Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping, 22688-22689 [2014-09200]
Download as PDF
<![CDATA[
22688
Federal Register / Vol. 79, No. 78 / Wednesday, April 23, 2014 / Notices
On page 1 of the electronic questions
under ‘‘Select an Application Type’’
users must select ‘‘Original’’ and then
choose either, ‘‘Abbreviated New
Animal Drug Application (ANADA)—
under provisions of 512(b)(2) of FFDCA
[the FD&C Act]’’ (21 U.S.C. 360b(b)(2));
or ‘‘Abbreviated New Animal Drug
Application (ANADA)—for certain
combination pioneer products approved
under provisions of 512(d)(4) of FD&C
Act.’’ If they select the first ANADA
type, they will be charge 100 percent of
the application fee. If they select the
second ANADA type, they will be
charged at a rate of 50 percent of the
original application fee. To facilitate the
application process in this regard, on
Form FDA 3728 we have added a line
in section 3 that allows applicants to
select the option, ‘‘3.2 Original
Abbreviated New Animal Drug
Application (ANADA)—for certain
combination pioneer products approved
under provisions of section 512(d)(4) of
the FD&C Act.’’
In the Federal Register of February
18, 2014 (79 FR 9224), 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
FDA form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
3728 .........................................................
20
2
40
.08 (4.8 minutes) ........................
3.2
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are generic animal drug
applicants. Based on data for the past 3
years, FDA estimates there are
approximately 20 submissions annually
and a total of 3.2 burden hours.
Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09201 Filed 4–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0252]
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
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 May 23,
2014.
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:
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:37 Apr 22, 2014
Jkt 232001
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.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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 (the FD&C 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
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
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
E:\FR\FM\23APN1.SGM
23APN1
22689
Federal Register / Vol. 79, No. 78 / Wednesday, April 23, 2014 / Notices
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 February 6,
2014 (79 FR 7199), FDA published a 60day 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
responses
per respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden
per response
Total hours
80.21; Request for Certification .......................
80.22; Sample to accompany request .............
35
35
199
199
6,965
6,965
0.17
0.05
1,184
348
Total ..........................................................
..............................
..............................
..............................
0.22
1,532
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
21 CFR section; activity
Number of
recordkeepers
Number of
records per
recordkeeping
Total annual
records
Average burden
per recordkeeping
Total hours
80.39; Record of Distribution ...........................
35
199
6,965
0.25
1,741
wreier-aviles on DSK5TPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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 3,273 hours.
The estimated reporting burden for this
information collection is 1,532 hours
and the estimated recordkeeping burden
for this information collection is 1,741
hours. From FY 2011 to FY 2013, we
processed an average of 6,954 responses
(requests for certification of batches of
color additives) per year. There were 35
different respondents, corresponding to
an average of approximately 199
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.
Our 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
VerDate Mar<15>2010
15:37 Apr 22, 2014
Jkt 232001
certification results electronically,
allowing submitters to sell their
certified color before receiving hard
copy certificates. Any delays in the
system result only from shipment of
color additive samples to FDA’s Office
of Cosmetics and Colors for analysis.
SUMMARY:
Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DATES:
[FR Doc. 2014–09200 Filed 4–22–14; 8:45 am]
ADDRESSES:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0078]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Drug User
Fee Act Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00072
Fmt 4703
Sfmt 4703
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.
Fax written comments on the
collection of information by May 23,
2014.
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 0910–0539. Also
include the FDA docket number found
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\23APN1.SGM
23APN1
]]>Agencies
[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22688-22689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09200]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0252]
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 May 23,
2014.
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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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 (the FD&C 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
[[Page 22689]]
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 February 6, 2014 (79 FR 7199), 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 Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.21; Request for Certification............................... 35 199 6,965 0.17 1,184
80.22; Sample to accompany request............................. 35 199 6,965 0.05 348
----------------------------------------------------------------------------------------
Total...................................................... ................. ................. ................. 0.22 1,532
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden
21 CFR section; activity recordkeepers per recordkeeping records per recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
80.39; Record of Distribution............................. 35 199 6,965 0.25 1,741
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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 3,273 hours. The estimated reporting
burden for this information collection is 1,532 hours and the estimated
recordkeeping burden for this information collection is 1,741 hours.
From FY 2011 to FY 2013, we processed an average of 6,954 responses
(requests for certification of batches of color additives) per year.
There were 35 different respondents, corresponding to an average of
approximately 199 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.
Our 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 hard
copy 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: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09200 Filed 4-22-14; 8:45 am]
BILLING CODE 4160-01-P
