. Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2018-15781 Filed 7-23-18; 8:45 am] BILLING CODE 4163-19-P
![35004 Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Number of Hours per Total burden
Form name respondents/ responses response hours
POCs per POC
Eligibility/Registration Form ............................................................................. 70 1 3/60 4
Data Use Agreement ....................................................................................... 70 1 3/60 4
Medical Office Information Form ..................................................................... 70 35 5/60 205
Data Files Submission ..................................................................................... 70 1 1 70
Total .......................................................................................................... NA NA NA 283
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of Average
Total burden Total cost
Form name respondents/ hourly wage
hours burden
POCs rate *
Registration Form ............................................................................................ 70 4 $52.58 $210
Data Use Agreement ....................................................................................... 70 4 52.58 210
Medical Office Information Form ..................................................................... 70 205 52.58 10,779
Data Files Submission ..................................................................................... 70 70 52.58 3,680
Total .......................................................................................................... NA 213 NA 14,880
* Mean hourly wage rate of $52.58 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2016 National
Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100—Offices of Physicians located at https://www.bls.gov/oes/
current/oes119111.htm.
Request for Comments DEPARTMENT OF HEALTH AND Register [82 FR 45027] of the draft
HUMAN SERVICES version of the National Occupational
In accordance with the Paperwork Research Agenda for Construction. All
Reduction Act, comments on AHRQ’s Centers for Disease Control and comments received were reviewed and
information collection are requested Prevention addressed where appropriate.
with regard to any of the following: (a)
[CDC–2017–0084; Docket Number NIOSH– Frank J. Hearl,
Whether the proposed collection of 298]
information is necessary for the proper Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
performance of AHRQ’s health care Final National Occupational Research Disease Control and Prevention.
research and health care information Agenda for Construction
[FR Doc. 2018–15741 Filed 7–23–18; 8:45 am]
dissemination functions, including
AGENCY: National Institute for BILLING CODE 4163–19–P
whether the information will have
Occupational Safety and Health
practical utility; (b) the accuracy of
(NIOSH) of the Centers for Disease
AHRQ’s estimate of burden (including Control and Prevention (CDC), DEPARTMENT OF HEALTH AND
hours and costs) of the proposed Department of Health and Human HUMAN SERVICES
collection(s) of information; (c) ways to Services (HHS).
enhance the quality, utility and clarity Centers for Disease Control and
ACTION: Notice of availability.
of the information to be collected; and Prevention
(d) ways to minimize the burden of the SUMMARY: NIOSH announces the
collection of information upon the Board of Scientific Counselors, Office
availability of the final National
respondents, including the use of of Public Health Preparedness and
Occupational Research Agenda for
Response, (BSC, OPHPR)
automated collection techniques or Construction.
other forms of information technology. DATES: The final document was AGENCY: Centers for Disease Control and
Comments submitted in response to published on July 17, 2018. Prevention (CDC), Department of Health
this notice will be summarized and ADDRESSES: The document may be and Human Services (HHS).
included in the Agency’s subsequent obtained at the following link: https:// ACTION: Notice of meeting.
request for OMB approval of the www.cdc.gov/niosh/nora/councils/
proposed information collection. All const/agenda.html. SUMMARY: In accordance with the
comments will become a matter of FOR FURTHER INFORMATION CONTACT: Federal Advisory Committee Act, the
public record. Emily Novicki, M.A., M.P.H, CDC announces the following meeting
(NORACoordinator@cdc.gov), National for the Board of Scientific Counselors,
Francis D. Chesley, Jr.,
Institute for Occupational Safety and Office of Public Health Preparedness
jstallworth on DSKBBY8HB2PROD with NOTICES
Acting Deputy Director. Health, Centers for Disease Control and and Response, (BSC, OPHPR). This
[FR Doc. 2018–15751 Filed 7–23–18; 8:45 am] Prevention, Mailstop E–20, 1600 Clifton meeting is open to the public, limited
BILLING CODE 4160–90–P Road NE, Atlanta, GA 30329, phone only by 1,500 web conference lines.
(404) 498–2581 (not a toll free number). Public participants should pre-register
SUPPLEMENTARY INFORMATION: On for the meeting as described below.
September 27, 2017, NIOSH published a The public is welcome to view/listen
request for public review in the Federal to the meeting via Adobe Connect. Pre-
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![Federal Register / Vol. 83, No. 142 / Tuesday, July 24, 2018 / Notices 35005
registration is required by clicking the DEPARTMENT OF HEALTH AND 1122, Christopher.Toscano@
links below. HUMAN SERVICES fda.hhs.gov.
Web ID: https:// SUPPLEMENTARY INFORMATION:
adobeconnect.cdc.gov/e3pmwd6fhge/ Food and Drug Administration
event/registration.html. I. Background
[Docket No. FDA–2018–N–0001]
Dial in number: 888–790–3293 (100 Although multiple drugs are known to
seats). Regulatory Perspectives on Otic and cause hearing loss, otic and vestibular
Participant code: 3762458. Vestibular Toxicity: Challenges in toxicities remain a neglected component
DATES: The meeting will be held on Translating Animal Studies to Human in routine drug development. In drug
August 30, 2018, 2:00 p.m. to 5:00 p.m., Risk Assessment; Public Workshop safety evaluations, comparative clinical
EDT. assessments for auditory and vestibular
AGENCY: Food and Drug Administration, systems between animals and humans
ADDRESSES: Web Conference.
HHS. remain largely unexplored. The
FOR FURTHER INFORMATION CONTACT:
ACTION: Notice of public workshop. objective of this public workshop is to
Dometa Ouisley, Office of Science and
Public Health Practice, Centers for identify the challenges involved in the
SUMMARY: The Food and Drug
Disease Control and Prevention, 1600 translation of toxicities from animal
Administration (FDA) is announcing the
Clifton Road NE, Mailstop D–44, toxicology studies to clinical trials, to
following public workshop entitled
Atlanta, Georgia 30333, Telephone: highlight potential endpoints that can
‘‘Regulatory Perspectives on Otic and
(404) 639–7450; Fax: (404) 471–8772; be used in nonclinical and clinical
Vestibular Toxicity: Challenges in
Email: OPHPR.BSC.Questions@cdc.gov. phases of drug development, and to
Translating Animal Studies to Human provide a platform for engaging
SUPPLEMENTARY INFORMATION: Risk Assessment.’’ The purpose of the discussions to improve safety
Purpose: This Board is charged with public workshop is to identify the assessments for ototoxic drugs. This
providing advice and guidance to the challenges involved in the translation of public workshop will bring together
Secretary, Department of Health and toxicities from animal studies to clinical regulatory medical and toxicologist
Human Services (HHS), the Assistant trials, to highlight potential endpoints reviewers, veterinary and clinical
Secretary for Health (ASH), the Director, that can be used in both nonclinical and neurologists, and experts in evaluating
Centers for Disease Control and clinical phases of drug development, auditory and vestibular endpoints.
Prevention (CDC), and the Director, and to provide a platform for engaging
Office of Public Health Preparedness discussions to improve safety II. Topics for Discussion at the Public
and Response (OPHPR), concerning assessments for drugs impacting Workshop
strategies and goals for the programs auditory and vestibular functions. This A regulatory perspective of drug
and research within OPHPR, monitoring public workshop will bring together development and the occurrence of otic
the overall strategic direction and focus regulatory medical and toxicologist and vestibular toxicity will be
of the OPHPR Divisions and Offices, reviewers, veterinary and clinical presented, with a focus on the current
and administration and oversight of neurologists, and experts in evaluating regulatory recommendations on
peer review for OPHPR scientific auditory and vestibular endpoints. assessment of the auditory and
programs. For additional information DATES: The public workshop will be vestibular systems in clinical and
about the Board, please visit: http:// held on August 21, 2018, from 9 a.m. nonclinical studies. Relevant endpoints
www.cdc.gov/phpr/science/ until 12 p.m. See the SUPPLEMENTARY of vestibular and auditory function
counselors.htm. INFORMATION section for registration date (clinical evaluation, non-invasive
Matters to be considered: The agenda and information. electrophysiological measurements, and
will include briefings and BSC ADDRESSES: FDA White Oak Campus, histopathology) will be discussed from
deliberation on the following topics: 10903 New Hampshire Ave., Bldg. 31 a clinical and nonclinical perspective.
Interval updates from OPHPR Divisions Conference Center, the Great Room (Rm. The public workshop will end with an
and Offices including responses to 1503), Silver Spring, MD 20993. open platform discussion between the
issues raised by the Board during the Entrance for the public workshop audience and panelists regarding the
May 2018 in-person BSC meeting; participants (non-FDA employees) is adequacy of the current evaluation and
updates from the Biological Agent through Building 1 where routine potential future approaches towards
Containment working group; and security check procedures will be improving safety assessments for agents
proposed agenda items for the October performed. For parking and security impacting auditory and vestibular
29–30 2018 in-person BSC meeting. information, please refer to https:// functions. We support the principles of
Agenda items are subject to change as www.fda.gov/AboutFDA/ the ‘‘3Rs,’’ to reduce, refine, and replace
priorities dictate. WorkingatFDA/BuildingsandFacilities/ animal use in testing when feasible. We
The Director, Management Analysis WhiteOakCampusInformation/ encourage sponsors to consult with us if
and Services Office, has been delegated ucm241740.htm. it they wish to use a non-animal testing
the authority to sign Federal Register method they believe is suitable,
notices pertaining to announcements of FOR FURTHER INFORMATION CONTACT: adequate, validated, and feasible. We
meetings and other committee Deepa B. Rao, Center for Drug will consider if such an alternative
management activities, for both the Evaluation and Research, Food and method could be assessed for
Centers for Disease Control and Drug Administration, 10903 New equivalency to an animal test method.
Hampshire Ave., Bldg. 22, Rm. 4235,
jstallworth on DSKBBY8HB2PROD with NOTICES
Prevention and the Agency for Toxic III. Participating in the Public
Substances and Disease Registry. Silver Spring, MD 20993, 240–402–
6544, Deepa.Rao@fda.hhs.gov or Workshop
Sherri A. Berger, Christopher D. Toscano, Center for Drug Registration: To register for the public
Chief Operating Officer, Centers for Disease Evaluation and Research, Food and workshop, please visit the following
Control and Prevention. Drug Administration, 10903 New website to register: https://
[FR Doc. 2018–15781 Filed 7–23–18; 8:45 am] Hampshire Ave., Bldg. 22, Rm. 4145, www.eventbrite.com/e/fda-public-
BILLING CODE 4163–19–P Silver Spring, MD 20993, 301–796– workshop-regulatory-perspectives-on-
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Document Created: 2018-07-24 00:10:30
Document Modified: 2018-07-24 00:10:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| Dates | The meeting will be held on August 30, 2018, 2:00 p.m. to 5:00 p.m., EDT. | |
| Contact | Dometa Ouisley, Office of Science and Public Health Practice, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop D-44, Atlanta, Georgia 30333, Telephone: (404) 639-7450; Fax: (404) 471-8772; Email: [email protected] | |
| FR Citation | 83 FR 35004 |
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