80 FR 33524 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 113 (June 12, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 113 (June 12, 2015)
| Page Range | 33524-33525 | |
| FR Document | 2015-14358 |
[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)] [Notices] [Pages 33524-33525] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. 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
![33524 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of Total annual
Collection Activity—21 CFR Section disclosures burden per Total hours
respondents disclosures
per respondent disclosure
Notification to Recipients—810.15(a)–(c) ........................ 2 1 2 12 24
Notification to Recipients; Followup—810.15(d) .............. 2 1 2 4 8
Notification of Consignees by Recipients—810.15(e) ..... 10 1 10 1 10
Total .......................................................................... ........................ ............................ ........................ ........................ 42
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 8, 2015. collection of information to OMB for classification from class III to class II or
Leslie Kux, review and clearance. class I provide an alternative route to
Associate Commissioner for Policy. Reclassification Petitions for Medical market in lieu of premarket approval for
[FR Doc. 2015–14359 Filed 6–11–15; 8:45 am] Devices (OMB Control Number 0910– class III devices. If approved, petitions
BILLING CODE 4164–01–P 0138)—Extension requesting reclassification from class I
or II, to a different class, may increase
Under sections 513(e) and (f), 514(b), requirements.
DEPARTMENT OF HEALTH AND 515(b), and 520(l) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) In the Federal Register of March 10,
HUMAN SERVICES
(21 U.S.C. 360c(e) and (f), 360d(b), 2015 (80 FR 12642), FDA published a
Food and Drug Administration 360e(b), and 360j(l)) and part 860 (21 60-day notice requesting public
CFR part 860), subpart C, FDA has comment on the proposed collection of
[Docket No. FDA–2011–N–0776] information. One comment was
responsibility to collect data and
Agency Information Collection information contained in received.
Activities; Submission for Office of reclassification petitions. The The comment refers to changes to the
Management and Budget Review; reclassification provisions of the FD&C form FDA 3429 as proposed by the
Comment Request; Reclassification Act allow any person to petition for commenter in a citizen petition (FDA–
Petitions for Medical Devices reclassification of a device from any of 2014–P–0283–0001), which was
the three classes, i.e., I, II, and III, to subsequently denied by FDA in a final
AGENCY: Food and Drug Administration, another class. The reclassification response letter to the petitioner (FDA–
HHS. content regulation (§ 860.123) requires 2014–P–0283–0003). Because the
ACTION: Notice. the submission of valid scientific proposed changes have already been
evidence demonstrating that the
SUMMARY: The Food and Drug denied through the citizen petition
proposed reclassification will provide a
Administration (FDA) is announcing process, we have not made changes to
reasonable assurance of safety and
that a proposed collection of effectiveness of the device type for its this information collection based on the
information has been submitted to the indications for use. comment.
Office of Management and Budget The reclassification procedure The Center for Devices and
(OMB) for review and clearance under regulation requires the submission of Radiological Health (CDRH) has
the Paperwork Reduction Act of 1995. specific data when a manufacturer is continually maintained contact with
DATES: Fax written comments on the petitioning for reclassification. This industry. Informal communications
collection of information by July 13, includes a ‘‘Supplemental Data Sheet,’’ concerning the importance and effect of
2015. Form FDA 3427, and a ‘‘General Device reclassification are provided primarily
ADDRESSES: To ensure that comments on Classification Questionnaire,’’ Form through trade organizations, and via
the information collection are received, FDA 3429. Both forms contain a series CDRH’s Web site. The consensus from
OMB recommends that written of questions concerning the safety and the Agency’s most recent contact with
comments be faxed to the Office of effectiveness of the device type. these trade organizations is that they are
Information and Regulatory Affairs, In the Federal Register of March 25, in favor of the program. The trade
OMB, Attn: FDA Desk Officer, FAX: 2014 (79 FR 16252), FDA issued a organizations involved are AdvaMed,
202–395–7285, or emailed to proposed rule that would eliminate the the Food and Drug Law Institute (FDLI),
oira_submission@omb.eop.gov. All need for Forms FDA 3427 and FDA and the National Electrical
comments should be identified with the 3429. However, because the proposed
Manufacturers Association (NEMA):
OMB control number 0910–0138. Also rule has not been finalized, we continue
to include the forms in the burden AdvaMed, Tara Federici, 1030 15th
include the FDA docket number found
in brackets in the heading of this estimate for this information collection. Street NW., suite 1100, Washington, DC
document. The reclassification provisions of the 20005, 202–452–8240;
FD&C Act serve primarily as a vehicle Food and Drug Law Institute (FDLI),
FOR FURTHER INFORMATION CONTACT: FDA for manufacturers to seek
PRA Staff, Office of Operations, Food 1000 Vermont Ave. NW., suite 1200,
mstockstill on DSK4VPTVN1PROD with NOTICES
reclassification from a higher to a lower Washington, DC 20005, 202–371–1420;
and Drug Administration, 8455 class, thereby reducing the regulatory
Colesville Rd., COLE–14526, Silver and National Electrical Manufacturers
requirements applicable to a particular Association (NEMA), 1300 North 17th
Spring, MD 20993–0002, device type, or to seek reclassification
PRAStaff@fda.hhs.gov. Street, suite 1847, Rosslyn, VA 22209,
from a lower to a higher class, thereby 703–841–3200.
SUPPLEMENTARY INFORMATION: In increasing the regulatory requirements
compliance with 44 U.S.C. 3507, FDA applicable to that device type. If FDA estimates the burden of this
has submitted the following proposed approved, petitions requesting collection of information as follows:
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![Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices 33525
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
FDA Form Number of Total annual
Activity responses per burden per Total hours
Nos. respondents responses
respondent 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 positioning chair with a motorized Drug Administration, 10903 New
received in the last 3 years, FDA positioning control that is intended for Hampshire Ave., Bldg. 66, Rm. 1524,
anticipates that six petitions will be medical purposes and that can be Silver Spring, MD 20993–0002, 301–
submitted each year. The time required adjusted to various positions. The 796–6424, jismi.johnson@fda.hhs.gov.
to prepare and submit a reclassification device is used to provide stability for SUPPLEMENTARY INFORMATION:
petition, including the time needed to patients with athetosis (involuntary
assemble supporting data, averages 500 spasms) and to alter postural positions. I. Statutory Background
hours per petition. This average is based FDA is publishing this notice to obtain Under section 513 of the Federal
upon estimates by FDA administrative comments in accordance with Food, Drug, and Cosmetic Act (the
and technical staff who: (1) Are familiar procedures established by the Food and FD&C Act) (21 U.S.C. 360c), FDA must
with the requirements for submission of Drug Administration Modernization Act classify devices into one of three
a reclassification petition, (2) have of 1997 (FDAMA). regulatory classes: Class I, class II, or
consulted and advised manufacturers on DATES: Submit either electronic or class III. FDA classification of a device
these requirements, and (3) have written comments by July 13, 2015. is determined by the amount of
reviewed the documentation submitted. ADDRESSES: You may submit comments, regulation necessary to provide a
This document refers to previously identified by Docket No. FDA–2015–P– reasonable assurance of safety and
approved collections of information 1197, by any of the following methods: effectiveness. Under the Medical Device
found in FDA regulations. These Amendments of 1976 (1976
collections of information are subject to Electronic Submissions amendments) (Pub. L. 94–295), as
review by the Office of Management and Submit electronic comments in the amended by the Safe Medical Devices
Budget (OMB) under the Paperwork following way: Act of 1990 (Pub. L. 101–629), devices
Reduction Act of 1995 (44 U.S.C. 3501– • Federal eRulemaking Portal: http:// are to be classified into class I (general
3520). The collections of information in www.regulations.gov. Follow the controls) if there is information showing
21 CFR part 807, subpart E, have been instructions for submitting comments. that the general controls of the FD&C
approved under OMB control number Act are sufficient to assure safety and
0910–0120 and the collections of Written Submissions effectiveness; into class II (special
information in 21 CFR part 814, Submit written submissions in the controls) if general controls, by
subparts A through E, have been following way: themselves, are insufficient to provide
approved under OMB control number • Mail/Hand delivery/Courier (for reasonable assurance of safety and
0910–0231. paper submissions): Division of Dockets effectiveness, but there is sufficient
Dated: June 8, 2015. Management (HFA–305), Food and Drug information to establish special controls
Administration, 5630 Fishers Lane, Rm. to provide such assurance; and into
Leslie Kux,
1061, Rockville, MD 20852. class III (premarket approval) if there is
Associate Commissioner for Policy. Instructions: All submissions received insufficient information to support
[FR Doc. 2015–14358 Filed 6–11–15; 8:45 am] must include the docket number for this classifying a device into class I or class
BILLING CODE 4164–01–P notice. All comments received may be II and the device is a life sustaining or
posted without change to http:// life supporting device, or is for a use
www.regulations.gov, including any which is of substantial importance in
DEPARTMENT OF HEALTH AND personal information provided. For preventing impairment of human health
HUMAN SERVICES additional information on submitting or presents a potential unreasonable risk
Food and Drug Administration comments, see the ‘‘Comments’’ heading of illness or injury.
of the SUPPLEMENTARY INFORMATION Most generic types of devices that
[Docket No. FDA–2015–P–1197] section of this document. were on the market before the date of
Docket: For access to the docket to the 1976 amendments (May 28, 1976)
Medical Devices; Exemption From read background documents or (generally referred to as preamendments
Premarket Notification: Electric comments received, go to http:// devices) have been classified by FDA
Positioning Chair www.regulations.gov and insert the under the procedures set forth in section
AGENCY: Food and Drug Administration, docket number, found in brackets in the 513(c) and (d) of the FD&C Act through
heading of this document, into the
mstockstill on DSK4VPTVN1PROD with NOTICES
HHS. the issuance of classification regulations
‘‘Search’’ box and follow the prompts, into one of these three regulatory
ACTION: Notice.
and/or go to the Division of Dockets classes. Devices introduced into
SUMMARY: The Food and Drug Management, 5630 Fishers Lane, Rm. interstate commerce for the first time on
Administration (FDA) is announcing 1061, Rockville, MD 20852. or after May 28, 1976 (generally referred
that it has received a petition requesting FOR FURTHER INFORMATION CONTACT: to as postamendments devices), are
exemption from the premarket Jismi Johnson, Center for Devices and classified through the premarket
notification requirements for an electric Radiological Health (CDRH), Food and notification process under section
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Document Created: 2018-02-22 10:16:33
Document Modified: 2018-02-22 10:16:33
| 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. | |
| Dates | Fax written comments on the collection of information by July 13, 2015. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 33524 |
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