80 FR 33523 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

Page Range		33523-33524
FR Document		2015-14359

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.

Federal Register, Volume 80 Issue 113 (Friday, June 12, 2015)

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33523-33524]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14359]



[[Page 33523]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0793]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device Recall 
Authority

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 0910-0432. 
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.

Medical Device Recall Authority--21 CFR 810 (OMB Control Number 0910-
0432)--Extension

    This collection of information implements section 518(e) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and 
part 810 (21 CFR part 810), medical device recall authority provisions. 
Section 518(e) of the FD&C Act provides FDA with the authority to issue 
an order requiring an appropriate person, including manufacturers, 
importers, distributors, and retailers of a device, if FDA finds that 
there is reasonable probability that the device intended for human use 
would cause serious adverse health consequences or death, to: (1) 
Immediately cease distribution of such device; (2) immediately notify 
health professionals and device-user facilities of the order; and (3) 
instruct such professionals and facilities to cease use of such device.
    Further, the provisions under section 518(e) of the FD&C Act set 
out the following three-step procedure for issuance of a mandatory 
device recall order:
     If there is a reasonable probability that a device 
intended for human use would cause serious, adverse health consequences 
or death, FDA may issue a cease distribution and notification order 
requiring the appropriate person to immediately:
    [cir] Cease distribution of the device,
    [cir] notify health professionals and device user facilities of the 
order, and
    [cir] instruct those professionals and facilities to cease use of 
the device;
     FDA will provide the person named in the cease 
distribution and notification order with the opportunity for an 
informal hearing on whether the order should be modified, vacated, or 
amended to require a mandatory recall of the device; and
     After providing the opportunity for an informal hearing, 
FDA may issue a mandatory recall order if the Agency determines that 
such an order is necessary.
    The information collected under the recall authority provisions 
will be used by FDA to do the following: (1) Ensure that all devices 
entering the market are safe and effective; (2) accurately and 
immediately detect serious problems with medical devices; and (3) 
remove dangerous and defective devices from the market.
    In the Federal Register of March 11, 2015 (80 FR 13586), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Collection activity--21 CFR       Number of     responses per   Total annual     burden per      Total hours
             Section                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Collections Specified in the                   2               1               2               8              16
 Order--810.10(d)...............
Request for Regulatory Hearing--               1               1               1               8               8
 810.11(a)......................
Written Request for Review--                   1               1               1               8               8
 810.12(a-b)....................
Mandatory Recall Strategy--                    2               1               2              16              32
 810.14.........................
Periodic Status Reports--                      2              12              24              40             960
 810.16(a-b)....................
Termination Request--810.17(a)..               2               1               2               8              16
    Total Hours.................  ..............  ..............  ..............  ..............           1,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Collection activity--21 CFR       Number of      records per    Total annual     burden per      Total hours
             Section               recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Documentation of Notifications                 2               1               1               8               8
 to Recipients--810.15(b).......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 33524]]


                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
  Collection Activity--21 CFR      Number of    disclosures  per   Total annual     burden per      Total hours
            Section               respondents      respondent       disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients--                 2                 1               2              12              24
 810.15(a)-(c)................
Notification to Recipients;                  2                 1               2               4               8
 Followup--810.15(d)..........
Notification of Consignees by               10                 1              10               1              10
 Recipients--810.15(e)........
    Total.....................  ..............  ................  ..............  ..............              42
----------------------------------------------------------------------------------------------------------------
\1\ There 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.
[FR Doc. 2015-14359 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices 33523

