Pediatric Stakeholder Meeting; Public Meeting; Request for Comments, 57451-57452 [2019-23264]

Download as PDF Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices 57451 TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued OMB control No. Title of collection Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act ............................................................................................................... Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco ........................................................................................... Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of .......................................................................................................................................................... February 15, 2007 ................................................................................................................................................... Medicated Feed Mill License Application ................................................................................................................ Guidance on Informed Consent for In Vitro Diagnostic Studies Using Leftover Human Specimens That Are Not Individually Identifiable ......................................................................................................................................... Manufactured Food Regulatory Program Standards .............................................................................................. Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements ........................................................................................................................................... Generic Clearance for Quick Turnaround Testing of Communication Effectiveness ............................................. Dated: October 17, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–23251 Filed 10–24–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4560] Pediatric Stakeholder Meeting; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration’s (FDA or the Agency) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient/parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information). DATES: The public meeting will be held on November 21, 2019, from 9 a.m. to 3 p.m. Registration to attend the meeting should be received by November 15, 2019. Onsite registration on the day of the meeting will be based on space availability. Submit either electronic or written comments on the public meeting by December 19, 2019. See the SUMMARY: VerDate Sep<11>2014 18:04 Oct 24, 2019 Jkt 250001 SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (1503–A), Silver Spring, MD 20993– 0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For information on parking and security procedures, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 19, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 manufacturing process. Please note that if you include your name, contact PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Date approval expires 0910–0732 8/31/2022 0910–0749 8/31/2022 0910–0775 0910–0337 8/31/2022 9/30/2022 0910–0582 0910–0601 9/30/2022 9/30/2022 0910–0661 0910–0876 9/30/2022 9/30/2022 information, or other information that identifies you in the body of your comments, that information will be posted on https://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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2019–N–4560 for ‘‘Pediatric Stakeholder Meeting.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docker and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 E:\FR\FM\25OCN1.SGM 25OCN1 57452 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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 CR 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Terrie Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, terrie.crescenzi@fda.hhs.gov or Elizabeth Sanford, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, elizabeth.sanford@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub L. 112–144). Section 508 of FDASIA directs the Secretary of HHS to submit a report to Congress on the implementation of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA). The first report was required to be submitted to Congress by July 9, 2016, and subsequent reports are required every 5 years thereafter. FDASIA also requires FDA to obtain, at least 180 days prior to submission of the report, stakeholder input from patient groups, consumer groups, regulated VerDate Sep<11>2014 18:04 Oct 24, 2019 Jkt 250001 industry, academia, and any other interested parties to obtain any recommendations or information relevant to the report including suggestions for modifications that would improve pediatric drug research and pediatric labeling of drugs and biological products. In addition, on August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) (Pub L. 115–52) was signed into law, which outlined additional requirements to be included in the report. Some of the issues to be discussed at the meeting will include, but not be limited to: • Hearing from patients/parents and patient/parent groups, industry, academia and other stakeholders about the public health impact that pediatric legislation may have had on them or their communities; • Understanding the effects of the requirement of pediatric studies under PREA or the incentives under BPCA on drug/biologic development plans; and • Understanding if there are any barriers or resource issues preventing undertaking or completing studies under PREA and BPCA. II. Meeting Attendance and Participation If you wish to attend this meeting, visit https://www.eventbrite.com/e/ stakeholder-input-on-pediatriclegislation-registration-74306461627. Please register by November 15, 2019. Those who are unable to attend the meeting in person can register to view a live webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Your registration will also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. Seating will be limited so early registration is recommended. Registration is free and will be on a firstcome, first-served basis. Onsite registration on the day of the meeting will be based on space availability. To view the webcast, visit: https:// collaboration.fda.gov/pediatric legislation/. If you need special accommodations due to a disability, please contact Elizabeth Sanford (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Persons attending the meeting are advised that FDA is not responsible for providing access to electrical outlets. Persons interested in presenting comments at the meeting will be asked to indicate this in their registration. If you intend to use a PowerPoint presentation, please email the PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 presentation to opt@fda.hhs.gov by November 15, 2019. FDA will try to accommodate all participant requests to speak, however the duration of comments may be limited by time constraints. Comments: Regardless of attendance at the public meeting, you can submit electronic or written comments to the public docket (see ADDRESSES) by December 19, 2019. Received comments may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: October 21, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–23264 Filed 10–24–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0283] Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.’’ This draft guidance revises the guidance for industry of the same name issued April 1, 2011. The draft guidance is being revised to describe the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes. The draft guidance is also being revised to reflect certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act as they relate to postmarketing studies and clinical trials. SUMMARY: E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57451-57452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23264]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4560]


