83 FR 38151 - 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 83, Issue 150 (August 3, 2018)

Page Range		38151-38153
FR Document		2018-16618

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 83 Issue 150 (Friday, August 3, 2018)

[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38151-38153]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16618]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0405]


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

[[Page 38152]]

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 
September 4, 2018.

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: 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: 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

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), mandatory 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 and (2) 
immediately notify health professionals and device-user facilities of 
the order and to instruct such professionals and facilities to cease 
use of such device.
    FDA will then provide the person named in the cease distribution 
and notification order with the opportunity for an informal hearing on 
whether the order should be amended to require a mandatory recall of 
the device.
    If, after providing the opportunity for an informal hearing, FDA 
determines that such an order is necessary, the Agency may amend the 
order to require a mandatory recall.
    FDA issued part 810 to implement the provisions of section 518 of 
the FD&C Act. The information collected under the mandatory recall 
authority provisions will be used by FDA to implement mandatory 
recalls.
    In the Federal Register of February 22, 2018 (83 FR 7740), 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
   Collection activity/21 CFR        Number of     responses per   Total annual   Average burden    Total hours
             section                respondents     respondent       responses     per 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 burden
                 Collection activity/21 CFR section                     Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation of Notifications to Recipients--810.15(b)............               2                1                2                8               16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                            Table 3--Estimated Annual Third-Party Disclosure Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   Collection activity/21 CFR        Number of      disclosures    Total annual   Average burden    Total hours
             section                respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients--                   2               1               2              12              24
 810.15(a)-(c)..................
Notification to Recipients;                    2               1               2               4               8
 Follow-up--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.


[[Page 38153]]

    The burden estimate has not changed for information collection 
related to section 518(e) of the FD&C Act and part 810 since the last 
OMB approval.

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16618 Filed 8-2-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38151

regulation for investigational use. contained in 21 CFR parts 501, 573, and terms by the FD&C Act. Labeling
Section 409(b) of the FD&C Act (21 579. The labeling regulations are requirements for investigational food
U.S.C. 348(b)) specifies the information considered by FDA to be cross- additives are also set forth in various
that must be submitted by a petitioner referenced to § 571.1, which is the regulations contained in 21 CFR 501.
to establish the safety of a food additive subject of this same OMB clearance for The labeling regulations are considered
and to secure the issuance of a food additive petitions. by FDA to be cross-referenced to
regulation permitting its use. With regard to the investigational use § 570.17, which is the subject of this
To implement the provisions of § 409 of food additives, § 409(j) of the FD&C same OMB clearance for investigational
of the FD&C Act, we issued procedural Act (§ 409(j)) (21 U.S.C. 348(j)) provides food additive files.
regulations under 21 CFR part 571. that any food additive, or any food The information collected is
These procedural regulations are bearing or containing such an additive, necessary to protect the public health.
designed to specify more thoroughly the may be exempted from the requirements We use the information submitted by
information that must be submitted to of this section if intended solely for food manufacturers or food additive
meet the requirement set down in investigational use by qualified experts. manufacturers to ascertain whether the
broader terms by the FD&C Act. The Investigational use of a food additive is data establish the identity of the
regulations add no substantive typically to address the safety and/or substance, justify its intended effect in/
requirements to those indicated in the intended physical or technical effect of on the food, and establish that its
FD&C Act, but attempt to explain these the additive. intended use in/on food is safe.
requirements and provide a standard To implement the provisions of Description of Respondents:
format for submission to speed § 409(j), we issued regulations under 21 Respondents to this collection of
processing of the petition. Labeling CFR 570.17. These regulations are information are food manufacturers or
requirements for food additives designed to specify more thoroughly the food additive manufacturers.
intended for animal consumption are information that must be submitted to FDA estimates the burden of this
also set forth in various regulations meet the requirement set down in broad collection of information as follows:

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

Food Additive Petitions:
571.1(c) Moderate Category ......................................... 12 1 12 3,000 36,000
571.1(c) Complex Category .......................................... 12 1 12 10,000 120,000
571.6 Amendment of Petition ....................................... 2 1 2 1,300 2,600
Investigational Food Additive Files:
570.17 Moderate Category ........................................... 4 1 4 1,500 6,000
570.17 Complex Category ............................................ 5 1 5 5,000 25,000

Total Hours ............................................................ ........................ ........................ ........................ ........................ 189,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimate of the total approximately 1,300 hours. We estimate Dated: July 24, 2018.
annual responses on submissions that, annually, two respondents will Leslie Kux,
received during fiscal years 2016 and each submit one such amendment, for a Associate Commissioner for Policy.
2017. We base our estimate of the hours total of 2,600 hours. [FR Doc. 2018–16616 Filed 8–2–18; 8:45 am]
per response upon our experience with § 570.17 Moderate Category: For an BILLING CODE 4164–01–P
the petition and filing processes.
investigational food additive file
§ 571.1(c) Moderate Category: For a
food additive petition without complex without complex chemistry,
manufacturing, efficacy, or safety issues, DEPARTMENT OF HEALTH AND
chemistry, manufacturing, efficacy or HUMAN SERVICES
safety issues, the estimated time the estimated time requirement per file
requirement per petition is is approximately 1,500 hours. We Food and Drug Administration
approximately 3,000 hours. We estimate estimate that, annually, four
respondents will each submit one such [Docket No. FDA–2018–N–0405]
that, annually, 12 respondents will each
submit 1 such petition, for a total of file, for a total of 6,000 hours.
Agency Information Collection
36,000 hours. § 570.17 Complex Category: For an Activities; Submission for Office of
§ 571.1(c) Complex Category: For a investigational food additive file with Management and Budget Review;
food additive petition with complex complex chemistry, manufacturing, Comment Request; Medical Device
chemistry, manufacturing, efficacy and/ efficacy, and/or safety issues, the Recall Authority
or safety issues, the estimated time estimated time requirement per file is
requirement per petition is AGENCY: Food and Drug Administration,
amozie on DSK3GDR082PROD with NOTICES1

approximately 5,000 hours. We estimate
approximately 10,000 hours. We that, annually, five respondents will HHS.
estimate that, annually, 12 respondents ACTION: Notice.
each submit one such file, for a total of
will each submit 1 such petition, for a
25,000 hours. SUMMARY: The Food and Drug
total of 120,000 hours.
§ 571.6: For a food additive petition The burden for this information Administration (FDA) is announcing
amendment, the estimated time collected has not changed since the last that a proposed collection of
requirement per petition is OMB approval. information has been submitted to the

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38152 Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices

Office of Management and Budget SUPPLEMENTARY INFORMATION: In and to instruct such professionals and
(OMB) for review and clearance under compliance with 44 U.S.C. 3507, FDA facilities to cease use of such device.
the Paperwork Reduction Act of 1995. has submitted the following proposed FDA will then provide the person
collection of information to OMB for named in the cease distribution and
DATES: Fax written comments on the review and clearance.
collection of information by September notification order with the opportunity
4, 2018. Medical Device Recall Authority for an informal hearing on whether the
order should be amended to require a
ADDRESSES: To ensure that comments on OMB Control Number 0910–0432— mandatory recall of the device.
the information collection are received, Extension
If, after providing the opportunity for
OMB recommends that written This collection of information an informal hearing, FDA determines
comments be faxed to the Office of implements section 518(e) of the that such an order is necessary, the
Information and Regulatory Affairs, Federal Food, Drug, and Cosmetic Act Agency may amend the order to require
OMB, Attn: FDA Desk Officer, Fax: 202– (FD&C Act) (21 U.S.C. 360h(e)) and part a mandatory recall.
395–7285, or emailed to oira_ 810 (21 CFR part 810), mandatory FDA issued part 810 to implement the
submission@omb.eop.gov. All medical device recall authority
provisions of section 518 of the FD&C
comments should be identified with the provisions. Section 518(e) of the FD&C
Act. The information collected under
OMB control number 0910–0432. Also Act provides FDA with the authority to
the mandatory recall authority
include the FDA docket number found issue an order requiring an appropriate
provisions will be used by FDA to
in brackets in the heading of this person, including manufacturers,
implement mandatory recalls.
document. importers, distributors, and retailers of a
device, if FDA finds that there is In the Federal Register of February
FOR FURTHER INFORMATION CONTACT: reasonable probability that the device 22, 2018 (83 FR 7740), FDA published
Amber Sanford, Office of Operations, intended for human use would cause a 60-day notice requesting public
Food and Drug Administration, Three serious adverse health consequences or comment on the proposed collection of
White Flint North, 10A–12M, 11601 death, to: (1) Immediately cease information. No comments were
Landsdown St., North Bethesda, MD distribution of such device and (2) received.
20852, 301–796–8867, PRAStaff@ immediately notify health professionals FDA estimates the burden of this
fda.hhs.gov. and device-user facilities of the order collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Collection activity/21 CFR section responses per annual burden per Total hours
respondents respondent responses 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 Total Average
Number of
Collection activity/21 CFR section records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping

Documentation of Notifications to Recipients—810.15(b) ... 2 1 2 8 16
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Total Average
Number of disclosures
Collection activity/21 CFR section annual burden per Total hours
respondents per disclosures disclosure
respondent

Notification to Recipients—810.15(a)–(c) ............................ 2 1 2 12 24
amozie on DSK3GDR082PROD with NOTICES1

Notification to Recipients; Follow-up—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.

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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices 38153

The burden estimate has not changed comments be faxed to the Office of establishments at 5-year intervals (1998,
for information collection related to Information and Regulatory Affairs, 2003, and 2008) to observe and
section 518(e) of the FD&C Act and part OMB, Attn: FDA Desk Officer, Fax: 202– document trends in the occurrence of
810 since the last OMB approval. 395–7285, or emailed to oira_ the following foodborne illness risk
Dated: July 24, 2018. submission@omb.eop.gov. All factors:
Leslie Kux, comments should be identified with the • Food from Unsafe Sources,
Associate Commissioner for Policy.
OMB control number 0910–0799. Also • Poor Personal Hygiene,
include the FDA docket number found • Inadequate Cooking,
[FR Doc. 2018–16618 Filed 8–2–18; 8:45 am]
in brackets in the heading of this • Improper Holding/Time and
BILLING CODE 4164–01–P
document. Temperature, and
FOR FURTHER INFORMATION CONTACT: Ila • Contaminated Equipment/Cross-
DEPARTMENT OF HEALTH AND S. Mizrachi, Office of Operations, Food Contamination.
HUMAN SERVICES and Drug Administration, Three White FDA developed reports summarizing
Flint North, 10A–12M, 11601 the findings for each of the three data
Food and Drug Administration Landsdown St., North Bethesda, MD collection periods (1998, 2003, and
[Docket No. FDA–2018–N–0270] 20852, 301–796–7726, PRAStaff@ 2008) (Refs. 1 to 3). Data from all three
fda.hhs.gov. data collection periods were analyzed to
Agency Information Collection SUPPLEMENTARY INFORMATION: In detect trends in improvement or
Activities; Submission for Office of regression over time and to determine
compliance with 44 U.S.C. 3507, FDA
Management and Budget Review; whether progress had been made toward
has submitted the following proposed
Comment Request; Survey on the the goal of reducing the occurrence of
collection of information to OMB for
Occurrence of Foodborne Illness Risk foodborne illness risk factors in selected
review and clearance.
Factors in Selected Institutional retail and foodservice facility types (Ref.
Foodservice and Retail Food Stores Survey on the Occurrence of Foodborne 4).
Facility Types Illness Risk Factors in Selected Using this 10-year survey as a
Institutional Foodservice and Retail foundation, in 2013 to 2014, FDA
AGENCY: Food and Drug Administration,
Food Stores Facility Types initiated a new study in full service and
HHS.
ACTION: Notice. OMB Control Number 0910–0799— fast food restaurants. This study will
Reinstatement span 10 years with additional data
SUMMARY: The Food and Drug collections planned for 2017 to 2018
Administration (FDA) is announcing I. Background and 2021 to 2022.
that a proposed collection of From 1998 to 2008, FDA’s National FDA recently completed the baseline
information has been submitted to the Retail Food Team conducted a study to data collection in select healthcare,
Office of Management and Budget measure trends in the occurrence of school, and retail food store facility
(OMB) for review and clearance under foodborne illness risk factors, types in 2015 to 2016. This proposed
the Paperwork Reduction Act of 1995. preparation practices, and employee study will also span 10 years with
DATES: Fax written comments on the behaviors most commonly reported to additional data collections planned for
collection of information by September the Centers for Disease Control and 2019 to 2020 (the subject of this
4, 2018. Prevention as contributing factors to information collection request
ADDRESSES: To ensure that comments on foodborne illness outbreaks at the retail reinstatement) and 2023 to 2024 (which
the information collection are received, level. Specifically, data was collected by will be posted in the Federal Register at
OMB recommends that written FDA specialists in retail and foodservice the next renewal).

TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY
Facility type Description

Healthcare Facilities ............. Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible popu-
lations as defined as follows:
• Hospitals—A foodservice operation that provides for the nutritional needs of inpatients by preparing meals and
transporting them to the patient’s room and/or serving meals in a cafeteria setting (meals in the cafeteria may
also be served to hospital staff and visitors).
• Long-term care facilities—A foodservice operation that prepares meals for the residents in a group care living
setting such as nursing homes and assisted living facilities.
Note: For the purposes of this study, healthcare facilities that do not prepare or serve food to a highly susceptible
population, such as mental healthcare facilities, are not included in this facility type category.
Schools (K–12) ..................... Foodservice operations that have the primary function of preparing and serving meals for students in one or more
grade levels from kindergarten through grade 12. A school foodservice may be part of a public or private insti-
tution.
Retail Food Stores ............... Supermarkets and grocery stores that have a deli department/operation as described as follows:
• Deli department/operation—Areas in a retail food store where foods, such as luncheon meats and
cheeses, are sliced for the customers and where sandwiches and salads are prepared onsite or received
amozie on DSK3GDR082PROD with NOTICES1

from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may include:
• Salad bars, pizza stations, and other food bars managed by the deli department manager.
• Areas where other foods are cooked or prepared and offered for sale as ready-to-eat and are man-
aged by the deli department manager.
Data will also be collected in the following areas of a supermarket or grocery store, if present:

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Document Created: 2018-11-06 10:34:38
Document Modified: 2018-11-06 10:34:38

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 September 4, 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 38151

83 FR 38151 - 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 83, Issue 150 (August 3, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration