81 FR 54099 - Allergenic Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 157 (August 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 157 (August 15, 2016)
| Page Range | 54099-54100 | |
| FR Document | 2016-19338 |
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)] [Notices] [Pages 54099-54100] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19338] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Allergenic Products 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 Allergenic Products Advisory Committee. 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 October 27, 2016, from 1 p.m. to 4:20 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. 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: Janie Kim or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301- 796-9016 or 240-402-8158, email: [email protected] or [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 [[Page 54100]] appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. For those unable to attend in person, the meeting will also be available via Web cast. The Web cast will be available at the following link: https://collaboration.fda.gov/apac1016/. SUPPLEMENTARY INFORMATION: Agenda: On October 27, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Immunobiochemistry of the Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. 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 October 27, 2016, from 1 p.m. to 3:30 p.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 13, 2016. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 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 4, 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 5, 2016. Closed Committee Deliberations: On October 27, 2016, the meeting will be closed from 3:35 p.m. to 4:20 p.m. to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. 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 Janie Kim 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: August 9, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016-19338 Filed 8-12-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices 54099
estimate it will take 5 hours to complete MD 20910. The hotel’s phone number is Dated: August 8, 2016.
Form FDA 3542. 301–589–0800. Jeremy Sharp,
We estimate there will be 241 FOR FURTHER INFORMATION CONTACT: Lori Deputy Commissioner for Policy, Planning,
instances (based on an average of 114 Benner and/or Jessica Barnes, Center for Legislation and Analysis.
NDAs filed and 127 NDA supplements Drug Evaluation and Research, Food [FR Doc. 2016–19336 Filed 8–12–16; 8:45 am]
filed per year) where an NDA holder and Drug Administration, 10903 New BILLING CODE 4164–01–P
would comply with the patent Hampshire Ave., Bldg. 22, Rm. 6221,
declaration requirements. We estimate, Silver Spring, MD 20993–0002, 301–
based on a proportional increase from 796–1300. DEPARTMENT OF HEALTH AND
the number of declarations for approved HUMAN SERVICES
NDAs, that there will be an annual total SUPPLEMENTARY INFORMATION: FDA is
of 819 such declarations (241 × 3.4 announcing a public workshop Food and Drug Administration
declarations per instance = 819). Based regarding anti-infective drug
[Docket No. FDA–2016–N–0001]
upon informal communications with development for neonates and young
industry and our experience with the infants. Discussions will focus on Allergenic Products Advisory
collection, we estimate it will take 20 challenges related to enrolling neonates Committee; Notice of Meeting
hours to complete Form FDA 3542a. and young infants in clinical trials,
strategies to assess central nervous AGENCY: Food and Drug Administration,
Dated: August 5, 2016. system (CNS) penetration of the drug, HHS.
Jeremy Sharp, including nonclinical and in vitro data, ACTION: Notice.
Deputy Commissioner for Policy, Planning, potential development pathways, and
Legislation, and Analysis. the role of clinical trial networks in anti- SUMMARY: The Food and Drug
[FR Doc. 2016–19385 Filed 8–12–16; 8:45 am] infective drug development in the Administration (FDA) announces a
BILLING CODE 4164–01–P neonatal population. forthcoming public advisory committee
Registration: Registration is free for meeting of the Allergenic Products
the public workshop. Interested parties Advisory Committee. The general
DEPARTMENT OF HEALTH AND are encouraged to register early. Seating function of the committee is to provide
HUMAN SERVICES will be available on a first-come, first- advice and recommendations to the
served basis. To register electronically, Agency on FDA’s regulatory issues. At
Food and Drug Administration least one portion of the meeting will be
email registration information
(including name, title, firm name, closed to the public.
[Docket No. FDA–2016–N–0001] address, telephone, and fax number) to DATES: The meeting will be held on
NeonatalAntibacterialWorkshop2016@ October 27, 2016, from 1 p.m. to 4:20
Facilitating Anti-Infective Drug p.m.
fda.hhs.gov. Persons without access to
Development for Neonates and Young
the Internet can call 301–796–1300 to ADDRESSES: FDA White Oak Campus,
Infants; Notice of Public Workshop
register. 10903 New Hampshire Ave., Building
AGENCY: Food and Drug Administration, If you need special accommodations 31 Conference Center, the Great Room
HHS. due to a disability, please contact Jessica (Rm. 1503), Silver Spring, MD 20993–
ACTION: Notice of public workshop. Barnes or Lori Benner (see FOR FURTHER 0002. Answers to commonly asked
INFORMATION CONTACT) at least 7 days in questions including information
SUMMARY: The Food and Drug advance. regarding special accommodations due
Administration (FDA) is announcing a Agenda: The workshop draft Agenda to a disability, visitor parking, and
public workshop regarding anti- will be made available at: http:// transportation may be accessed at:
infective drug development for neonates www.fda.gov/Drugs/NewsEvents/ http://www.fda.gov/
and young infants. FDA is interested in ucm507958.htm at least 2 days prior to AdvisoryCommittees/
discussing the scientific challenges the meeting. The Agency encourages AboutAdvisoryCommittees/
pertaining to development of anti- individuals, industry, health care ucm408555.htm.
infective products for neonates and professionals, researchers, public health FOR FURTHER INFORMATION CONTACT:
young infants. This public workshop is organizations and other interested Janie Kim or Denise Royster, Center for
intended to provide information for and persons to attend this public workshop. Biologics Evaluation and Research,
gain perspective from health care Transcripts: Please be advised that as Food and Drug Administration, 10903
providers, other U.S. Government soon as a transcript is available, it will New Hampshire Ave., Bldg. 71, Silver
Agencies, public health organizations, be accessible at http:// Spring, MD 20993–0002, 301–796–9016
academic experts, and industry on www.regulations.gov. It may be viewed or 240–402–8158, email: Janie.Kim@
various aspects of drug development for at the Division of Dockets Management fda.hhs.gov or Denise.Royster@
new and currently marketed anti- (HFA–305), Food and Drug fda.hhs.gov, or FDA Advisory
infective drugs for neonates and young Administration, 5630 Fishers Lane, Rm. Committee Information Line, 1–800–
infants. The input from this public 1061, Rockville, MD 20852. A transcript 741–8138 (301–443–0572 in the
workshop will also help in developing will also be available in either hardcopy Washington, DC area). A notice in the
topics for future discussion. or on CD–ROM, after submission of a Federal Register about last minute
DATES: The public workshop will be Freedom of Information request. The modifications that impact a previously
sradovich on DSK3GMQ082PROD with NOTICES
held on September 15, 2016, from 8:30 Freedom of Information office address is announced advisory committee meeting
a.m. to 4:30 p.m. See the available on the Agency’s Web site at cannot always be published quickly
SUPPLEMENTARY INFORMATION section for http://www.fda.gov. Transcripts will enough to provide timely notice.
registration information. also be available on the Internet at: Therefore, you should always check the
ADDRESSES: The public workshop will http://www.fda.gov/Drugs/NewsEvents/ Agency’s Web site at http://
be held at the Sheraton Silver Spring ucm507958.htm approximately 45 days www.fda.gov/AdvisoryCommittees/
Hotel, 8777 Georgia Ave., Silver Spring, after the workshop. default.htm and scroll down to the
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![54100 Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
appropriate advisory committee meeting Closed Committee Deliberations: On DATES: Submit either electronic or
link, or call the advisory committee October 27, 2016, the meeting will be written comments on this guidance at
information line to learn about possible closed from 3:35 p.m. to 4:20 p.m. to any time. General comments on Agency
modifications before coming to the permit discussion where disclosure guidance documents are welcome at any
meeting. For those unable to attend in would constitute a clearly unwarranted time.
person, the meeting will also be invasion of personal privacy (5 U.S.C. ADDRESSES: You may submit comments
available via Web cast. The Web cast 552b(c)(6)). The committee will discuss as follows:
will be available at the following link: reports of intramural research programs
and make recommendations regarding Electronic Submissions
https://collaboration.fda.gov/apac1016/.
personnel staffing decisions. Submit electronic comments in the
SUPPLEMENTARY INFORMATION: Agenda: Persons attending FDA’s advisory following way:
On October 27, 2016, the committee will committee meetings are advised that the • Federal eRulemaking Portal: http://
meet by teleconference. In open session, Agency is not responsible for providing www.regulations.gov. Follow the
the committee will hear updates of access to electrical outlets. instructions for submitting comments.
research programs in the Laboratory of FDA welcomes the attendance of the Comments submitted electronically,
Immunobiochemistry of the Division of public at its advisory committee including attachments, to http://
Bacterial, Parasitic and Allergenic meetings and will make every effort to www.regulations.gov will be posted to
Products (DBPAP), Office of Vaccines accommodate persons with disabilities. the docket unchanged. Because your
Research and Review, Center for If you require accommodations due to a comment will be made public, you are
Biologics Evaluation and Research, disability, please contact Janie Kim at solely responsible for ensuring that your
FDA. least 7 days in advance of the meeting. comment does not include any
FDA intends to make background FDA is committed to the orderly confidential information that you or a
material available to the public no later conduct of its advisory committee third party may not wish to be posted,
than 2 business days before the meeting. meetings. Please visit our Web site at such as medical information, your or
If FDA is unable to post the background http://www.fda.gov/ anyone else’s Social Security number, or
material on its Web site prior to the AdvisoryCommittees/ confidential business information, such
meeting, the background material will AboutAdvisoryCommittees/ as a manufacturing process. Please note
be made publicly available at the ucm111462.htm for procedures on that if you include your name, contact
location of the advisory committee public conduct during advisory information, or other information that
meeting, and the background material committee meetings. identifies you in the body of your
will be posted on FDA’s Web site after Notice of this meeting is given under comments, that information will be
the meeting. Background material is the Federal Advisory Committee Act (5 posted on http://www.regulations.gov.
available at http://www.fda.gov/ U.S.C. app. 2). • If you want to submit a comment
AdvisoryCommittees/Calendar/ Dated: August 9, 2016. with confidential information that you
default.htm. Scroll down to the Janice M. Soreth, do not wish to be made available to the
appropriate advisory committee meeting Acting Associate Commissioner, Special
public, submit the comment as a
link. Medical Programs. written/paper submission and in the
[FR Doc. 2016–19338 Filed 8–12–16; 8:45 am]
manner detailed (see ‘‘Written/Paper
Procedure: On October 27, 2016, from Submissions’’ and ‘‘Instructions’’).
1 p.m. to 3:30 p.m., the meeting is open BILLING CODE 4164–01–P
to the public. Interested persons may Written/Paper Submissions
present data, information, or views, Submit written/paper submissions as
orally or in writing, on issues pending DEPARTMENT OF HEALTH AND
follows:
before the committee. Written HUMAN SERVICES • Mail/Hand delivery/Courier (for
submissions may be made to the contact written/paper submissions): Division of
Food and Drug Administration
person on or before October 13, 2016. Dockets Management (HFA–305), Food
Oral presentations from the public will [Docket No. FDA–2014–D–0217] and Drug Administration, 5630 Fishers
be scheduled between approximately Lane, Rm. 1061, Rockville, MD 20852.
2:30 p.m. and 3:30 p.m. Those Premarket Notification Submissions • For written/paper comments
individuals interested in making formal for Electrosurgical Devices for General submitted to the Division of Dockets
oral presentations should notify the Surgery; Guidance for Industry and Management, FDA will post your
contact person and submit a brief Food and Drug Administration Staff; comment, as well as any attachments,
statement of the general nature of the Availability except for information submitted,
evidence or arguments they wish to AGENCY: Food and Drug Administration, marked and identified, as confidential,
present, the names and addresses of HHS. if submitted as detailed in
proposed participants, and an ACTION: Notice of availability. ‘‘Instructions.’’
indication of the approximate time Instructions: All submissions received
requested to make their presentation on SUMMARY: The Food and Drug must include the Docket No. FDA–
or before October 4, 2016. Time allotted Administration (FDA or Agency) is 2014–D–0217 for ‘‘Premarket
for each presentation may be limited. If announcing the availability of the Notification (510(k)) Submissions for
the number of registrants requesting to guidance entitled ‘‘Premarket Electrosurgical Devices for General
speak is greater than can be reasonably Notification (510(k)) Submissions for Surgery.’’ Received comments will be
sradovich on DSK3GMQ082PROD with NOTICES
accommodated during the scheduled Electrosurgical Devices for General placed in the docket and, except for
open public hearing session, FDA may Surgery.’’ FDA has developed this those submitted as ‘‘Confidential
conduct a lottery to determine the guidance document to assist industry in Submissions,’’ publicly viewable at
speakers for the scheduled open public preparing premarket notification http://www.regulations.gov or at the
hearing session. The contact person will (510(k)) submissions for electrosurgical Division of Dockets Management
notify interested persons regarding their devices intended for use in general between 9 a.m. and 4 p.m., Monday
request to speak by October 5, 2016. surgery. through Friday.
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Document Created: 2016-08-13 02:22:18
Document Modified: 2016-08-13 02:22:18
| 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 October 27, 2016, from 1 p.m. to 4:20 p.m. | |
| Contact | Janie Kim or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 301- 796-9016 or 240-402-8158, email: [email protected] or [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. For those unable to attend in person, the meeting will also be available via Web cast. The Web cast will be available at the following link: https://collaboration.fda.gov/ apac1016/. | |
| FR Citation | 81 FR 54099 |
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