Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices, 33524-33525 [2015-14358]

Download as PDF 33524 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Collection Activity—21 CFR Section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Notification to Recipients—810.15(a)–(c) ........................ Notification to Recipients; Followup—810.15(d) .............. Notification of Consignees by Recipients—810.15(e) ..... Total .......................................................................... 2 2 10 ........................ 1 1 1 ............................ 2 2 10 ........................ 12 4 1 ........................ 1 There collection of information to OMB for review and clearance. Reclassification Petitions for Medical Devices (OMB Control Number 0910– 0138)—Extension [FR Doc. 2015–14359 Filed 6–11–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0776] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 13, 2015. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0138. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: mstockstill on DSK4VPTVN1PROD with NOTICES 24 8 10 42 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 8, 2015. Leslie Kux, Associate Commissioner for Policy. AGENCY: Total hours In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 20:18 Jun 11, 2015 Jkt 235001 Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860), subpart C, FDA has responsibility to collect data and information contained in reclassification petitions. The reclassification provisions of the FD&C Act allow any person to petition for reclassification of a device from any of the three classes, i.e., I, II, and III, to another class. The reclassification content regulation (§ 860.123) requires the submission of valid scientific evidence demonstrating that the proposed reclassification will provide a reasonable assurance of safety and effectiveness of the device type for its indications for use. The reclassification procedure regulation requires the submission of specific data when a manufacturer is petitioning for reclassification. This includes a ‘‘Supplemental Data Sheet,’’ Form FDA 3427, and a ‘‘General Device Classification Questionnaire,’’ Form FDA 3429. Both forms contain a series of questions concerning the safety and effectiveness of the device type. In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued a proposed rule that would eliminate the need for Forms FDA 3427 and FDA 3429. However, because the proposed rule has not been finalized, we continue to include the forms in the burden estimate for this information collection. The reclassification provisions of the FD&C Act serve primarily as a vehicle for manufacturers to seek reclassification from a higher to a lower class, thereby reducing the regulatory requirements applicable to a particular device type, or to seek reclassification from a lower to a higher class, thereby increasing the regulatory requirements applicable to that device type. If approved, petitions requesting PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 classification from class III to class II or class I provide an alternative route to market in lieu of premarket approval for class III devices. If approved, petitions requesting reclassification from class I or II, to a different class, may increase requirements. In the Federal Register of March 10, 2015 (80 FR 12642), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received. The comment refers to changes to the form FDA 3429 as proposed by the commenter in a citizen petition (FDA– 2014–P–0283–0001), which was subsequently denied by FDA in a final response letter to the petitioner (FDA– 2014–P–0283–0003). Because the proposed changes have already been denied through the citizen petition process, we have not made changes to this information collection based on the comment. The Center for Devices and Radiological Health (CDRH) has continually maintained contact with industry. Informal communications concerning the importance and effect of reclassification are provided primarily through trade organizations, and via CDRH’s Web site. The consensus from the Agency’s most recent contact with these trade organizations is that they are in favor of the program. The trade organizations involved are AdvaMed, the Food and Drug Law Institute (FDLI), and the National Electrical Manufacturers Association (NEMA): AdvaMed, Tara Federici, 1030 15th Street NW., suite 1100, Washington, DC 20005, 202–452–8240; Food and Drug Law Institute (FDLI), 1000 Vermont Ave. NW., suite 1200, Washington, DC 20005, 202–371–1420; and National Electrical Manufacturers Association (NEMA), 1300 North 17th Street, suite 1847, Rosslyn, VA 22209, 703–841–3200. FDA estimates the burden of this collection of information as follows: E:\FR\FM\12JNN1.SGM 12JNN1 33525 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity FDA Form Nos. Number of respondents Number of responses per respondent Total annual responses Average burden per response Supporting data for reclassification petition ..... Supplemental Data Sheet ................................ General Device Classification Questionnaire .. Total ................................................................. .................... 3427 3429 .................... 6 6 6 ........................ 1 1 1 ........................ 6 6 6 ........................ 497 1.5 1.5 ........................ 1 There Dated: June 8, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14358 Filed 6–11–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–P–1197] mstockstill on DSK4VPTVN1PROD with NOTICES Medical Devices; Exemption From Premarket Notification: Electric Positioning Chair Food and Drug Administration, HHS. ACTION: 2,982 9 9 3,000 are no capital costs or operating and maintenance costs associated with this collection of information. Based on reclassification petitions received in the last 3 years, FDA anticipates that six petitions will be submitted each year. The time required to prepare and submit a reclassification petition, including the time needed to assemble supporting data, averages 500 hours per petition. This average is based upon estimates by FDA administrative and technical staff who: (1) Are familiar with the requirements for submission of a reclassification petition, (2) have consulted and advised manufacturers on these requirements, and (3) have reviewed the documentation submitted. This document 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 part 807, subpart E, have been approved under OMB control number 0910–0120 and the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910–0231. AGENCY: Total hours Notice. The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for an electric SUMMARY: VerDate Sep<11>2014 19:05 Jun 11, 2015 Jkt 235001 positioning chair with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). DATES: Submit either electronic or written comments by July 13, 2015. ADDRESSES: You may submit comments, identified by Docket No. FDA–2015–P– 1197, by any of the following methods: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following way: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the docket number for this notice. All comments received may be posted without change to https:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and Radiological Health (CDRH), Food and PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993–0002, 301– 796–6424, jismi.johnson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Statutory Background Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94–295), as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101–629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls) if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval) if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device, or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices), are classified through the premarket notification process under section E:\FR\FM\12JNN1.SGM 12JNN1

Agencies

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33524-33525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14358]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0776]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
13, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0138.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Reclassification Petitions for Medical Devices (OMB Control Number
0910-0138)--Extension

Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(e)
and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21 CFR part 860),
subpart C, FDA has responsibility to collect data and information
contained in reclassification petitions. The reclassification
provisions of the FD&C Act allow any person to petition for
reclassification of a device from any of the three classes, i.e., I,
II, and III, to another class. The reclassification content regulation
(Sec. 860.123) requires the submission of valid scientific evidence
demonstrating that the proposed reclassification will provide a
reasonable assurance of safety and effectiveness of the device type for
its indications for use.
The reclassification procedure regulation requires the submission
of specific data when a manufacturer is petitioning for
reclassification. This includes a ``Supplemental Data Sheet,'' Form FDA
3427, and a ``General Device Classification Questionnaire,'' Form FDA
3429. Both forms contain a series of questions concerning the safety
and effectiveness of the device type.
In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued
a proposed rule that would eliminate the need for Forms FDA 3427 and
FDA 3429. However, because the proposed rule has not been finalized, we
continue to include the forms in the burden estimate for this
information collection.
The reclassification provisions of the FD&C Act serve primarily as
a vehicle for manufacturers to seek reclassification from a higher to a
lower class, thereby reducing the regulatory requirements applicable to
a particular device type, or to seek reclassification from a lower to a
higher class, thereby increasing the regulatory requirements applicable
to that device type. If approved, petitions requesting classification
from class III to class II or class I provide an alternative route to
market in lieu of premarket approval for class III devices. If
approved, petitions requesting reclassification from class I or II, to
a different class, may increase requirements.
In the Federal Register of March 10, 2015 (80 FR 12642), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received.
The comment refers to changes to the form FDA 3429 as proposed by
the commenter in a citizen petition (FDA-2014-P-0283-0001), which was
subsequently denied by FDA in a final response letter to the petitioner
(FDA-2014-P-0283-0003). Because the proposed changes have already been
denied through the citizen petition process, we have not made changes
to this information collection based on the comment.
The Center for Devices and Radiological Health (CDRH) has
continually maintained contact with industry. Informal communications
concerning the importance and effect of reclassification are provided
primarily through trade organizations, and via CDRH's Web site. The
consensus from the Agency's most recent contact with these trade
organizations is that they are in favor of the program. The trade
organizations involved are AdvaMed, the Food and Drug Law Institute
(FDLI), and the National Electrical Manufacturers Association (NEMA):
AdvaMed, Tara Federici, 1030 15th Street NW., suite 1100,
Washington, DC 20005, 202-452-8240;
Food and Drug Law Institute (FDLI), 1000 Vermont Ave. NW., suite
1200, Washington, DC 20005, 202-371-1420; and National Electrical
Manufacturers Association (NEMA), 1300 North 17th Street, suite 1847,
Rosslyn, VA 22209, 703-841-3200.
FDA estimates the burden of this collection of information as
follows:

[[Page 33525]]

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity FDA Form Number of responses per Total annual burden per Total hours
Nos. respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting data for reclassification petition................. ........... 6 1 6 497 2,982
Supplemental Data Sheet....................................... 3427 6 1 6 1.5 9
General Device Classification Questionnaire................... 3429 6 1 6 1.5 9
Total......................................................... ........... .............. .............. .............. .............. 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on reclassification petitions received in the last 3 years,
FDA anticipates that six petitions will be submitted each year. The
time required to prepare and submit a reclassification petition,
including the time needed to assemble supporting data, averages 500
hours per petition. This average is based upon estimates by FDA
administrative and technical staff who: (1) Are familiar with the
requirements for submission of a reclassification petition, (2) have
consulted and advised manufacturers on these requirements, and (3) have
reviewed the documentation submitted.
This document 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 part 807, subpart E, have been
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR part 814, subparts A through E, have been
approved under OMB control number 0910-0231.

Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14358 Filed 6-11-15; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.