Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 26061-26062 [2015-10482]

Download as PDF Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices Draft guidance Docket No. 40. Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves ........................ 41. Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection. 42. Use of Antibiotic Resistance Marker Genes in Transgenic Plants ............................................... 43. Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals. 44. Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act. 45. Guidance for Industry: Regulatory Procedures Manual—Chapter 9, Subchapter: Guidance Concerning Recommending Customs’ Seizure and Destruction of Imported Human and Animal Food That has Not Been Reconditioned; Draft Guidance. 46. Submission of Laboratory Packages By Accredited Laboratories ................................................ 47. Guidance for the Public and FDA Staff on Convening Advisory Committee Meetings ................ Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10477 Filed 5–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1376] Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.’’ This draft guidance is being issued to explain the circumstances in which it may be appropriate to leverage existing clinical data to support pediatric device indications in premarket approval applications (PMAs) and humanitarian device exemptions (HDEs). The draft guidance also describes the approach that FDA would use to determine whether extrapolation is appropriate in medical devices, and the factors that would be considered within a statistical model for extrapolation. Extrapolation may be appropriate when the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients and the adult data are of high quality for borrowing. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:43 May 05, 2015 Jkt 235001 guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 4, 2015. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance 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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jacqueline Francis, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993–0002, 301–796–6405; or Stephen Ripley, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background Section 520(m)(6)(E)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j) defines pediatric device patients as persons aged 21 or younger at the time of their diagnosis or PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 26061 Publication date FDA–2011–D–0030 FDA–2011–D–0102 2/7/2011 5/18/2011 FDA–1998–N–0050 FDA–2002–D–0135 9/4/1998 9/11/2002 FDA–2009–D–0563 11/27/2009 FDA–1998–N–0050 11/5/2002 FDA–2008–D–0510 FDA–2008–D–0417 1/2009 8/1/2008 treatment (i.e., from birth through the 21st year of life, up to but not including the 22d birthday). Pediatric subpopulations are defined in section 520(m)(6)(E)(ii) (and adopted by reference in section 515A(c) of the FD&C Act (21 U.S.C. 360e)) to be neonates, infants, children, and adolescents. In an attempt to promote pediatric medical device development, CDRH published a final guidance document in 2004 entitled ‘‘Premarket Assessment of Pediatric Medical Devices’’ (Ref. 1). This 2004 document indicates that data can be extrapolated to support effectiveness and, on a limited basis, safety for premarket approval applications (PMAs) when consistent with scientific principles. Congress was aware of this 2004 document when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of FDAAA is the Pediatric Medical Device Safety and Improvement Act (PMDSIA). The FDAAA specifically authorized the use of adult data to demonstrate pediatric effectiveness. While safety exploration is not discussed in PMDSIA, FDA believes that there are specific cases where it will be appropriate to consider extrapolation of existing clinical safety data to support or enhance evidence for pediatric indications. FDA seeks comment on the appropriateness of extrapolating from adult clinical data to support medical device safety in pediatric patients. FDA aims to increase the availability of safe and effective pediatric devices while ensuring that the approval of these devices is based on valid scientific evidence. Extrapolation of adult data for pediatric use may benefit pediatric patients by making it possible for devices to be approved for pediatricspecific indications and labeling, even when there is little or no existing pediatric data. Extrapolation facilitates the use of available relevant data by making optimal use of what is already known about device effects in other E:\FR\FM\06MYN1.SGM 06MYN1 26062 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices populations to support indications in the pediatric population. If extrapolation is found to be appropriate, FDA believes that statistical modeling and methods can be used to increase the precision of pediatric inferences. This guidance should be used in conjunction with other device-specific guidances to help ensure that medical devices intended for use in pediatric population provide reasonable assurance of safety and effectiveness. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on extrapolation of data for pediatric uses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. tkelley on DSK3SPTVN1PROD with NOTICES III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1827 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910–0485 (medical device labeling); the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078 (investigational device exemptions); the collections of information in 21 CFR part 814 have been approved under OMB control VerDate Sep<11>2014 18:43 May 05, 2015 Jkt 235001 number 0910–0231 (subparts A through E, premarket approval). V. Reference The following reference have been placed on display in the Division of Dockets Management (see ADDRESSES), and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at https:// www.regulations.gov. (FDA has verified the Web site address, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. FDA guidance entitled ‘‘Premarket Assessment of Pediatric Medical Devices,’’ March 24, 2014, available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/ucm089740.htm. VI. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https:// www.regulations.gov. Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10482 Filed 5–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2002–D–0147 (formerly Docket No. 2002D–0449)] Administrative Applications and the Phased Review Process; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #132 entitled ‘‘Administrative Applications and the Phased Review Process.’’ This guidance defines the ‘‘phased review process’’ for reviewing application-level information during the investigational period of new animal SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 drug development, and an ‘‘administrative’’ new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV–6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance 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: Katherine Weld, Center for Veterinary Medicine (HFV–108), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0846, Katherine.Weld@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 6, 2002 (67 FR 67631), FDA published the notice of availability for a draft guidance entitled ‘‘The Administrative New Animal Drug Application Process’’ giving interested persons until January 21, 2003, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance was updated to clarify current processes and include information about generic new animal drugs. The guidance announced in this notice finalizes the draft guidance dated November 6, 2002. To be legally marketed, a new animal drug must be the subject of either an approved application under section 512(b) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b), a conditional approval under section 571 of the FD&C Act (21 U.S.C. 360ccc), or an index listing under section 572 of the FD&C Act (21 U.S.C. 360ccc–1). Sections 512(b)(1) and 512(n)(1) of the FD&C Act describes the information that must be submitted to FDA, specifically the Center for E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26061-26062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10482]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1376]

Leveraging Existing Clinical Data for Extrapolation to Pediatric
Uses of Medical Devices; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Leveraging Existing
Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.''
This draft guidance is being issued to explain the circumstances in
which it may be appropriate to leverage existing clinical data to
support pediatric device indications in premarket approval applications
(PMAs) and humanitarian device exemptions (HDEs). The draft guidance
also describes the approach that FDA would use to determine whether
extrapolation is appropriate in medical devices, and the factors that
would be considered within a statistical model for extrapolation.
Extrapolation may be appropriate when the course of the disease or
condition and the effects of the device are sufficiently similar in
adults and pediatric patients and the adult data are of high quality
for borrowing. This draft guidance is not final nor is it in effect at
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 4, 2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses
of Medical Devices'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health (CDRH),
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive
label to assist that office in processing your request.
Submit electronic comments on the draft guidance 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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jacqueline Francis, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-6405;
or Stephen Ripley, Center for Biologics Evaluation and Research (CBER),
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

Section 520(m)(6)(E)(i) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j) defines pediatric device patients as
persons aged 21 or younger at the time of their diagnosis or treatment
(i.e., from birth through the 21st year of life, up to but not
including the 22d birthday). Pediatric subpopulations are defined in
section 520(m)(6)(E)(ii) (and adopted by reference in section 515A(c)
of the FD&C Act (21 U.S.C. 360e)) to be neonates, infants, children,
and adolescents.
In an attempt to promote pediatric medical device development, CDRH
published a final guidance document in 2004 entitled ``Premarket
Assessment of Pediatric Medical Devices'' (Ref. 1). This 2004 document
indicates that data can be extrapolated to support effectiveness and,
on a limited basis, safety for premarket approval applications (PMAs)
when consistent with scientific principles. Congress was aware of this
2004 document when it passed the Food and Drug Administration
Amendments Act of 2007 (FDAAA). Title III of FDAAA is the Pediatric
Medical Device Safety and Improvement Act (PMDSIA). The FDAAA
specifically authorized the use of adult data to demonstrate pediatric
effectiveness. While safety exploration is not discussed in PMDSIA, FDA
believes that there are specific cases where it will be appropriate to
consider extrapolation of existing clinical safety data to support or
enhance evidence for pediatric indications. FDA seeks comment on the
appropriateness of extrapolating from adult clinical data to support
medical device safety in pediatric patients.
FDA aims to increase the availability of safe and effective
pediatric devices while ensuring that the approval of these devices is
based on valid scientific evidence. Extrapolation of adult data for
pediatric use may benefit pediatric patients by making it possible for
devices to be approved for pediatric-specific indications and labeling,
even when there is little or no existing pediatric data. Extrapolation
facilitates the use of available relevant data by making optimal use of
what is already known about device effects in other

[[Page 26062]]

populations to support indications in the pediatric population. If
extrapolation is found to be appropriate, FDA believes that statistical
modeling and methods can be used to increase the precision of pediatric
inferences.
This guidance should be used in conjunction with other device-
specific guidances to help ensure that medical devices intended for use
in pediatric population provide reasonable assurance of safety and
effectiveness.

II. Significance of Guidance

This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on
extrapolation of data for pediatric uses. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Leveraging Existing Clinical
Data for Extrapolation to Pediatric Uses of Medical Devices'' may send
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic
copy of the document. Please use the document number 1827 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485 (medical device labeling);
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078 (investigational device exemptions);
the collections of information in 21 CFR part 814 have been approved
under OMB control number 0910-0231 (subparts A through E, premarket
approval).

V. Reference

The following reference have been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at https://www.regulations.gov. (FDA has
verified the Web site address, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. FDA guidance entitled ``Premarket Assessment of Pediatric Medical
Devices,'' March 24, 2014, available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm.

VI. Comments

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https://www.regulations.gov.

Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10482 Filed 5-5-15; 8:45 am]
BILLING CODE 4164-01-P

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