Pediatric Stakeholder Meeting; Public Meeting; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA or the Agency) Office 
of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and 
Research (CDER) and the Center for Biologics Evaluation and Research 
(CBER) are announcing a public meeting seeking input from patient/
parent groups, consumer groups, regulated industry, academia, and other 
interested parties to obtain any recommendations or information 
relevant to the report to Congress that FDA is required to submit 
concerning pediatrics, as outlined in section 508 of the Food and Drug 
Administration Safety and Innovation Act (FDASIA) (see the 
SUPPLEMENTARY INFORMATION section for additional background 
information).

DATES: The public meeting will be held on November 21, 2019, from 9 
a.m. to 3 p.m. Registration to attend the meeting should be received by 
November 15, 2019. Onsite registration on the day of the meeting will 
be based on space availability. Submit either electronic or written 
comments on the public meeting by December 19, 2019. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(1503-A), Silver Spring, MD 20993-0002. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1, where routine 
security check procedures will be performed. For information on parking 
and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before December 19, 2019. Comments received by mail/
hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2019-N-4560 for ``Pediatric Stakeholder Meeting.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docker and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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

[[Page 57452]]

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 https://www.regulations.gov. Submit both copies to the Dockets 
Management Staff. 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 CR 
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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Terrie Crescenzi, Office of Pediatric 
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, [email protected] or Elizabeth 
Sanford, Office of Pediatric Therapeutics, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug 
Administration Safety and Innovation Act (FDASIA) (Pub L. 112-144). 
Section 508 of FDASIA directs the Secretary of HHS to submit a report 
to Congress on the implementation of the Best Pharmaceuticals for 
Children Act (BPCA) and Pediatric Research Equity Act (PREA). The first 
report was required to be submitted to Congress by July 9, 2016, and 
subsequent reports are required every 5 years thereafter. FDASIA also 
requires FDA to obtain, at least 180 days prior to submission of the 
report, stakeholder input from patient groups, consumer groups, 
regulated industry, academia, and any other interested parties to 
obtain any recommendations or information relevant to the report 
including suggestions for modifications that would improve pediatric 
drug research and pediatric labeling of drugs and biological products. 
In addition, on August 18, 2017, the Food and Drug Administration 
Reauthorization Act (FDARA) (Pub L. 115-52) was signed into law, which 
outlined additional requirements to be included in the report.
    Some of the issues to be discussed at the meeting will include, but 
not be limited to:
     Hearing from patients/parents and patient/parent groups, 
industry, academia and other stakeholders about the public health 
impact that pediatric legislation may have had on them or their 
communities;
     Understanding the effects of the requirement of pediatric 
studies under PREA or the incentives under BPCA on drug/biologic 
development plans; and
     Understanding if there are any barriers or resource issues 
preventing undertaking or completing studies under PREA and BPCA.

II. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://www.eventbrite.com/e/stakeholder-input-on-pediatric-legislation-registration-74306461627. Please register by November 15, 2019. Those 
who are unable to attend the meeting in person can register to view a 
live webcast of the meeting. You will be asked to indicate in your 
registration if you plan to attend in person or via the webcast. Your 
registration will also contain your complete contact information, 
including name, title, affiliation, address, email address, and phone 
number. Seating will be limited so early registration is recommended. 
Registration is free and will be on a first-come, first-served basis. 
Onsite registration on the day of the meeting will be based on space 
availability. To view the webcast, visit: https://collaboration.fda.gov/pediatriclegislation/. If you need special 
accommodations due to a disability, please contact Elizabeth Sanford 
(see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. 
Persons attending the meeting are advised that FDA is not responsible 
for providing access to electrical outlets.
    Persons interested in presenting comments at the meeting will be 
asked to indicate this in their registration. If you intend to use a 
PowerPoint presentation, please email the presentation to 
[email protected] by November 15, 2019. FDA will try to accommodate all 
participant requests to speak, however the duration of comments may be 
limited by time constraints.
    Comments: Regardless of attendance at the public meeting, you can 
submit electronic or written comments to the public docket (see 
ADDRESSES) by December 19, 2019. Received comments may be seen in the 
Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, and will be posted to the docket at https://www.regulations.gov.

    Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23264 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P

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