80 FR 10493 - Pediatric Stakeholder Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 38 (February 26, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 38 (February 26, 2015)
| Page Range | 10493-10494 | |
| FR Document | 2015-03974 |
[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)] [Notices] [Pages 10493-10494] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03974] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-20115-N-0456] Pediatric Stakeholder 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) 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 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 March 25, 2015, from 9 a.m. to 5 p.m. Registration to attend the meeting should be received by March 20, 2015 (see the SUPPLEMENTARY INFORMATION section for instructions). ADDRESSES: The meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (1503-B & C), 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740. Submit either electronic or written comments by April 24, 2015. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FDA will post the agenda approximately 5 days before the meeting at: http://wwww.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm433552.htm. FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, terrie.crescenzi@fda.hhs.gov or Betsy 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 must be submitted to Congress by July 9, 2016, and 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. The basic content of the report will include: An assessment of the effectiveness of BPCA (section 505A) and PREA (section 505B) in improving information about pediatric uses for approved drugs and biological products, including the number and type of labeling changes made since the enactment of FDASIA and the importance of such uses in the improvement of the health of children; various statistics related to both PREA and BPCA, including the Written Request referral process with the National Institutes of Health; an assessment of the timeliness and effectiveness of pediatric study plans; an assessment of studying biologics; efforts made to increase the number of studies conducted in the neonatal population; the number and importance of drugs and biologics studied in children with cancer and any recommendations for modification to the programs that would improve pediatric drug research and increase labeling of drugs and biologics; an assessment of the successes of and limitations to studying drugs for rare diseases; an assessment of the efforts to address the suggestions and options described in any prior report issued by the Comptroller General, Institute of Medicine, or the Secretary, and any stakeholder recommendations or modifications that would improve pediatric drug research and pediatric labeling of drugs and biological products. The specific topics to be discussed at the meeting will include, but not be limited to, pediatric labeling changes, waivers and deferrals, Written Requests, pediatric study plans, programmatic activities with the NIH Written Request referral process, activities concerning neonates, pediatric cancers and rare diseases, and transparency. II. Meeting Attendance and Participation If you wish to attend this meeting, visit http://stakeholderinput.eventbrite.com. Please register by March 20, 2015. 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. If you need special accommodations due to a disability, please contact Betsy 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. 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 April 24, 2015. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., [[Page 10494]] Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: As soon as a transcript is available, FDA will post it at http://wwww.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm433552.htm. Dated: February 20, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-03974 Filed 2-25-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices 10493
title04/0403.htm. 1061, Rockville, MD 20852. All children with cancer and any
Karl Koerper, comments should be identified with the recommendations for modification to
docket number found in brackets in the the programs that would improve
Reports Clearance Officer.
heading of this document. pediatric drug research and increase
[FR Doc. 2015–03924 Filed 2–25–15; 8:45 am]
FDA will post the agenda labeling of drugs and biologics; an
BILLING CODE 4184–73–P approximately 5 days before the meeting assessment of the successes of and
at: http://wwww.fda.gov/NewsEvents/ limitations to studying drugs for rare
MeetingsConferencesWorkshops/ diseases; an assessment of the efforts to
DEPARTMENT OF HEALTH AND ucm433552.htm. address the suggestions and options
HUMAN SERVICES described in any prior report issued by
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration Terrie L. Crescenzi, Office of Pediatric the Comptroller General, Institute of
Therapeutics, Food and Drug Medicine, or the Secretary, and any
[Docket No. FDA–20115–N–0456] stakeholder recommendations or
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002, modifications that would improve
Pediatric Stakeholder Meeting; pediatric drug research and pediatric
Request for Comments terrie.crescenzi@fda.hhs.gov or Betsy
Sanford, Office of Pediatric labeling of drugs and biological
AGENCY: Food and Drug Administration, Therapeutics, Food and Drug products.
HHS. The specific topics to be discussed at
Administration, 10903 New Hampshire
ACTION: Notice of public meeting; the meeting will include, but not be
Ave., Silver Spring, MD 20993–0002,
limited to, pediatric labeling changes,
request for comments. elizabeth.sanford@fda.hhs.gov. waivers and deferrals, Written Requests,
SUPPLEMENTARY INFORMATION: pediatric study plans, programmatic
SUMMARY: The Food and Drug
Administration’s (FDA) Office of I. Background activities with the NIH Written Request
Pediatric Therapeutics (OPT), the Center referral process, activities concerning
On July 9, 2012, the President signed neonates, pediatric cancers and rare
for Drug Evaluation and Research into law the Food and Drug
(CDER) and the Center for Biologics diseases, and transparency.
Administration Safety and Innovation
Evaluation and Research (CBER) are Act (FDASIA) (Pub. L. 112–144). II. Meeting Attendance and
announcing a public meeting seeking Section 508 of FDASIA directs the Participation
input from patient groups, consumer Secretary of HHS to submit a report to
groups, regulated industry, academia If you wish to attend this meeting,
Congress on the implementation of the visit http://
and other interested parties to obtain Best Pharmaceuticals for Children Act
any recommendations or information stakeholderinput.eventbrite.com. Please
(BPCA) and Pediatric Research Equity register by March 20, 2015. Those who
relevant to the report to Congress that Act (PREA). The first report must be
FDA is required to submit concerning are unable to attend the meeting in
submitted to Congress by July 9, 2016, person can register to view a live
pediatrics, as outlined in section 508 of and every 5 years thereafter. FDASIA
the Food and Drug Administration Webcast of the meeting. You will be
also requires FDA to obtain, at least 180 asked to indicate in your registration if
Safety and Innovation Act (FDASIA) days prior to submission of the report, you plan to attend in person or via the
(see the SUPPLEMENTARY INFORMATION stakeholder input from patient groups, Webcast. Your registration will also
section for additional background consumer groups, regulated industry, contain your complete contact
information). academia, and any other interested information, including name, title,
DATES: The public meeting will be held parties to obtain any recommendations affiliation, address, email address, and
on March 25, 2015, from 9 a.m. to 5 p.m. or information relevant to the report phone number. Seating will be limited
Registration to attend the meeting including suggestions for modifications so early registration is recommended.
should be received by March 20, 2015 that would improve pediatric drug Registration is free and will be on a first-
(see the SUPPLEMENTARY INFORMATION research and pediatric labeling of drugs come, first-served basis. Onsite
section for instructions). and biological products. registration on the day of the meeting
ADDRESSES: The meeting will be held at The basic content of the report will will be based on space availability. If
FDA’s White Oak Campus, 10903 New include: An assessment of the you need special accommodations due
Hampshire Ave., Building 31 effectiveness of BPCA (section 505A) to a disability, please contact Betsy
Conference Center, the Great Room and PREA (section 505B) in improving Sanford (see FOR FURTHER INFORMATION
(1503–B & C), Silver Spring, MD 20993– information about pediatric uses for CONTACT) at least 7 days in advance.
0002. Entrance for the public meeting approved drugs and biological products, Persons attending the meeting are
participants (non-FDA employees) is including the number and type of advised that FDA is not responsible for
through Building 1 where routine labeling changes made since the providing access to electrical outlets.
security check procedures will be enactment of FDASIA and the Persons interested in presenting
performed. For information on parking importance of such uses in the comments at the meeting will be asked
and security procedures, please refer to improvement of the health of children; to indicate this in their registration.
http://www.fda.gov/AboutFDA/ various statistics related to both PREA FDA will try to accommodate all
WorkingatFDA/BuildingsandFacilities/ and BPCA, including the Written participant requests to speak, however
WhiteOakCampusInformation/ Request referral process with the the duration of comments may be
ucm241740. National Institutes of Health; an limited by time constraints.
rmajette on DSK2VPTVN1PROD with NOTICES
Submit either electronic or written assessment of the timeliness and Comments: Regardless of attendance
comments by April 24, 2015. Submit effectiveness of pediatric study plans; at the public meeting, you can submit
electronic comments to http:// an assessment of studying biologics; electronic or written comments to the
www.regulations.gov. Submit written efforts made to increase the number of public docket (see ADDRESSES) by April
comments to the Division of Dockets studies conducted in the neonatal 24, 2015. Received comments may be
Management (HFA–305), Food and Drug population; the number and importance seen in the Division of Dockets
Administration, 5630 Fishers Lane, Rm. of drugs and biologics studied in Management between 9 a.m. and 4 p.m.,
VerDate Sep<11>2014 15:27 Feb 25, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM 26FEN1](https://thefederalregister.org/doc/80_FR_10531/page/1.svg)
![10494 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices
Monday through Friday, and will be Agenda: The Committee will hear Room 17W65, Rockville, MD 20857;
posted to the docket at http:// presentations, including those on the telephone (301) 443–1127.
www.regulations.gov. following topics: Kidney Paired Jackie Painter,
Transcripts: As soon as a transcript is Donation; Vascularized Composite Director, Division of the Executive Secretariat.
available, FDA will post it at http:// Allografts; Donor Management
[FR Doc. 2015–03929 Filed 2–25–15; 8:45 am]
wwww.fda.gov/NewsEvents/ Research; Living Donation; and the
BILLING CODE 4165–15–P
MeetingsConferencesWorkshops/ Affordable Care Act and
ucm433552.htm. Transplantation. Agenda items are
Dated: February 20, 2015. subject to change as priorities indicate. DEPARTMENT OF HEALTH AND
Leslie Kux, After Committee discussions, HUMAN SERVICES
Associate Commissioner for Policy. members of the public will have an
[FR Doc. 2015–03974 Filed 2–25–15; 8:45 am] opportunity to comment. Because of the National Institutes of Health
BILLING CODE 4164–01–P Committee’s full agenda and timeframe Submission for OMB Review;
in which to cover the agenda topics, Emergency Clearance Request Human
public comment will be limited. All Influenza Surveillance of Health Care
DEPARTMENT OF HEALTH AND public comments will be included in Centers in the United States and
HUMAN SERVICES the record of the ACOT meeting. Taiwan
Meeting summary notes will be posted
Health Resources and Services SUMMARY: In accordance with Section
Administration on the Department’s organ donation
Web site at http://www.organdonor.gov/ 3507(j) of the Paperwork Reduction Act
of 1995, the National Institute of Allergy
Advisory Committee on Organ legislation/advisory.html#meetings.
and Infectious Diseases (NIAID), the
Transplantation; Notice of Meeting The draft meeting agenda will be National Institutes of Health (NIH), has
posted on www.blsmeetings.net/ACOT. submitted to the Office of Management
In accordance with section 10(a)(2) of Those participating on this meeting and Budget (OMB) a request for
the Federal Advisory Committee Act should pre-register by visiting emergency review and processing of this
(Pub. L. 92–463), notice is hereby given www.blsmeetings.net/ACOT. The information collection by March 7,
of the following meeting:
deadline to pre-register for this meeting 2015. NIAID is requesting emergency
Name: Advisory Committee on Organ processing of this information
is Wednesday, March 11, 2015.
Transplantation (ACOT). collection, pursuant to 5 CFR 1320.13,
Registration will be confirmed on site.
Date and Time: March 12, from 8:30 because NIAID cannot reasonably
For all logistical questions and
a.m. to 4:30 p.m. Eastern Standard comply with the normal clearance
concerns, please contact Anita Allen,
Time. March 13, from 8:30 a.m. to 12:30 procedures which would cause a delay
Seamon Corporation at 301–658–3442
p.m. Eastern Standard Time. and likely prevent or substantially
or send an email to aallen@
Place: Health Resources and Services disrupt the collection of information. A
Administration, 5600 Fishers Lane, seamoncorporation.com.
delay in starting the information
Room 05W11, Rockville, MD 20857. Public Comment: It is preferred that collection would hinder the agency in
Status: The meeting will be open to persons interested in providing an oral accomplishing its mission to the
the public. presentation email a written request, detriment of the public good. Public
Purpose: Under the authority of 42 along with a copy of their presentation, harm could result through the loss of
U.S.C. Section 217a, Section 222 of the to Patricia Stroup, MBA, MPA, critically needed information to
Public Health Service Act, as amended, Executive Secretary, Healthcare Systems understand the causes of severity of
and 42 CFR 121.12 (2000), ACOT was Bureau, Health Resources and Services influenza and associated morbidity and
established to assist the Secretary in Administration, at pstroup@hrsa.gov. mortality during the Northern
enhancing organ donation, ensuring that Requests should contain the name, hemisphere 2014–15 influenza season.
the system of organ transplantation is address, telephone number, email The National Institutes of Health may
grounded in the best available medical address, and any business or not conduct or sponsor, and the
science, and assuring the public that the professional affiliation of the person respondent is not required to respond
system is as effective and equitable as desiring to make an oral presentation. to, an information collection that has
possible, thereby increasing public Groups having similar interests are been extended, revised, or implemented
confidence in the integrity and requested to combine their comments on or after October 1, 1995, unless it
effectiveness of the transplantation and present them through a single displays a currently valid OMB control
system. ACOT is composed of up to 25 representative. number. Written comments and/or
members including the Chair. Members suggestions from the public and affected
serve as Special Government Employees The allocation of time may be agencies are invited on one or more of
and have diverse backgrounds in fields adjusted to accommodate the level of the following points: (1) Whether the
such as organ donation, health care expressed interest. Persons who do not proposed collection of information is
public policy, transplantation medicine file an advance request for a necessary for the proper performance of
and surgery, critical care medicine, and presentation, but desire to make an oral the function of the agency, including
other medical specialties involved in statement, may request it during the whether the information will have
the identification and referral of donors, public comment period. Public practical utility; (2) The accuracy of the
rmajette on DSK2VPTVN1PROD with NOTICES
non-physician transplant professions, participation and ability to comment agency’s estimate of the burden of the
nursing, epidemiology, immunology, will be limited to time as it permits. FOR proposed collection of information,
law and bioethics, behavioral sciences, FURTHER INFORMATION CONTACT: Patricia including the validity of the
economics and statistics, as well as Stroup, MBA, MPA, Executive methodology and assumptions used; (3)
representatives of transplant candidates, Secretary, Healthcare Systems Bureau, Ways to enhance the quality, utility, and
transplant recipients, organ donors, and Health Resources and Services clarity of the information to be
family members. Administration, 5600 Fishers Lane, collected; and (4) Ways to minimize the
VerDate Sep<11>2014 15:27 Feb 25, 2015 Jkt 235001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM 26FEN1](https://thefederalregister.org/doc/80_FR_10531/page/2.svg)
Document Created: 2015-12-18 13:05:32
Document Modified: 2015-12-18 13:05:32
| 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; request for comments. | |
| Dates | The public meeting will be held on March 25, 2015, from 9 a.m. to 5 p.m. Registration to attend the meeting should be received by March 20, 2015 (see the SUPPLEMENTARY INFORMATION section for instructions). | |
| Contact | Terrie L. Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, [email protected] or Betsy Sanford, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 10493 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR