83 FR 9743 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 45 (March 7, 2018)

Page Range		9743-9745
FR Document		2018-04613

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection related to Reclassification Petitions for Medical Devices.

Federal Register, Volume 83 Issue 45 (Wednesday, March 7, 2018)

[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Notices]
[Pages 9743-9745]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reclassification Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection related to 
Reclassification Petitions for Medical Devices.

DATES: Submit either electronic or written comments on the collection 
of information by May 7, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 7, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of May 7, 2018. Comments received by 
mail/hand delivery/courier

[[Page 9744]]

(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0776 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Reclassification Petitions for 
Medical Devices.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Reclassification Petitions for Medical Devices--21 CFR Section 860.123

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 (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 the 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

[[Page 9745]]

proposed rule that would eliminate the need for Forms FDA 3427 and 
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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
                 Activity/21 CFR section                   FDA form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting data for reclassification petition--21 CFR     ..............               6               1               6             497           2,982
 860.123................................................
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.
    The burden estimate for this information collection has not changed 
since the last OMB approval.

    Dated: February 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04613 Filed 3-6-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Notices 9743

Total Annual Cost: No cost. also will be available for inspection at indicated or the offices of the Board of
Nature and Extent of Confidentiality: the offices of the Board of Governors. Governors not later than April 2, 2018.
An assurance of confidentiality is not Interested persons may express their A. Federal Reserve Bank of St. Louis
offered because this information views in writing to the Reserve Bank (David L. Hubbard, Senior Manager)
collection does not require the indicated for that notice or to the offices P.O. Box 442, St. Louis, Missouri
collection of personally identifiable of the Board of Governors. Comments 63166–2034. Comments can also be sent
information from individuals. must be received not later than March electronically to
Privacy Impact Assessment: No 20, 2018. Comments.applications@stls.frb.org:
impact(s). A. Federal Reserve Bank of Atlanta 1. Stark Bancshares, Inc., Canton,
Needs and Uses: The Commission (Kathryn Haney, Director of Ohio; to become a bank holding
amended rules requiring that carriers Applications) 1000 Peachtree Street NE, company by acquiring 100 percent of
honor privacy requests to state that Atlanta, Georgia 30309. Comments can the voting shares of Farmers Financial
§ 64.1601(b) of the Commission’s rules also be sent electronically to Corporation, Bolivar, Missouri, and
shall not apply when calling party Applications.Comments@atl.frb.org: thereby indirectly acquire Farmers State
number (CPN) delivery is made in 1. Delmar Allan Benton, Madisonville, Bank, SB, Schell City, Missouri.
connection with a threatening call. Tennessee; to retain voting shares of Board of Governors of the Federal Reserve
Upon report of such a threatening call Peoples Bancshares of Tennessee Inc., System, March 1, 2018.
by law enforcement on behalf of the and thereby indirectly retain shares of Ann E. Misback,
threatened party, the carrier will Peoples Bank of East Tennessee, both of Secretary of the Board.
provide any CPN of the calling party to Madisonville, Tennessee. [FR Doc. 2018–04591 Filed 3–6–18; 8:45 am]
law enforcement and, as directed by law
Board of Governors of the Federal Reserve BILLING CODE P
enforcement, to security personnel for System, March 1, 2018.
the called party for the purpose of
Ann E. Misback,
identifying the party responsible for the
threatening call. Carriers now have a Secretary of the Board. DEPARTMENT OF HEALTH AND
recordkeeping requirement in order to [FR Doc. 2018–04592 Filed 3–6–18; 8:45 am] HUMAN SERVICES
quickly provide law enforcement with BILLING CODE P
Food and Drug Administration
information relating to threatening calls.
The Commission also amended rules [Docket No. FDA–2011–N–0776]
to allow non-public emergency services FEDERAL RESERVE SYSTEM
to receive the CPN of all incoming calls Agency Information Collection
Formations of, Acquisitions by, and Activities; Proposed Collection;
from blocked numbers requesting Mergers of Bank Holding Companies
assistance. The Commission believes Comment Request; Reclassification
amending its rules to allow non-public Petitions for Medical Devices
The companies listed in this notice
emergency services access to blocked have applied to the Board for approval, AGENCY: Food and Drug Administration,
Caller ID promotes the public interest by pursuant to the Bank Holding Company HHS.
ensuring timely provision of emergency Act of 1956 (12 U.S.C. 1841 et seq.) ACTION: Notice.
services without undermining any (BHC Act), Regulation Y (12 CFR part
countervailing privacy interests. 225), and all other applicable statutes SUMMARY: The Food and Drug
Carriers now have a recordkeeping and regulations to become a bank Administration (FDA or Agency) is
requirement in order to provide holding company and/or to acquire the announcing an opportunity for public
emergency serve providers with the assets or the ownership of, control of, or comment on the proposed collection of
information they need to assist callers. the power to vote shares of a bank or certain information by the Agency.
Federal Communications Commission. bank holding company and all of the Under the Paperwork Reduction Act of
banks and nonbanking companies 1995 (PRA), Federal Agencies are
Marlene H. Dortch,
owned by the bank holding company, required to publish notice in the
Secretary, Office of the Secretary.
including the companies listed below. Federal Register concerning each
[FR Doc. 2018–04567 Filed 3–6–18; 8:45 am] proposed collection of information,
The applications listed below, as well
BILLING CODE 6712–01–P
as other related filings required by the including each proposed extension of an
Board, are available for immediate existing collection of information, and
inspection at the Federal Reserve Bank to allow 60 days for public comment in
FEDERAL RESERVE SYSTEM indicated. The applications will also be response to the notice. This notice
available for inspection at the offices of solicits comments on information
Change in Bank Control Notices; collection related to Reclassification
the Board of Governors. Interested
Acquisitions of Shares of a Bank or Petitions for Medical Devices.
persons may express their views in
Bank Holding Company
writing on the standards enumerated in DATES: Submit either electronic or
The notificants listed below have the BHC Act (12 U.S.C. 1842(c)). If the written comments on the collection of
applied under the Change in Bank proposal also involves the acquisition of information by May 7, 2018.
Control Act (12 U.S.C. 1817(j)) and a nonbanking company, the review also ADDRESSES: You may submit comments
225.41 of the Board’s Regulation Y (12 includes whether the acquisition of the as follows. Please note that late,
CFR 225.41) to acquire shares of a bank nonbanking company complies with the untimely filed comments will not be
daltland on DSKBBV9HB2PROD with NOTICES

or bank holding company. The factors standards in section 4 of the BHC Act considered. Electronic comments must
that are considered in acting on the (12 U.S.C. 1843). Unless otherwise be submitted on or before May 7, 2018.
notices are set forth in paragraph 7 of noted, nonbanking activities will be The https://www.regulations.gov
the Act (12 U.S.C. 1817(j)(7)). conducted throughout the United States. electronic filing system will accept
The notices are available for Unless otherwise noted, comments comments until midnight Eastern Time
immediate inspection at the Federal regarding each of these applications at the end of May 7, 2018. Comments
Reserve Bank indicated. The notices must be received at the Reserve Bank received by mail/hand delivery/courier

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Federal Register / Vol. 83, No. 45 / Wednesday, March 7, 2018 / Notices 9745

proposed rule that would eliminate the reclassification from a higher to a lower class I provide an alternative route to
need for Forms FDA 3427 and 3429. class, thereby reducing the regulatory market in lieu of premarket approval for
However, because the proposed rule has requirements applicable to a particular class III devices. If approved, petitions
not been finalized, we continue to device type, or to seek reclassification requesting reclassification from class I
include the forms in the burden from a lower to a higher class, thereby or II, to a different class, may increase
estimate for this information collection. increasing the regulatory requirements requirements.
The reclassification provisions of the applicable to that device type. If
FD&C Act serve primarily as a vehicle approved, petitions requesting FDA estimates the burden of this
for manufacturers to seek classification from class III to class II or collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section FDA form No. responses per burden per Total hours
respondents responses
respondent response

Supporting data for reclassification peti-
tion—21 CFR 860.123 ......................... ........................ 6 1 6 497 2,982
Supplemental Data Sheet ........................ 3427 6 1 6 1.5 9
General Device Classification Question-
naire ...................................................... 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 SUMMARY: In compliance with the Information Collection Request Title:
received in the last 3 years, FDA requirement of the Paperwork 0990–0263—Extension Protection of
anticipates that six petitions will be Reduction Act of 1995, the Office of the Human Subjects Assurance
submitted each year. The time required Secretary (OS), Department of Health Identification/IRB Certification/
to prepare and submit a reclassification and Human Services, is publishing the Declaration of Exemption (Common
petition, including the time needed to following summary of a proposed Rule) form.
assemble supporting data, averages 500 collection for public comment. Abstract: Assistant Secretary for
hours per petition. This average is based Health, Office for Human Research
DATES: Comments on the ICR must be
upon estimates by FDA administrative Protections is requesting an extension
received on or before April 6, 2018.
and technical staff who: (1) Are familiar on a currently approved information
with the requirements for submission of ADDRESSES: Submit your comments to collection by the Office of Management
a reclassification petition, (2) have OIRA_submission@omb.eop.gov or via and Budget, OMB, on the Protection of
consulted and advised manufacturers on facsimile to (202) 395–5806. Human Subjects: Assurance
these requirements, and (3) have FOR FURTHER INFORMATION CONTACT: Identification/IRB Certification/
reviewed the documentation submitted. Sherrette Funn, Sherrette.Funn@hhs.gov Declaration of Exemption Form. That
The burden estimate for this or (202) 795–7714. When submitting form is designed to provide a simplified
information collection has not changed comments or requesting information, procedure for institutions engaged in
since the last OMB approval. please include the document identifier research conducted or supported by the
Dated: February 28, 2018. 0990–New–30D and project title for Department of Health and Human
Leslie Kux, reference. Services (HHS) to satisfy the
requirements of HHS regulations for the
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION: Interested protection of human subjects at 45 CFR
[FR Doc. 2018–04613 Filed 3–6–18; 8:45 am]
persons are invited to send comments 46.103. The respondents for this
BILLING CODE 4164–01–P regarding this burden estimate or any collection are institutions engaged in
other aspect of this collection of research involving human subjects
information, including any of the where the research is supported by
DEPARTMENT OF HEALTH AND following subjects: (1) The necessity and HHS. Institutional use of the form is
HUMAN SERVICES utility of the proposed information also relied upon by other federal
collection for the proper performance of departments and agencies that have
[Document Identifier: OS–0990–0263] the agency’s functions; (2) the accuracy codified or follow the Federal Policy for
of the estimated burden; (3) ways to the Protection of Human Subjects
Agency Information Collection enhance the quality, utility, and clarity (Common Rule) which is identical to 45
Request; 30-Day Public Comment of the information to be collected; and CFR part 46, subpart A.
Request (4) the use of automated collection Likely Respondents: Individuals,
AGENCY: Office of the Secretary, HHS. techniques or other forms of information business or other for-profit, not for-
technology to minimize the information profit institutions, Federal, State, Local
ACTION: Notice.
collection burden. or Tribal Governments.
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Document Created: 2018-03-07 01:27:31
Document Modified: 2018-03-07 01:27:31

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		Submit either electronic or written comments on the collection of information by May 7, 2018.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		83 FR 9743

83 FR 9743 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 45 (March 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration