83 FR 44883 - Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 171 (September 4, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 171 (September 4, 2018)
| Page Range | 44883-44883 | |
| FR Document | 2018-19077 |
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)] [Notices] [Page 44883] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19077] [[Page 44883]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended, and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)--PAR 13-129, NIOSH Member Conflict Special Emphasis Panel. Date: October 25, 2018. Time: 1:00 p.m.-5:00 p.m. EST. Place: Teleconference. Agenda: To review and evaluate grant applications. For Further Information Contact: Nina Turner, Ph.D., Scientific Review Officer, Office of Extramural Programs, 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. Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2018-19077 Filed 8-31-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 44883
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND • If you want to submit a comment
HUMAN SERVICES HUMAN SERVICES with confidential information that you
do not wish to be made available to the
Centers for Disease Control and Food and Drug Administration public, submit the comment as a
Prevention [Docket No. FDA–2016–D–3969] written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Notice of Closed Meeting Physiologically Based Submissions’’ and ‘‘Instructions’’).
Pharmacokinetic Analyses—Format Written/Paper Submissions
Pursuant to section 10(d) of the and Content; Guidance for Industry;
Federal Advisory Committee Act, as Availability Submit written/paper submissions as
amended, notice is hereby given of the follows:
following meeting. AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
HHS. written/paper submissions): Dockets
The meeting will be closed to the ACTION: Notice of availability. Management Staff (HFA–305), Food and
public in accordance with the Drug Administration, 5630 Fishers
provisions set forth in sections SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Administration (FDA or Agency) is • For written/paper comments
as amended, and the Determination of announcing the availability of a final submitted to the Dockets Management
the Director, Management Analysis and guidance for industry entitled Staff, FDA will post your comment, as
Services Office, CDC, pursuant to Public ‘‘Physiologically Based Pharmacokinetic well as any attachments, except for
Law 92–463. The grant applications and Analyses—Format and Content.’’ This information submitted, marked and
the discussions could disclose guidance outlines the recommended identified, as confidential, if submitted
confidential trade secrets or commercial format and content for a sponsor or as detailed in ‘‘Instructions.’’
applicant to submit physiologically Instructions: All submissions received
property such as patentable material,
based pharmacokinetic (PBPK) analyses must include the Docket No. FDA–
and personal information concerning
to FDA to support applications 2016–D–3969 for ‘‘Physiologically
individuals associated with the grant
including, but not limited to, Based Pharmacokinetic Analyses—
applications, the disclosure of which investigational new drug applications Format and Content.’’ Received
would constitute a clearly unwarranted (INDs), new drug applications (NDAs), comments will be placed in the docket
invasion of personal privacy. biologics license applications (BLAs), or and, except for those submitted as
Name of Committee: Disease, abbreviated new drug applications ‘‘Confidential Submissions,’’ publicly
Disability, and Injury Prevention and (ANDAs). This guidance does not viewable at https://www.regulations.gov
Control Special Emphasis Panel (SEP)— address methodological considerations or at the Dockets Management Staff
PAR 13–129, NIOSH Member Conflict and best practices for the conduct of between 9 a.m. and 4 p.m., Monday
Special Emphasis Panel. PBPK modeling and simulation or the through Friday.
appropriateness of PBPK analyses for a • Confidential Submissions—To
Date: October 25, 2018.
particular drug or a drug product. submit a comment with confidential
Time: 1:00 p.m.–5:00 p.m. EST. DATES: The announcement of the information that you do not wish to be
Place: Teleconference. guidance is published in the Federal made publicly available, submit your
Register on September 4, 2018. comments only as a written/paper
Agenda: To review and evaluate grant
ADDRESSES: You may submit either submission. You should submit two
applications.
electronic or written comments on copies total. One copy will include the
For Further Information Contact: Nina Agency guidances at any time as information you claim to be confidential
Turner, Ph.D., Scientific Review Officer, follows: with a heading or cover note that states
Office of Extramural Programs, 1095 ‘‘THIS DOCUMENT CONTAINS
Willowdale Road, Morgantown, WV Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
26506, (304) 285–5976; nxt2@cdc.gov. Submit electronic comments in the Agency will review this copy, including
The Director, Management Analysis following way: the claimed confidential information, in
and Services Office, has been delegated • Federal eRulemaking Portal: its consideration of comments. The
the authority to sign Federal Register https://www.regulations.gov. Follow the second copy, which will have the
notices pertaining to announcements of instructions for submitting comments. claimed confidential information
Comments submitted electronically, redacted/blacked out, will be available
meetings and other committee
including attachments, to https:// for public viewing and posted on
management activities, for both the
www.regulations.gov will be posted to https://www.regulations.gov. Submit
Centers for Disease Control and the docket unchanged. Because your both copies to the Dockets Management
Prevention and the Agency for Toxic comment will be made public, you are Staff. If you do not wish your name and
Substances and Disease Registry. solely responsible for ensuring that your contact information to be made publicly
Sherri Berger, comment does not include any available, you can provide this
Chief Operating Officer, Centers for Disease confidential information that you or a information on the cover sheet and not
Control and Prevention. third party may not wish to be posted, in the body of your comments and you
[FR Doc. 2018–19077 Filed 8–31–18; 8:45 am]
such as medical information, your or must identify this information as
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4163–18–P
confidential business information, such as ‘‘confidential’’ will not be disclosed
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
that if you include your name, contact and other applicable disclosure law. For
information, or other information that more information about FDA’s posting
identifies you in the body of your of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
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Document Created: 2018-09-01 02:59:37
Document Modified: 2018-09-01 02:59:37
| 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 | |
| Dates | October 25, 2018. | |
| Contact | Nina Turner, Ph.D., Scientific Review Officer, Office of Extramural Programs, 1095 Willowdale Road, Morgantown, WV 26506, (304) 285-5976; [email protected] | |
| FR Citation | 83 FR 44883 |
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