Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority, 38151-38153 [2018-16618]
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Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices
regulation for investigational use.
Section 409(b) of the FD&C Act (21
U.S.C. 348(b)) specifies the information
that must be submitted by a petitioner
to establish the safety of a food additive
and to secure the issuance of a
regulation permitting its use.
To implement the provisions of § 409
of the FD&C Act, we issued procedural
regulations under 21 CFR part 571.
These procedural regulations are
designed to specify more thoroughly the
information that must be submitted to
meet the requirement set down in
broader terms by the FD&C Act. The
regulations add no substantive
requirements to those indicated in the
FD&C Act, but attempt to explain these
requirements and provide a standard
format for submission to speed
processing of the petition. Labeling
requirements for food additives
intended for animal consumption are
also set forth in various regulations
terms by the FD&C Act. Labeling
requirements for investigational food
additives are also set forth in various
regulations contained in 21 CFR 501.
The labeling regulations are considered
by FDA to be cross-referenced to
§ 570.17, which is the subject of this
same OMB clearance for investigational
food additive files.
The information collected is
necessary to protect the public health.
We use the information submitted by
food manufacturers or food additive
manufacturers to ascertain whether the
data establish the identity of the
substance, justify its intended effect in/
on the food, and establish that its
intended use in/on food is safe.
Description of Respondents:
Respondents to this collection of
information are food manufacturers or
food additive manufacturers.
FDA estimates the burden of this
collection of information as follows:
contained in 21 CFR parts 501, 573, and
579. The labeling regulations are
considered by FDA to be crossreferenced to § 571.1, which is the
subject of this same OMB clearance for
food additive petitions.
With regard to the investigational use
of food additives, § 409(j) of the FD&C
Act (§ 409(j)) (21 U.S.C. 348(j)) provides
that any food additive, or any food
bearing or containing such an additive,
may be exempted from the requirements
of this section if intended solely for
investigational use by qualified experts.
Investigational use of a food additive is
typically to address the safety and/or
intended physical or technical effect of
the additive.
To implement the provisions of
§ 409(j), we issued regulations under 21
CFR 570.17. These regulations are
designed to specify more thoroughly the
information that must be submitted to
meet the requirement set down in broad
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Food Additive Petitions:
571.1(c) Moderate Category .........................................
571.1(c) Complex Category ..........................................
571.6 Amendment of Petition .......................................
Investigational Food Additive Files:
570.17 Moderate Category ...........................................
570.17 Complex Category ............................................
Total Hours ............................................................
amozie on DSK3GDR082PROD with NOTICES1
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
12
12
2
1
1
1
12
12
2
3,000
10,000
1,300
36,000
120,000
2,600
4
5
1
1
4
5
1,500
5,000
6,000
25,000
........................
........................
........................
........................
189,600
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the total
annual responses on submissions
received during fiscal years 2016 and
2017. We base our estimate of the hours
per response upon our experience with
the petition and filing processes.
§ 571.1(c) Moderate Category: For a
food additive petition without complex
chemistry, manufacturing, efficacy or
safety issues, the estimated time
requirement per petition is
approximately 3,000 hours. We estimate
that, annually, 12 respondents will each
submit 1 such petition, for a total of
36,000 hours.
§ 571.1(c) Complex Category: For a
food additive petition with complex
chemistry, manufacturing, efficacy and/
or safety issues, the estimated time
requirement per petition is
approximately 10,000 hours. We
estimate that, annually, 12 respondents
will each submit 1 such petition, for a
total of 120,000 hours.
§ 571.6: For a food additive petition
amendment, the estimated time
requirement per petition is
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approximately 1,300 hours. We estimate
that, annually, two respondents will
each submit one such amendment, for a
total of 2,600 hours.
§ 570.17 Moderate Category: For an
investigational food additive file
without complex chemistry,
manufacturing, efficacy, or safety issues,
the estimated time requirement per file
is approximately 1,500 hours. We
estimate that, annually, four
respondents will each submit one such
file, for a total of 6,000 hours.
§ 570.17 Complex Category: For an
investigational food additive file with
complex chemistry, manufacturing,
efficacy, and/or safety issues, the
estimated time requirement per file is
approximately 5,000 hours. We estimate
that, annually, five respondents will
each submit one such file, for a total of
25,000 hours.
The burden for this information
collected has not changed since the last
OMB approval.
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Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16616 Filed 8–2–18; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
SUMMARY:
E:\FR\FM\03AUN1.SGM
03AUN1
38152
Federal Register / Vol. 83, No. 150 / Friday, August 3, 2018 / Notices
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Fax written comments on the
collection of information by September
4, 2018.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0432. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
responses per
respondent
Number of
respondents
Collection activity/21 CFR section
Total
annual
responses
Average
burden per
response
Total hours
Collections Specified in the Order—810.10(d) ....................
Request for Regulatory Hearing—810.11(a) .......................
Written Request for Review—810.12(a)–(b) .......................
Mandatory Recall Strategy—810.14 ....................................
Periodic Status Reports—810.16(a)–(b) ..............................
Termination Request—810.17(a) .........................................
2
1
1
2
2
2
1
1
1
1
12
1
2
1
1
2
24
2
8
8
8
16
40
8
16
8
8
32
960
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
Collection activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Documentation of Notifications to Recipients—810.15(b) ...
2
1
2
8
16
Average
burden per
disclosure
Total hours
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
respondents
amozie on DSK3GDR082PROD with NOTICES1
Collection activity/21 CFR section
Number of
disclosures
per
respondent
Total
annual
disclosures
Notification to Recipients—810.15(a)–(c) ............................
Notification to Recipients; Follow-up—810.15(d) ................
Notification of Consignees by Recipients—810.15(e) .........
2
2
10
1
1
1
2
2
10
12
4
1
24
8
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
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
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0799. Also
include the FDA docket number found
in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0270]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Survey on the
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
Foodservice and Retail Food Stores
Facility Types
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
4, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Survey on the Occurrence of Foodborne
Illness Risk Factors in Selected
Institutional Foodservice and Retail
Food Stores Facility Types
OMB Control Number 0910–0799—
Reinstatement
I. Background
From 1998 to 2008, FDA’s National
Retail Food Team conducted a study to
measure trends in the occurrence of
foodborne illness risk factors,
preparation practices, and employee
behaviors most commonly reported to
the Centers for Disease Control and
Prevention as contributing factors to
foodborne illness outbreaks at the retail
level. Specifically, data was collected by
FDA specialists in retail and foodservice
38153
establishments at 5-year intervals (1998,
2003, and 2008) to observe and
document trends in the occurrence of
the following foodborne illness risk
factors:
• Food from Unsafe Sources,
• Poor Personal Hygiene,
• Inadequate Cooking,
• Improper Holding/Time and
Temperature, and
• Contaminated Equipment/CrossContamination.
FDA developed reports summarizing
the findings for each of the three data
collection periods (1998, 2003, and
2008) (Refs. 1 to 3). Data from all three
data collection periods were analyzed to
detect trends in improvement or
regression over time and to determine
whether progress had been made toward
the goal of reducing the occurrence of
foodborne illness risk factors in selected
retail and foodservice facility types (Ref.
4).
Using this 10-year survey as a
foundation, in 2013 to 2014, FDA
initiated a new study in full service and
fast food restaurants. This study will
span 10 years with additional data
collections planned for 2017 to 2018
and 2021 to 2022.
FDA recently completed the baseline
data collection in select healthcare,
school, and retail food store facility
types in 2015 to 2016. This proposed
study will also span 10 years with
additional data collections planned for
2019 to 2020 (the subject of this
information collection request
reinstatement) and 2023 to 2024 (which
will be posted in the Federal Register at
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 populations 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.
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 institution.
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
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 managed by the deli department manager.
Data will also be collected in the following areas of a supermarket or grocery store, if present:
Schools (K–12) .....................
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Retail Food Stores ...............
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]]>Agencies
[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38151-38153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16618]
-----------------------------------------------------------------------
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