DEPARTMENT OF HEALTH AND and Drug Administration, 8455 would cause serious, adverse health
HUMAN SERVICES Colesville Rd., COLE–14526, Silver consequences or death, FDA may issue
Spring, MD 20993–0002, a cease distribution and notification
Food and Drug Administration PRAStaff@fda.hhs.gov. order requiring the appropriate person
[Docket No. FDA–2011–N–0793] SUPPLEMENTARY INFORMATION: In to immediately:
compliance with 44 U.S.C. 3507, FDA Æ Cease distribution of the device,
Agency Information Collection has submitted the following proposed Æ notify health professionals and
Activities; Submission for Office of collection of information to OMB for device user facilities of the order, and
Management and Budget Review; review and clearance.
Comment Request; Medical Device Æ instruct those professionals and
Recall Authority Medical Device Recall Authority—21 facilities to cease use of the device;
CFR 810 (OMB Control Number 0910– • FDA will provide the person named
AGENCY: Food and Drug Administration, 0432)—Extension in the cease distribution and
HHS. notification order with the opportunity
This collection of information
ACTION: Notice. implements section 518(e) of the for an informal hearing on whether the
SUMMARY: The Food and Drug Federal Food, Drug, and Cosmetic Act order should be modified, vacated, or
Administration (FDA) is announcing (FD&C Act) (21 U.S.C. 360h(e)) and part amended to require a mandatory recall
that a proposed collection of 810 (21 CFR part 810), medical device of the device; and
information has been submitted to the recall authority provisions. Section • After providing the opportunity for
Office of Management and Budget 518(e) of the FD&C Act provides FDA an informal hearing, FDA may issue a
(OMB) for review and clearance under with the authority to issue an order mandatory recall order if the Agency
the Paperwork Reduction Act of 1995. requiring an appropriate person, determines that such an order is
DATES: Fax written comments on the including manufacturers, importers, necessary.
collection of information by July 13, distributors, and retailers of a device, if The information collected under the
2015. FDA finds that there is reasonable recall authority provisions will be used
probability that the device intended for by FDA to do the following: (1) Ensure
ADDRESSES: To ensure that comments on
human use would cause serious adverse that all devices entering the market are
the information collection are received, health consequences or death, to: (1)
OMB recommends that written safe and effective; (2) accurately and
Immediately cease distribution of such immediately detect serious problems
comments be faxed to the Office of
device; (2) immediately notify health with medical devices; and (3) remove
Information and Regulatory Affairs,
professionals and device-user facilities dangerous and defective devices from
OMB, Attn: FDA Desk Officer, FAX:
of the order; and (3) instruct such the market.
202–395–7285, or emailed to
professionals and facilities to cease use
oira_submission@omb.eop.gov. All In the Federal Register of March 11,
of such device.
comments should be identified with the Further, the provisions under section 2015 (80 FR 13586), FDA published a
OMB control number 0910–0432. Also 518(e) of the FD&C Act set out the 60-day notice requesting public
include the FDA docket number found following three-step procedure for comment on the proposed collection of
in brackets in the heading of this issuance of a mandatory device recall information. No comments were
document. order: received.
FOR FURTHER INFORMATION CONTACT: FDA • If there is a reasonable probability FDA estimates the burden of this
PRA Staff, Office of Operations, Food that a device intended for human use collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Collection activity—21 CFR Section responses per burden per Total hours
respondents responses
respondent response

Collections Specified in the Order—810.10(d) .................... 2 1 2 8 16
Request for Regulatory Hearing—810.11(a) ....................... 1 1 1 8 8
Written Request for Review—810.12(a–b) .......................... 1 1 1 8 8
Mandatory Recall Strategy—810.14 .................................... 2 1 2 16 32
Periodic Status Reports—810.16(a–b) ................................ 2 12 24 40 960
Termination Request—810.17(a) ......................................... 2 1 2 8 16
Total Hours ................................................................... ........................ ........................ ........................ ........................ 1,040
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Collection activity—21 CFR Section records per burden per Total hours
recordkeepers records
mstockstill on DSK4VPTVN1PROD with NOTICES

recordkeeper recordkeeping

Documentation of Notifications to Recipients—810.15(b) ... 2 1 1 8 8
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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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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Document Created: 2018-02-22 10:16:04
Document Modified: 2018-02-22 10:16:04

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 33523

80 FR 33523 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration