81 FR 85978 - Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Establishment of a Public Docket; Request for Comments; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 229 (November 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 229 (November 29, 2016)
| Page Range | 85978-85980 | |
| FR Document | 2016-28605 |
[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)] [Notices] [Pages 85978-85980] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28605] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0067] Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Establishment of a Public Docket; Request for Comments; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on March 15, 2017, from 7:30 a.m. to 3:45 p.m. ADDRESSES: Omni Shoreham Hotel, the Ballroom, 2500 Calvert St. NW., Washington, DC 20008. The hotel telephone number is 202-234-0700. 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. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, [[Page 85979]] including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2010-N-0067 for ``Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, [email protected], 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: The use of model-informed drug development (MIDD) for new and generic drugs has significantly increased over the past several years. The committee will discuss strategies, approaches, and challenges in MIDD with specific focus on two areas. During the morning session, the committee will discuss approaches and evidentiary information needed for applying physiologically-based pharmacokinetic modeling and simulation throughout a drug's lifecycle. During the afternoon session, the committee will discuss mechanistic model- informed safety evaluation with a focus on drug potential for causing arrhythmias. The Comprehensive in Vitro Proarrhythmia Assay will be discussed as an exemplar. 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: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before March 1, 2017, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 9:50 a.m. to 10:20 a.m. and 2:15 p.m. to 2:45 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 February 21, 2017. 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 February 22, 2017. 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 Jennifer [[Page 85980]] Shepherd 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 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: November 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-28605 Filed 11-28-16; 8:45 am] BILLING CODE 4164-01-P
![85978 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
published September 14, 2016 (81 FR made publicly available, submit your FDA has considered the requests and
63187). Submit either electronic or comments only as a written/paper is extending the comment period for 90
written comments by March 13, 2017. submission. You should submit two additional days, until March 13, 2017.
ADDRESSES: You may submit comments copies total. One copy will include the The Agency believes that a 90-day
as follows: information you claim to be confidential extension allows adequate time for
with a heading or cover note that states interested persons to submit comments
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS without significantly delaying FDA’s
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The consideration of these important issues.
following way: Agency will review this copy, including Dated: November 22, 2016.
• Federal eRulemaking Portal: http:// the claimed confidential information, in
www.regulations.gov. Follow the Leslie Kux,
its consideration of comments. The
instructions for submitting comments. Associate Commissioner for Policy.
second copy, which will have the
Comments submitted electronically, claimed confidential information [FR Doc. 2016–28660 Filed 11–28–16; 8:45 am]
including attachments, to http:// redacted/blacked out, will be available BILLING CODE 4164–01–P
www.regulations.gov will be posted to for public viewing and posted on http://
the docket unchanged. Because your www.regulations.gov. Submit both
comment will be made public, you are copies to the Division of Dockets DEPARTMENT OF HEALTH AND
solely responsible for ensuring that your Management. If you do not wish your HUMAN SERVICES
comment does not include any name and contact information to be Food and Drug Administration
confidential information that you or a made publicly available, you can
third party may not wish to be posted, provide this information on the cover [Docket No. FDA–2010–N–0067]
such as medical information, your or sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this Pharmaceutical Science and Clinical
confidential business information, such information as ‘‘confidential.’’ Any Pharmacology Advisory Committee;
as a manufacturing process. Please note information marked as ‘‘confidential’’ Establishment of a Public Docket;
that if you include your name, contact will not be disclosed except in Request for Comments; Notice of
information, or other information that accordance with 21 CFR 10.20 and other Meeting
identifies you in the body of your applicable disclosure law. For more AGENCY: Food and Drug Administration,
comments, that information will be information about FDA’s posting of HHS.
posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment ACTION: Notice of public meeting;
56469, September 18, 2015, or access establishment of a public docket;
with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the request for comments.
regulatoryinformation/dockets/
public, submit the comment as a default.htm. SUMMARY: The Food and Drug
written/paper submission and in the Docket: For access to the docket to Administration (FDA) announces a
manner detailed (see ‘‘Written/Paper read background documents or the forthcoming public advisory committee
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments meeting of the Pharmaceutical Science
Written/Paper Submissions received, go to http:// and Clinical Pharmacology Advisory
www.regulations.gov and insert the Committee. The general function of the
Submit written/paper submissions as docket number, found in brackets in the committee is to provide advice and
follows: heading of this document, into the
• Mail/Hand delivery/Courier (for recommendations to the Agency on
‘‘Search’’ box and follow the prompts FDA’s regulatory issues. The meeting
written/paper submissions): Division of and/or go to the Division of Dockets
Dockets Management (HFA–305), Food will be open to the public.
Management, 5630 Fishers Lane, Rm. DATES: The meeting will be held on
and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. March 15, 2017, from 7:30 a.m. to 3:45
FOR FURTHER INFORMATION CONTACT:
• For written/paper comments p.m.
submitted to the Division of Dockets Cindy Burnsteel, Center for Veterinary ADDRESSES: Omni Shoreham Hotel, the
Management, FDA will post your Medicine (HFV–130), Food and Drug Ballroom, 2500 Calvert St. NW.,
comment, as well as any attachments, Administration, 7500 Standish Pl., Washington, DC 20008. The hotel
except for information submitted, Rockville, MD 20855, 240–402–0817, telephone number is 202–234–0700.
marked and identified, as confidential, cindy.burnsteel@fda.hhs.gov. Answers to commonly asked questions
if submitted as detailed in SUPPLEMENTARY INFORMATION: In the including information regarding special
‘‘Instructions.’’ Federal Register of September 14, 2016 accommodations due to a disability,
Instructions: All submissions received (81 FR 63187), FDA solicited comments visitor parking, and transportation may
must include the Docket No. FDA– regarding the establishment of be accessed at: http://www.fda.gov/
2016–D–2635 for ‘‘Establishing appropriate durations of use of AdvisoryCommittees/
Appropriate Durations of Therapeutic antimicrobial drugs of importance to AboutAdvisoryCommittees/
Administration.’’ Received comments human medicine when administered in ucm408555.htm.
will be placed in the docket and, except the feed or water of food-producing You may submit comments as
for those submitted as ‘‘Confidential animals for therapeutic purposes with a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
follows:
Submissions,’’ publicly viewable at 90-day comment period.
http://www.regulations.gov or at the The Agency has received requests for Electronic Submissions
Division of Dockets Management an extension of the comment period. Submit electronic comments in the
between 9 a.m. and 4 p.m., Monday These requests conveyed concern that following way:
through Friday. the current 90-day comment period does • Federal eRulemaking Portal: http://
• Confidential Submissions—To not allow sufficient time to develop a www.regulations.gov. Follow the
submit a comment with confidential meaningful or thoughtful response to instructions for submitting comments.
information that you do not wish to be the request for comments. Comments submitted electronically,
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![85980 Federal Register / Vol. 81, No. 229 / Tuesday, November 29, 2016 / Notices
Shepherd at least 7 days in advance of SUPPLEMENTARY INFORMATION: The DEPARTMENT OF HEALTH AND
the meeting. CFSAC is authorized under 42 U.S.C. HUMAN SERVICES
FDA is committed to the orderly 217a, Section 222 of the Public Health
conduct of its advisory committee Service Act, as amended. The purpose National Institutes of Health
meetings. Please visit our Web site at of the CFSAC is to provide advice and
http://www.fda.gov/ recommendations to the Secretary of Government-Owned Inventions;
AdvisoryCommittees/ Health and Human Services, through Availability for Licensing and
AboutAdvisoryCommittees/ the Assistant Secretary for Health on Collaboration
ucm111462.htm for procedures on topics related to myalgic AGENCY: National Institutes of Health,
public conduct during advisory encephalomyelitis/chronic fatigue HHS.
committee meetings. syndrome (ME/CFS). The issues can
Notice of this meeting is given under ACTION: Notice.
include factors affecting access and care
the Federal Advisory Committee Act (5 for persons with ME/CFS; the science SUMMARY: The invention listed below is
U.S.C. app. 2). and definition of ME/CFS; and broader owned by an agency of the U.S.
Dated: November 22, 2016. public health, clinical, research, and Government and is available for
Leslie Kux, educational issues related to ME/CFS. licensing and/or co-development to
Associate Commissioner for Policy. The agenda for this meeting, call-in achieve expeditious commercialization
[FR Doc. 2016–28605 Filed 11–28–16; 8:45 am] information, and location will be posted of results of federally-funded research
BILLING CODE 4164–01–P on the CFSAC Web site http:// and development. Foreign patent
www.hhs.gov/ash/advisory-committees/ applications are filed on selected
cfsac/meetings/index.html. inventions to extend market coverage
DEPARTMENT OF HEALTH AND Thirty minutes will be allotted for for companies and may also be available
HUMAN SERVICES public comment via telephone or in for licensing and/or co-development.
person on each day of the meeting. Each ADDRESSES: Invention Development and
Meeting of the Chronic Fatigue individual will have three minutes to Marketing Unit, Technology Transfer
Syndrome Advisory Committee present their comments. Priority will be Center, National Cancer Institute, 9609
AGENCY: Office of the Assistant given to individuals who have not Medical Center Drive, Mail Stop 9702,
Secretary for Health, Department of provided public comment within the Rockville, MD 20850–9702.
Health and Human Services, Office of previous year. We are unable to place FOR FURTHER INFORMATION CONTACT:
the Secretary. international calls for public comments. Information on licensing and co-
ACTION: Notice. Individuals are required to register to development research collaborations,
participate in the public comment and copies of the U.S. patent
SUMMARY: As required by the Federal sessions. To request a time slot for applications listed below may be
Advisory Committee Act, the U.S. public comment, please send an email obtained by contacting: Attn. Invention
Department of Health and Human to cfsac@hhs.gov by January 5, 2017. Development and Marketing Unit,
Services is hereby giving notice that a The email should contain the speaker’s Technology Transfer Center, National
meeting of the Chronic Fatigue name and the telephone number at Cancer Institute, 9609 Medical Center
Syndrome Advisory Committee which the speaker can be reached for Drive, Mail Stop 9702, Rockville, MD
(CFSAC) will take place. This meeting the public comment session. 20850–9702, Tel. 240–276–5515 or
will be open to the public. Individuals who would like for their email ncitechtransfer@mail.nih.gov. A
DATES: Thursday, January 12, 2017, from testimony to be provided to the signed Confidential Disclosure
12:00 p.m. to 5:00 p.m. ET, and Friday, Committee members should submit a Agreement may be required to receive
January 13, 2017, from 9:00 a.m. to 5:00 copy of the testimony prior to the copies of the patent applications.
p.m. ET. meeting. It is preferred, but not SUPPLEMENTARY INFORMATION:
ADDRESSES: Individuals may attend this required, that the submitted testimony Technology description follows.
meeting in person and/or by utilizing be prepared in digital format and typed Title of invention: Genetically
virtual technology. Information for in- using a 12-pitch font. Copies of the Engineered Mouse-Derived Allograft for
person attendance will be posted on the written comment must not exceed 5 Use in Preclinical Studies of Metastatic
CFSAC Web site, http://www.hhs.gov/ single-space pages, and it is preferred, Melanoma Therapies.
ash/advisory-committees/cfsac/ but not required that the document be Keywords: Melanoma, GDA, Allograft,
meetings/index.html. Registration is prepared in the MS Word format. Please Genetically Engineered Mouse,
required for in-person attendance. note that PDF files, charts, and immunological response.
Information on the procedure to follow photographs cannot be accepted. Description of Technology: The
for registration will be included on the Materials submitted should not include invention listed below is owned by an
CFSAC Web site. For individuals sensitive personal information, such as agency of the U.S. Government and is
wishing to attend the meeting virtually, Social Security number, birthdate, available for licensing and/or co-
a webinar will be offered. Information driver’s license number, passport development in the U.S. in accordance
about accessing the webinar will be number, financial account number, or with 35 U.S.C. 209 and 37 CFR part 404
included on the CFSAC Web site. credit or debit card number. If you wish to achieve expeditious
commercialization of results of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: to remain anonymous, then document
Gustavo Seinos, MPH, Designated must specify this. federally-funded research and
Federal Officer, Chronic Fatigue The Committee welcomes input on development.
Syndrome Advisory Committee, any topic related to ME/CFS. Before testing drugs in humans, drug
Department of Health and Human developers are required to demonstrate
Services, 200 Independence Avenue Gustavo Seinos, a reasonable expectation of safety and
SW., Room 712E, Washington, DC Designated Federal Officer, CDR, USPHS. efficacy by performing so-called pre-
20201. Please direct all inquiries to [FR Doc. 2016–28723 Filed 11–28–16; 8:45 am] clinical studies. A key element of such
cfsac@hhs.gov. BILLING CODE 4150–42–P trials is the use of animal models,
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Document Created: 2016-11-29 00:32:42
Document Modified: 2016-11-29 00:32:42
| 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 public meeting; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on March 15, 2017, from 7:30 a.m. to 3:45 p.m. | |
| Contact | Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301- 796-9001, FAX: 301-847-8533, [email protected], 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 85978 |
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