Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping, 44420-44422 [2017-20245]
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44420
Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
on average would be needed per
response for certifications which
accompany NDA, BLA, PMA, HDE,
510(k), and ANDA marketing
applications and submissions. It is
assumed that the sponsor/applicant/
submitter has electronic capabilities
allowing them to retrieve the
information necessary to complete the
form in an efficient manner.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
(investigational
applications)
FDA center activity
Number of
respondents
(marketing
applications)
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
CDER
New Applications (IND) ................
Clinical Protocol Amendments
(IND).
New Marketing Applications/Resubmissions (NDA/BLA).
Clinical Amendments to Marketing
Applications.
Efficacy Supplements/Resubmissions.
1,669
15,285
........................
........................
1
1
1,669
15,285
0.25 (15 minutes) ..
0.25 (15 minutes) ..
417
3,821
............................
198
1
198
0.75 (45 minutes) ..
149
............................
1,067
1
1,067
0.75 (45 minutes) ..
800
............................
219
1
219
0.75 (45 minutes) ..
164
CBER
New Applications (IND) ................
Clinical Protocol Amendments
(IND).
New Marketing Applications/Resubmissions (NDA/BLA).
Clinical Amendments to Marketing
Applications.
Efficacy Supplements/Resubmissions (BLA only).
381
456
........................
........................
1
1
381
456
0.25 (15 minutes) ..
0.25 (15 minutes) ..
95
114
............................
54
1
54
0.75 (45 minutes) ..
41
............................
0
1
0
0.75 (45 minutes) ..
0
............................
34
1
34
0.75 (45 minutes) ..
26
1
330
0.75 (45 minutes) ..
247
CDRH
New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to
contain clinical data).
............................
330
OGD
Original Applications .....................
Bioequivalence
Supplements/
Amendments.
............................
............................
1,036
698
1
1
........................
........................
0.75 (45 minutes) ..
0.75 (45 minutes) ..
777
524
Total ......................................
............................
........................
........................
........................
...............................
7,175
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–20227 Filed 9–21–17; 8:45 am]
[Docket No. FDA–2010–N–0622]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Color Additive
Certification Requests and
Recordkeeping
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:
VerDate Sep<11>2014
18:11 Sep 21, 2017
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Sfmt 4703
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 October 23,
2017.
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 0910–0216. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
E:\FR\FM\22SEN1.SGM
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Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
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.
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.
FOR FURTHER INFORMATION CONTACT:
Color Additive Certification Requests
and Recordkeeping—21 CFR Part 80
OMB Control Number 0910–0216—
Extension
We have regulatory oversight for color
additives used in foods, drugs,
cosmetics, and medical devices. Section
721(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379e(a))
provides that a color additive shall be
deemed to be unsafe unless it meets the
requirements of a listing regulation,
including any requirement for batch
certification, and is used in accordance
with the regulation. We list color
additives that have been shown to be
safe for their intended uses in Title 21
of the Code of Federal Regulations
(CFR). We require batch certification for
all color additives listed in 21 CFR part
74 and for all color additives
provisionally listed in 21 CFR part 82.
Color additives listed in 21 CFR part 73
are exempted from certification.
The requirements for color additive
certification are described in 21 CFR
part 80. In the certification procedure, a
representative sample of a new batch of
color additive, accompanied by a
‘‘request for certification’’ that provides
information about the batch, must be
submitted to FDA’s Office of Cosmetics
and Colors. FDA personnel perform
chemical and other analyses of the
representative sample and, providing
the sample satisfies all certification
requirements, issue a certification lot
number for the batch. We charge a fee
for certification based on the batch
weight and require manufacturers to
keep records of the batch pending and
after certification.
Under § 80.21, a request for
certification must include: Name of
color additive, manufacturer’s batch
number and weight in pounds, name
and address of manufacturer, storage
conditions, statement of use(s),
certification fee, and signature of person
requesting certification. Under § 80.22, a
request for certification must include a
sample of the batch of color additive
that is the subject of the request. The
sample must be labeled to show: Name
of color additive, manufacturer’s batch
number and quantity, and name and
address of person requesting
certification. Under § 80.39, the person
to whom a certificate is issued must
keep complete records showing the
disposal of all of the color additive
covered by the certificate. Such records
are to be made available upon request to
any accredited representative of FDA
until at least 2 years after disposal of all
of the color additive.
The purpose for collecting this
information is to help us assure that
only safe color additives will be used in
foods, drugs, cosmetics, and medical
devices sold in the United States. The
required information is unique to the
batch of color additive that is the subject
of a request for certification. The
manufacturer’s batch number is used for
temporarily identifying a batch of color
additive until FDA issues a certification
lot number and for identifying a
certified batch during inspections. The
44421
manufacturer’s batch number also aids
in tracing the disposal of a certified
batch or a batch that has been denied
certification for noncompliance with the
color additive regulations. The
manufacturer’s batch weight is used for
assessing the certification fee. The batch
weight also is used to account for the
disposal of a batch of certified or
certification-denied color additive. The
batch weight can be used in a recall to
determine whether all unused color
additive in the batch has been recalled.
The manufacturer’s name and address
and the name and address of the person
requesting certification are used to
contact the person responsible should a
question arise concerning compliance
with the color additive regulations.
Information on storage conditions
pending certification is used to evaluate
whether a batch of certified color
additive is inadvertently or
intentionally altered in a manner that
would make the sample submitted for
certification analysis unrepresentative
of the batch. We check storage
information during inspections.
Information on intended uses for a batch
of color additive is used to assure that
a batch of certified color additive will be
used in accordance with the
requirements of its listing regulation.
The statement of the fee on a
certification request is used for
accounting purposes so that a person
requesting certification can be notified
promptly of any discrepancies.
In the Federal Register of June 14,
2017 (82 FR 27259), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
80.21; Request for Certification ...............................
80.22; Sample to Accompany Request ...................
38
38
198
198
7,524
7,524
0.17 (10 minutes) ......
0.05 (3 minutes) ........
1,279
376
Total ..................................................................
........................
........................
........................
0.22 (13 minutes) ......
1,655
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
recordkeepers
21 CFR section/activity
80.39; Record of Distribution .................................
1 There
Number of
records per
recordkeeper
38
Total annual
records
198
7,524
Average
burden per
recordkeeping
.25 (15 minutes) ..........
are no capital costs or operating and maintenance costs associated with this collection of information.
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18:11 Sep 21, 2017
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E:\FR\FM\22SEN1.SGM
22SEN1
Total hours
1,881
44422
Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
We base our estimate on our review
of the certification requests received
over the past 3 fiscal years (FY). The
annual burden estimate for this
information collection is 3,536 hours.
The estimated reporting burden for this
information collection is 1,655 hours
and the estimated recordkeeping burden
for this information collection is 1,881
hours. From FY 2014 to FY 2016, we
processed an average of 7,524 responses
(requests for certification of batches of
color additives) per year. There were 38
different respondents, corresponding to
an average of approximately 198
responses from each respondent per
year. Using information from industry
personnel, we estimate that an average
of 0.22 hour per response is required for
reporting (preparing certification
requests and accompanying samples)
and an average of 0.25 hour per
response is required for recordkeeping.
FDA’s web-based Color Certification
information system allows submitters to
request color certification online, follow
their submissions through the process,
and obtain information on account
status. The system sends back the
certification results electronically,
allowing submitters to sell their
certified color before receiving hardcopy
certificates. Any delays in the system
result only from shipment of color
additive samples to FDA’s Office of
Cosmetics and Colors for analysis.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20245 Filed 9–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0501]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Third Party
Disclosure and Recordkeeping
Requirements for Reportable Food
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.
SUMMARY:
VerDate Sep<11>2014
18:11 Sep 21, 2017
Jkt 241001
Fax written comments on the
collection of information by October 23,
2017.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0643. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
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:
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:
Third Party Disclosure and
Recordkeeping Requirements for
Reportable Food—21 U.S.C. 350f
OMB Control Number 0910–0643—
Extension
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Food and Drug Administration
Amendments Act of 2007 (FDAAA)
(Pub. L. 110–85), requires the
establishment of a Reportable Food
Registry (the Registry) by which
instances of reportable food must be
submitted to FDA by responsible parties
and may be submitted by public health
officials. Section 417 of the FD&C Act
(21 U.S.C. 350f) defines ‘‘reportable
food’’ as an ‘‘article of food (other than
infant formula) for which there is a
reasonable probability that the use of, or
exposure to, such article of food will
cause serious adverse health
consequences or death to humans or
animals.’’ (Section 417(a)(2) of the FD&C
Act.) We believe that the most efficient
and cost effective means to implement
the Registry is by utilizing our
electronic Safety Reporting Portal. The
information collection provisions
associated with the submission of
reportable food reports has been
approved under OMB control number
0910–0643.
In conjunction with the reportable
foods requirements, section 417 of the
FD&C Act also establishes third party
disclosure and recordkeeping burdens.
Specifically, we may require the
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
responsible party to notify the
immediate previous source(s) and/or
immediate subsequent recipient(s) of a
reportable food (section 417(d)(6)(B)(i)
to (ii) of the FD&C Act). Similarly, we
may also require the responsible party
that is notified (i.e., the immediate
previous source and/or immediate
subsequent recipient) to notify their
own immediate previous source(s) and/
or immediate subsequent recipient(s) of
a reportable food (section 417(d)(7)(C)(i)
to (ii) of the FD&C Act).
Notification to the immediate
previous source(s) and immediate
subsequent recipient(s) of the article of
food may be accomplished by electronic
communication methods such as email,
fax, or text messaging or by telegrams,
mailgrams, or first-class letters.
Notification may also be accomplished
by telephone call or other personal
contacts but we recommend that such
notifications also be confirmed by one
of the previous methods and/or
documented in an appropriate manner.
We may require that the notification
include any or all of the following data
elements: (1) The date on which the
article of food was determined to be a
reportable food; (2) a description of the
article of food including the quantity or
amount; (3) the extent and nature of the
adulteration; (4) the results of any
investigation of the cause of the
adulteration if it may have originated
with the responsible party, if known; (5)
the disposition of the article of food,
when known; (6) product information
typically found on packaging including
product codes, use-by dates, and the
names of manufacturers, packers, or
distributors sufficient to identify the
article of food; (7) contact information
for the responsible party; (8) contact
information for parties directly linked in
the supply chain and notified under
section 417(d)(6)(B) or 417(d)(7)(C) of
the FD&C Act, as applicable; (9) the
information required by FDA to be
included in the notification provided by
the responsible party involved under
section 417(d)(6)(B) or 417(d)(7)(C) of
the FD&C Act or required to report
under section 417(d)(7)(A) of the FD&C
Act; and (10) the unique number
described in section 417(d)(4) of the
FD&C Act (section 417(d)(6)(B)(iii)(I),
(d)(7)(C)(iii)(I), and (e) of the FD&C Act).
We may also require that the
notification provides information about
the actions that the recipient of the
notification will perform and/or any
other information we may require
(section 417(d)(6)(B)(iii)(II) and (III),
(d)(7)(C)(iii)(II) and (III) of the FD&C
Act).
Section 417(g) of the FD&C Act
requires that responsible persons
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44420-44422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20245]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0622]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Color Additive
Certification Requests and Recordkeeping
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 October
23, 2017.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0216.
Also include the FDA docket number found in brackets in the heading of
this document.
[[Page 44421]]
FOR FURTHER INFORMATION CONTACT: 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.
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.
Color Additive Certification Requests and Recordkeeping--21 CFR Part 80
OMB Control Number 0910-0216--Extension
We have regulatory oversight for color additives used in foods,
drugs, cosmetics, and medical devices. Section 721(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379e(a)) provides that a color
additive shall be deemed to be unsafe unless it meets the requirements
of a listing regulation, including any requirement for batch
certification, and is used in accordance with the regulation. We list
color additives that have been shown to be safe for their intended uses
in Title 21 of the Code of Federal Regulations (CFR). We require batch
certification for all color additives listed in 21 CFR part 74 and for
all color additives provisionally listed in 21 CFR part 82. Color
additives listed in 21 CFR part 73 are exempted from certification.
The requirements for color additive certification are described in
21 CFR part 80. In the certification procedure, a representative sample
of a new batch of color additive, accompanied by a ``request for
certification'' that provides information about the batch, must be
submitted to FDA's Office of Cosmetics and Colors. FDA personnel
perform chemical and other analyses of the representative sample and,
providing the sample satisfies all certification requirements, issue a
certification lot number for the batch. We charge a fee for
certification based on the batch weight and require manufacturers to
keep records of the batch pending and after certification.
Under Sec. 80.21, a request for certification must include: Name
of color additive, manufacturer's batch number and weight in pounds,
name and address of manufacturer, storage conditions, statement of
use(s), certification fee, and signature of person requesting
certification. Under Sec. 80.22, a request for certification must
include a sample of the batch of color additive that is the subject of
the request. The sample must be labeled to show: Name of color
additive, manufacturer's batch number and quantity, and name and
address of person requesting certification. Under Sec. 80.39, the
person to whom a certificate is issued must keep complete records
showing the disposal of all of the color additive covered by the
certificate. Such records are to be made available upon request to any
accredited representative of FDA until at least 2 years after disposal
of all of the color additive.
The purpose for collecting this information is to help us assure
that only safe color additives will be used in foods, drugs, cosmetics,
and medical devices sold in the United States. The required information
is unique to the batch of color additive that is the subject of a
request for certification. The manufacturer's batch number is used for
temporarily identifying a batch of color additive until FDA issues a
certification lot number and for identifying a certified batch during
inspections. The manufacturer's batch number also aids in tracing the
disposal of a certified batch or a batch that has been denied
certification for noncompliance with the color additive regulations.
The manufacturer's batch weight is used for assessing the certification
fee. The batch weight also is used to account for the disposal of a
batch of certified or certification-denied color additive. The batch
weight can be used in a recall to determine whether all unused color
additive in the batch has been recalled. The manufacturer's name and
address and the name and address of the person requesting certification
are used to contact the person responsible should a question arise
concerning compliance with the color additive regulations. Information
on storage conditions pending certification is used to evaluate whether
a batch of certified color additive is inadvertently or intentionally
altered in a manner that would make the sample submitted for
certification analysis unrepresentative of the batch. We check storage
information during inspections. Information on intended uses for a
batch of color additive is used to assure that a batch of certified
color additive will be used in accordance with the requirements of its
listing regulation. The statement of the fee on a certification request
is used for accounting purposes so that a person requesting
certification can be notified promptly of any discrepancies.
In the Federal Register of June 14, 2017 (82 FR 27259), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.21; Request for Certification............ 38 198 7,524 0.17 (10 minutes)......................... 1,279
80.22; Sample to Accompany Request.......... 38 198 7,524 0.05 (3 minutes).......................... 376
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. 0.22 (13 minutes)......................... 1,655
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
21 CFR section/activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.39; Record of Distribution.............. 38 198 7,524 .25 (15 minutes)........................... 1,881
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 44422]]
We base our estimate on our review of the certification requests
received over the past 3 fiscal years (FY). The annual burden estimate
for this information collection is 3,536 hours. The estimated reporting
burden for this information collection is 1,655 hours and the estimated
recordkeeping burden for this information collection is 1,881 hours.
From FY 2014 to FY 2016, we processed an average of 7,524 responses
(requests for certification of batches of color additives) per year.
There were 38 different respondents, corresponding to an average of
approximately 198 responses from each respondent per year. Using
information from industry personnel, we estimate that an average of
0.22 hour per response is required for reporting (preparing
certification requests and accompanying samples) and an average of 0.25
hour per response is required for recordkeeping.
FDA's web-based Color Certification information system allows
submitters to request color certification online, follow their
submissions through the process, and obtain information on account
status. The system sends back the certification results electronically,
allowing submitters to sell their certified color before receiving
hardcopy certificates. Any delays in the system result only from
shipment of color additive samples to FDA's Office of Cosmetics and
Colors for analysis.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20245 Filed 9-21-17; 8:45 am]
BILLING CODE 4164-01-P
