81 FR 62508 - Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 175 (September 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 175 (September 9, 2016)
| Page Range | 62508-62509 | |
| FR Document | 2016-21688 |
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)] [Notices] [Pages 62508-62509] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21688] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. DATES: The meeting will be held on November 1, 2016, from 8 a.m. to 5:30 p.m., and on November 2, 2016, from 8 a.m. to 11:40 a.m. ADDRESSES: Crowne Plaza Hotel, 201 S. Shackleford Rd., Little Rock, AR 72211. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301- 796-8892 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On November 1, 2016, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Bioinformatics and Biostatistics Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be the public comment session and an update from the NCTR Research Divisions. On November 2, 2016, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Office of Food and Veterinary Medicine, Center for Tobacco Products, and the Center for Veterinary Medicine will each briefly discuss their center-specific research strategic needs and potential areas of collaboration. Following an open discussion of all the information presented, the open session of the meeting will close so the SAB members can discuss personnel issues at NCTR at the end of each day. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On November 1, 2016, from 8 a.m. to 5:30 p.m., and November 2, 2016, from 8 a.m. to 11:40 a.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 25, 2016. Oral presentations from the public will be scheduled on November 1, 2016, between approximately 1:15 p.m. to 2:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 17, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 18, 2016. Closed Committee Deliberations: On November 1, 2016, from 5:30 p.m. to 6 p.m., and November 2, 2016, from 11:40 a.m. to 12:15 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be closed to permit discussion of information concerning individuals associated with the research programs at NCTR. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Donna Mendrick at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on [[Page 62509]] public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-21688 Filed 9-8-16; 8:45 am] BILLING CODE 4164-01-P
![62508 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
This draft guidance is being issued AdvisoryCommittees/ AdvisoryCommittees/Calendar/
consistent with FDA’s good guidance AboutAdvisoryCommittees/ default.htm. Scroll down to the
practices regulation (21 CFR 10.115). ucm408555.htm. appropriate advisory committee meeting
The draft guidance, when finalized, will FOR FURTHER INFORMATION CONTACT: link.
represent the current thinking of FDA Donna Mendrick, National Center for Procedure: On November 1, 2016,
on ‘‘E17 General Principles for Planning Toxicological Research, Food and Drug from 8 a.m. to 5:30 p.m., and November
and Design of Multi-Regional Clinical Administration, 10903 New Hampshire 2, 2016, from 8 a.m. to 11:40 a.m., the
Trials.’’ It does not establish any rights Ave., Bldg. 32, Rm. 2208, Silver Spring, meeting is open to the public. Interested
for any person and is not binding on MD 20993–0002, 301–796–8892 or FDA persons may present data, information,
FDA or the public. You can use an Advisory Committee Information Line, or views, orally or in writing, on issues
alternative approach if it satisfies the 1–800–741–8138 (301–443–0572 in the pending before the committee. Written
requirements of the applicable statutes Washington, DC area). A notice in the submissions may be made to the contact
and regulations. Federal Register about last minute person on or before October 25, 2016.
modifications that impact a previously Oral presentations from the public will
II. Electronic Access
announced advisory committee meeting be scheduled on November 1, 2016,
Persons with access to the Internet cannot always be published quickly between approximately 1:15 p.m. to
may obtain the document at http:// enough to provide timely notice. 2:15 p.m. Those individuals interested
www.regulations.gov, http:// Therefore, you should always check the in making formal oral presentations
www.fda.gov/Drugs/Guidance Agency’s Web site at http:// should notify the contact person and
ComplianceRegulatoryInformation/ www.fda.gov/AdvisoryCommittees/ submit a brief statement of the general
Guidances/default.htm, or http:// default.htm and scroll down to the nature of the evidence or arguments
www.fda.gov/BiologicsBloodVaccines/ appropriate advisory committee meeting they wish to present, the names and
GuidanceComplianceRegulatory link, or call the advisory committee addresses of proposed participants, and
Information/Guidances/default.htm. information line to learn about possible an indication of the approximate time
Dated: September 2, 2016. modifications before coming to the requested to make their presentation on
Leslie Kux, meeting. or before October 17, 2016. Time
Associate Commissioner for Policy. allotted for each presentation may be
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–21689 Filed 9–8–16; 8:45 am] Agenda: On November 1, 2016, the limited. If the number of registrants
SAB Chair will welcome the requesting to speak is greater than can
BILLING CODE 4164–01–P
participants, and the NCTR Director will be reasonably accommodated during the
provide a Center-wide update on scheduled open public hearing session,
DEPARTMENT OF HEALTH AND scientific initiatives and FDA may conduct a lottery to determine
HUMAN SERVICES accomplishments during the past year. the speakers for the scheduled open
The SAB will be presented with an public hearing session. The contact
Food and Drug Administration overview of the Division of person will notify interested persons
Bioinformatics and Biostatistics regarding their request to speak by
[Docket No. FDA–2016–N–0001]
Subcommittee and the Subcommittee October 18, 2016.
Science Advisory Board to the Site Visit Report and a response to this Closed Committee Deliberations: On
National Center for Toxicological review. There will be the public November 1, 2016, from 5:30 p.m. to 6
Research Advisory Committee; Notice comment session and an update from p.m., and November 2, 2016, from 11:40
of Meeting the NCTR Research Divisions. a.m. to 12:15 p.m., the meeting will be
On November 2, 2016, the Center for closed to permit discussion where
AGENCY: Food and Drug Administration, Biologics and Evaluation and Research, disclosure would constitute a clearly
HHS. Center for Drug Evaluation and unwarranted invasion of personal
ACTION: Notice. Research, Center for Devices and privacy (5 U.S.C. 552b(c)(6)). This
Radiological Health, Office of Food and portion of the meeting will be closed to
SUMMARY: The Food and Drug permit discussion of information
Veterinary Medicine, Center for Tobacco
Administration (FDA) announces a concerning individuals associated with
Products, and the Center for Veterinary
forthcoming public advisory committee the research programs at NCTR.
Medicine will each briefly discuss their
meeting of the Science Advisory Board Persons attending FDA’s advisory
center-specific research strategic needs
(SAB) to the National Center for committee meetings are advised that the
and potential areas of collaboration.
Toxicological Research (NCTR). The Following an open discussion of all Agency is not responsible for providing
general function of the committee is to the information presented, the open access to electrical outlets.
provide advice and recommendations to session of the meeting will close so the FDA welcomes the attendance of the
the Agency on FDA’s regulatory issues. SAB members can discuss personnel public at its advisory committee
At least one portion of the meeting will issues at NCTR at the end of each day. meetings and will make every effort to
be closed to the public. FDA intends to make background accommodate persons with disabilities.
DATES: The meeting will be held on material available to the public no later If you require accommodations due to a
November 1, 2016, from 8 a.m. to 5:30 than 2 business days before the meeting. disability, please contact Donna
p.m., and on November 2, 2016, from 8 If FDA is unable to post the background Mendrick at least 7 days in advance of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
a.m. to 11:40 a.m. material on its Web site prior to the the meeting.
ADDRESSES: Crowne Plaza Hotel, 201 S. meeting, the background material will FDA is committed to the orderly
Shackleford Rd., Little Rock, AR 72211. be made publicly available at the conduct of its advisory committee
Answers to commonly asked questions location of the advisory committee meetings. Please visit our Web site at
including information regarding special meeting, and the background material http://www.fda.gov/
accommodations due to a disability, will be posted on FDA’s Web site after AdvisoryCommittees/
visitor parking, and transportation may the meeting. Background material is AboutAdvisoryCommittees/
be accessed at: http://www.fda.gov/ available at http://www.fda.gov/ ucm111462.htm for procedures on
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![Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices 62509
public conduct during advisory the docket unchanged. Because your for public viewing and posted on http://
committee meetings. comment will be made public, you are www.regulations.gov. Submit both
Notice of this meeting is given under solely responsible for ensuring that your copies to the Division of Dockets
the Federal Advisory Committee Act (5 comment does not include any Management. If you do not wish your
U.S.C. app. 2). confidential information that you or a name and contact information to be
Dated: September 2, 2016. third party may not wish to be posted, made publicly available, you can
Leslie Kux,
such as medical information, your or provide this information on the cover
anyone else’s Social Security number, or sheet and not in the body of your
Associate Commissioner for Policy.
confidential business information, such comments and you must identify this
[FR Doc. 2016–21688 Filed 9–8–16; 8:45 am] as a manufacturing process. Please note information as ‘‘confidential.’’ Any
BILLING CODE 4164–01–P that if you include your name, contact information marked as ‘‘confidential’’
information, or other information that will not be disclosed except in
identifies you in the body of your accordance with 21 CFR 10.20 and other
DEPARTMENT OF HEALTH AND comments, that information will be applicable disclosure law. For more
HUMAN SERVICES posted on http://www.regulations.gov. information about FDA’s posting of
• If you want to submit a comment comments to public dockets, see 80 FR
Food and Drug Administration
with confidential information that you 56469, September 18, 2015, or access
[Docket No. FDA–2016–D–2241] do not wish to be made available to the the information at http://www.fda.gov/
public, submit the comment as a regulatoryinformation/dockets/
Substantiation for Structure/Function written/paper submission and in the default.htm.
Claims Made in Infant Formula Labels manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
and Labeling: Draft Guidance for Submissions’’ and ‘‘Instructions’’). read background documents or the
Industry; Availability electronic and written/paper comments
Written/Paper Submissions
AGENCY: Food and Drug Administration, received, go to http://
Submit written/paper submissions as www.regulations.gov and insert the
HHS. follows: docket number, found in brackets in the
ACTION: Notice of availability. • Mail/Hand delivery/Courier (for
heading of this document, into the
written/paper submissions): Division of
SUMMARY: The Food and Drug ‘‘Search’’ box and follow the prompts
Dockets Management (HFA–305), Food
Administration (FDA or we) is and/or go to the Division of Dockets
and Drug Administration, 5630 Fishers
announcing the availability of a draft Management, 5630 Fishers Lane, Rm.
Lane, Rm. 1061, Rockville, MD 20852.
guidance for industry entitled • For written/paper comments 1061, Rockville, MD 20852.
‘‘Substantiation for Structure/Function Submit written requests for single
submitted to the Division of Dockets
Claims Made in Infant Formula Labels copies of the draft guidance to the Office
Management, FDA will post your
and Labeling.’’ The draft guidance, of Nutrition and Food Labeling, Center
comment, as well as any attachments,
when finalized, will describe the type for Food Safety and Applied Nutrition
except for information submitted,
and quality of evidence that we (HFS–800), Food and Drug
marked and identified, as confidential,
recommend that infant formula Administration, 5001 Campus Dr.,
if submitted as detailed in
manufacturers and distributors have to College Park, MD 20740. Send two self-
‘‘Instructions.’’
substantiate structure/function claims in Instructions: All submissions received addressed adhesive labels to assist that
infant formula labels and labeling. This must include the Docket No. FDA– office in processing your request. See
draft guidance is intended to help infant 2016–D–2241 for ‘‘Substantiation for the SUPPLEMENTARY INFORMATION section
formula manufacturers making Structure/Function Claims Made in for electronic access to the draft
structure/function claims comply with Infant Formula Labels and Labeling.’’ guidance.
the statutory requirement that all claims Received comments will be placed in FOR FURTHER INFORMATION CONTACT:
in infant formula labeling must be the docket and, except for those With regard to this draft guidance:
truthful and not misleading under the submitted as ‘‘Confidential Gillian Robert-Baldo, Center for Food
Federal Food, Drug, and Cosmetic Act Submissions,’’ publicly viewable at Safety and Applied Nutrition (HFS–
(the FD&C Act). http://www.regulations.gov or at the 850), Food and Drug Administration,
DATES: Although you can comment on Division of Dockets Management 5001 Campus Dr., College Park, MD
any guidance at any time (see 21 CFR between 9 a.m. and 4 p.m., Monday 20740, 240–402–1451.
10.115(g)(5)), to ensure that we consider through Friday. With regard to the information
your comment on the draft guidance • Confidential Submissions—To collection issues: Domini Bean, Office of
before we begin work on the final submit a comment with confidential Information Management, Food and
version of the guidance, submit either information that you do not wish to be Drug Administration, 1350 Piccard Dr.,
electronic or written comments on the made publicly available, submit your PI50–400T, Rockville, MD 20850,
draft guidance by November 8, 2016. comments only as a written/paper domini.bean@fda.hhs.gov.
ADDRESSES: You may submit comments submission. You should submit two SUPPLEMENTARY INFORMATION:
as follows: copies total. One copy will include the
information you claim to be confidential I. Background
Electronic Submissions with a heading or cover note that states We are announcing the availability of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS a draft guidance for industry entitled
following way: CONFIDENTIAL INFORMATION.’’ The ‘‘Substantiation for Structure/Function
• Federal eRulemaking Portal: http:// Agency will review this copy, including Claims Made in Infant Formula Labels
www.regulations.gov. Follow the the claimed confidential information, in and Labeling.’’ We are issuing this draft
instructions for submitting comments. its consideration of comments. The guidance consistent with our good
Comments submitted electronically, second copy, which will have the guidance practices regulation (21 CFR
including attachments, to http:// claimed confidential information 10.115). The draft guidance, when
www.regulations.gov will be posted to redacted/blacked out, will be available finalized, will represent our current
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Document Created: 2018-02-09 13:14:54
Document Modified: 2018-02-09 13:14:54
| 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. | |
| Dates | The meeting will be held on November 1, 2016, from 8 a.m. to 5:30 p.m., and on November 2, 2016, from 8 a.m. to 11:40 a.m. | |
| Contact | Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301- 796-8892 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 81 FR 62508 |
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