Pediatric Medical Devices; Public Workshop; Reopening of Comment Period, 3781-3782 [2012-1443]

Download as PDF srobinson on DSK4SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On February 28, 2012, the committee will meet in open session to hear an overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. 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[FR Doc. 2012–1456 Filed 1–24–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 3781 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0754] Pediatric Medical Devices; Public Workshop; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. The Food and Drug Administration (FDA) is reopening until March 5, 2012, the comment period for the notice entitled ‘‘Pediatric Medical Devices; Public Workshop; Request for Comments’’ that appeared in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463). In the notice, FDA announced a public workshop to consider factors affecting the use of scientific research data to support pediatric medical device efficacy claims. This is part of an on-going effort to address the ways scientific research data can be used to support pediatric effectiveness claims for medical devices and pediatric device approvals or clearance; the scientific and regulatory limitations and issues of using existing scientific research data to support pediatric effectiveness claims and pediatric indication approvals for medical devices; and methods to overcome the pitfalls and data gaps, including statistical approaches and modeling. The agency is taking this action to allow interested persons additional time to submit comments on the use of scientific research data, including published scientific literature, to support and establish pediatric indications for medical devices. DATES: Submit either electronic or written comments by March 5, 2012. ADDRESSES: Submit electronic comments to https:// 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. FOR FURTHER INFORMATION CONTACT: Carol Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993–0002, (301) 796–3241, Carol.Krueger@fda.hhs.gov. SUMMARY: SUPPLEMENTARY INFORMATION: I. Background In 2007, Congress passed the Pediatric Medical Device Safety and Improvement Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\25JAN1.SGM 25JAN1 3782 Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices srobinson on DSK4SPTVN1PROD with NOTICES Act (the Act). The Act addresses pediatric device needs by providing financial incentives for development, production, approval and distribution of new devices for rare and unmet pediatric needs; allowing for a pediatric device approval pathway that permits extrapolation of adult effectiveness data to support a pediatric indication based on similar course of the disease or condition or a similar effect of the device; and providing grants to pediatric device consortia that provide technical support and assistance to pediatric device innovators. FDA held a public workshop on December 5, 2011, to support FDA’s efforts to define pathways for approving pediatric device indications by leveraging available scientific research data. An important, but not the only, focus was a discussion of how to determine when it is appropriate to use, and how to use, existing scientific research data to determine pediatric effectiveness based on a similar course of a disease or condition or a similar effect of a device on adults and similar extrapolation between pediatric subpopulations. The demand by health care professionals and consumers for safe and effective pediatric medical devices continues to steadily increase. Pediatric medical devices treat or diagnose diseases and conditions occurring from birth through the 21st year of life. Some devices are designed specifically for pediatric use, while others are adopted from specific adult device applications or produced for more general use. Designing pediatric medical devices can be challenging; children are often smaller and more active than adults; body structures and functions change throughout childhood, and children may be long-term device users— bringing new concerns about device longevity and long-term exposure to implanted materials. The current medical device market for children has a higher demand than supply. FDA is committed to supporting the development and availability of safe and effective pediatric medical devices. Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments on the topics discussed at the Public Workshop. II. Topics Discussed at the Public Workshop The public workshop discussed the following topic areas: VerDate Mar<15>2010 18:09 Jan 24, 2012 Jkt 226001 1. The use of existing scientific research data to support pediatric effectiveness claims for medical devices and pediatric device approvals or clearance, 2. The scientific and regulatory limitations and issues with the use of existing scientific research data, and 3. The methods to overcome the pitfalls and data gaps, including statistical approaches and modeling. III. Transcripts Please be advised that a transcript of the public workshop is available at https://www.regulations.gov at FDA docket number FDA–2011–N–0754. The transcript may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript is also available online at https://www.fda.gov/ MedicalDevices/NewsEvents/ WorkshopsConferences/ ucm278053.htm. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 19, 2012. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2012–1443 Filed 1–24–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 1129. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the Agency; (b) the accuracy of the Agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: The Health Professions Student Loan (HPSL) and Nursing Student Loan (NSL) Programs: Forms (OMB No. 0915–0044)— [Extension] The HPSL Program provides longterm, low-interest loans to students attending schools of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, and pharmacy. The NSL program provides long-term, lowinterest loans to students who attend eligible schools of nursing in programs leading to a diploma in nursing, or associate, baccalaureate, or graduate degrees in nursing. Participating HPSL and NSL schools are responsible for determining the eligibility of applicants, making loans, and collecting monies owed by borrowers on their outstanding loans. The Deferment Form (Deferment-HRSA Form 519) provides the schools with documentation of a borrower’s eligibility for deferment. The Annual Operating Report (AOR–HRSA Form 501) provides the Federal Government with information from participating schools (schools that are no longer granting loans but are required to report and maintain program records, student records, and repayment records until all student loans are repaid in full and all monies due to the Federal Government are returned) relating to HPSL and NSL program operations and financial activities. The annual estimate of burden is as follows: E:\FR\FM\25JAN1.SGM 25JAN1

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[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3781-3782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1443]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0754]


Pediatric Medical Devices; Public Workshop; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening until 
March 5, 2012, the comment period for the notice entitled ``Pediatric 
Medical Devices; Public Workshop; Request for Comments'' that appeared 
in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463). In 
the notice, FDA announced a public workshop to consider factors 
affecting the use of scientific research data to support pediatric 
medical device efficacy claims. This is part of an on-going effort to 
address the ways scientific research data can be used to support 
pediatric effectiveness claims for medical devices and pediatric device 
approvals or clearance; the scientific and regulatory limitations and 
issues of using existing scientific research data to support pediatric 
effectiveness claims and pediatric indication approvals for medical 
devices; and methods to overcome the pitfalls and data gaps, including 
statistical approaches and modeling. The agency is taking this action 
to allow interested persons additional time to submit comments on the 
use of scientific research data, including published scientific 
literature, to support and establish pediatric indications for medical 
devices.

DATES: Submit either electronic or written comments by March 5, 2012.

ADDRESSES: Submit electronic comments to https://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.

FOR FURTHER INFORMATION CONTACT: Carol Krueger, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993-0002, (301) 796-3241, 
Carol.Krueger@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2007, Congress passed the Pediatric Medical Device Safety and 
Improvement

[[Page 3782]]

Act (the Act). The Act addresses pediatric device needs by providing 
financial incentives for development, production, approval and 
distribution of new devices for rare and unmet pediatric needs; 
allowing for a pediatric device approval pathway that permits 
extrapolation of adult effectiveness data to support a pediatric 
indication based on similar course of the disease or condition or a 
similar effect of the device; and providing grants to pediatric device 
consortia that provide technical support and assistance to pediatric 
device innovators.
    FDA held a public workshop on December 5, 2011, to support FDA's 
efforts to define pathways for approving pediatric device indications 
by leveraging available scientific research data. An important, but not 
the only, focus was a discussion of how to determine when it is 
appropriate to use, and how to use, existing scientific research data 
to determine pediatric effectiveness based on a similar course of a 
disease or condition or a similar effect of a device on adults and 
similar extrapolation between pediatric subpopulations.
    The demand by health care professionals and consumers for safe and 
effective pediatric medical devices continues to steadily increase. 
Pediatric medical devices treat or diagnose diseases and conditions 
occurring from birth through the 21st year of life. Some devices are 
designed specifically for pediatric use, while others are adopted from 
specific adult device applications or produced for more general use.
    Designing pediatric medical devices can be challenging; children 
are often smaller and more active than adults; body structures and 
functions change throughout childhood, and children may be long-term 
device users--bringing new concerns about device longevity and long-
term exposure to implanted materials. The current medical device market 
for children has a higher demand than supply. FDA is committed to 
supporting the development and availability of safe and effective 
pediatric medical devices.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic or written comments on the topics 
discussed at the Public Workshop.

II. Topics Discussed at the Public Workshop

    The public workshop discussed the following topic areas:
    1. The use of existing scientific research data to support 
pediatric effectiveness claims for medical devices and pediatric device 
approvals or clearance,
    2. The scientific and regulatory limitations and issues with the 
use of existing scientific research data, and
    3. The methods to overcome the pitfalls and data gaps, including 
statistical approaches and modeling.

III. Transcripts

    Please be advised that a transcript of the public workshop is 
available at https://www.regulations.gov at FDA docket number FDA-2011-
N-0754. The transcript may be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. A transcript is also available online at 
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm278053.htm.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 19, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-1443 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P

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