SUPPORTING STATEMENT
Terms of Clearance: None.
1. Circumstances
Making the Collection of Information Necessary
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.
We request the extension of OMB approval for the following collection of information requirements:
21 CFR 80.21 -- Reporting
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.
21 CFR 80.22 -- Reporting
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.
21 CFR 80.39 -- Recordkeeping
Under § 80.39, the person to whom a certificate is issued must keep complete records showing the disposal of all 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 the color additive.
2. Purpose
and Use of the Information Collection
As
described above, FDA’s regulations require that a
representative sample of each new batch of color additive,
accompanied by a “request for certification” that
provides information about the batch, be submitted to FDA’s
Office of Cosmetics and Colors. The
purpose for collecting this information is to help FDA assure that
only safe color additives will be used in FDA-regulated foods, drugs,
cosmetics, and medical devices. 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.
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 refused 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-rejected 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. FDA checks 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.
Description
of Respondents: The
likely respondents include businesses engaged in the manufacture of
color additives used in
FDA-regulated foods, drugs, cosmetics, and medical devices.
Respondents are from the private sector (for-profit businesses).
3. Use
of Improved Information Technology and Burden Reduction
On
February 13, 2006, FDA introduced a Web-based Color Certification
information system. The system was fully operational for FY 2007.
This 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. The agency estimates
that about ninety-five percent (95%) of the “requests for
certification” will be submitted electronically in the next
three years.
4. Efforts
to Identify Duplication and Use of Similar Information
To
the best of our knowledge, no other federal government agency is
engaged in the collection of this information. No other government
agency has either the need or the authority to request the
information required in a request for certification of a color
additive. There can be
no duplicative collection of this information because the required
information is unique to the batch of color additive that is the
subject of a request for certification.
5. Impact
on Small Businesses or Other Small Entities
FDA
estimates that ten percent (10%) of respondents are small businesses.
The reporting and recordkeeping requirements of these regulations
are mandated by the FD&C Act and there is no statutory exception
for small businesses.
FDA aids small businesses in complying with its requirements through
the agency’s Regional Small Business Representatives and
through the scientific and administrative staffs within the agency.
FDA has provided a Small Business Guide on the agency’s website
at http://www.fda.gov/oc/industry/.
6. Consequences
of Collecting the Information Less Frequently
Data
collection occurs occasionally. The
information in a request for color additive certification is required
by the FD&C Act and implementing regulations. Without this
information, FDA could not assure the safety of batches of color
additives. This information is collected once for each new batch of
a color additive and therefore cannot be collected less frequently.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
There
are no special circumstances associated with this collection of
information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the
Agency
In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal
Register of
February 6, 2014 (79 FR 7199). FDA received no comments in response
to the notice.
9. Explanation
of Any Payment or Gift to Respondents
FDA
does not provide any payments or gifts to respondents.
10. Assurance
of Confidentiality Provided to Respondents
Sections
80.21, 80.22, and 80.39 do not specify confidentiality. However, FDA
considers the information collected in the requests for color
additive certification to be privileged commercial information exempt
from release under the provisions of the Freedom of Information Act
(FOIA) to the maximum extent permitted by that statute and FDA
regulations. Confidentiality of the information submitted is
protected from disclosure under FOIA under sections 552(a) and (b) (5
U.S.C. 552(a) and (b)), and by part 20 of the agency’s
regulations (21 CFR part 20). The information also is safeguarded by
Section 301(j) of the FD&C Act (21 U.S.C. 331(j). Accordingly,
all color additive certification files are maintained in a secured
area.
12. Estimates
of Annualized Burden Hours and Costs
Description
of Respondents: The
likely respondents include businesses engaged in the manufacture of
color additives used in
FDA-regulated foods, drugs, cosmetics, and medical devices.
Respondents are from the private sector (for-profit businesses).
12 a. Annualized Hour Burden Estimate
FDA
estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
|
|||||
21 CFR Section; Activity |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
80.21; Request for certification |
35 |
199 |
6,965 |
0.17 |
1,184 |
80.22; Samples to accompany requests for certification |
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 Annual Recordkeeping Burden1
|
|||||
21 CFR Section; Activity |
No. of Recordkeepers |
No. of Records per Recordkeeping |
Total Annual Records |
Average Burden per Recordkeeping |
Total Hours |
80.39; Records 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. |
|||||
FDA bases its estimate on its 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, FDA 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, FDA estimates 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 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. FDA has estimated an increase in the estimated burden for reporting and recordkeeping. In Table 1, the number of respondents increased from 32 to 35. Also the number of responses increased from 5,932 to 6,965. In Table 2, the number of recordkeepers increased from 32 to 35 as well. Also, the number of records increased from 5,932 to 6,965.
12 b. Annualized Cost Burden Estimate
The annual hour cost burden to respondents is approximately $237,161.58 per year. FDA estimates that the average hourly wage for the employee preparing and submitting the request for certification would be equivalent to a GS-12/Step-1 level in the locality pay area of Washington-Baltimore in 2014, approximately $36.23/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to respondents to be $72.46/hour. Thus, the overall estimated cost incurred by the respondents is $237,161.58 (3,273 burden hours x $72.46/hour = $237,161.58).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There
are no capital, start-up, operating, or maintenance costs associated
with this collection.
14. Annualized
Cost to the
Federal Government
Section
721(e) of the FD&C Act (21 U.S.C. 379e(e)) provides that fees
must be charged for color additive certification “as may be
necessary to provide, maintain, and equip an adequate service for
such purposes.” Thus, it is required by law that there be no
cost to the federal government for color additive certification. As
noted above, FDA charges a fee for certification based on the batch
weight in accordance with § 80.10 (21 CFR 80.10).
15. Explanation
for Program Changes or Adjustments
This
is an approval request in which both the total annual number of
responses/records and the total annual hour burden are being
increased. The total annual number of responses/records increased
from 17,760 to 20,895 responses/records (an
increase of 3,135)
and the total annual hour burden has increased from 2,782 to 3,273
hours (an increase
of 491). The
increase was due to industry
growth, resulting in an increased number of respondents and
recordkeepers. Thus,
we are characterizing the increases as adjustments.
For IC#1, we estimate that the number of respondents have increased from 32 to 35, causing the annual number of responses to increase from 5,920 to 6,965 (an increase of 1,045) and the annual hour burden to increase from 1,006 to 1,184 (an increase of 178). We are characterizing the increase as an adjustment because it is based on the increase in the number of reports received by FDA in FY 2011, FY 2012, and FY 2013, caused by industry growth.
For IC#2, we estimate that the number of respondents have increased from 32 to 35, causing the annual number of responses to increase from 5,920 to 6,965 (an increase of 1,045) and the annual hour burden to increase from 296 to 348 (an increase of 52). We also are characterizing this increase as an adjustment because it is based on the increase in the number of reports received by FDA in FY 2011, FY 2012, and FY 2013.
For IC#3, we estimate that the number of recordkeepers have increased from 32 to 35, causing the annual number of records to increase from 5,920 to 6,965 (an increase of 1,045) and the annual hour burden to increase from 1,480 to 1,741 (an increase of 261). We are characterizing the increase as an adjustment because it is based on the increase in the number of records maintained by industry in FY 2011, FY 2012, and FY 2013.
Table 3—Summary of Change in Responses and Hour Burden |
||
IC Number |
Change in Responses |
Change in Hour Burden |
IC#1 |
1,045 |
178 |
IC#2 |
1,045 |
52 |
IC#3 |
1,045 |
261 |
Total Change |
3,135 |
491 |
16. Plans for Tabulation and Publication and Project Time Schedule
No
comprehensive tabulation of the data is planned or anticipated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA
has no reason for not displaying the OMB approval date.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There
are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Bean, Domini |
| File Modified | 2014-07-07 |
| File Created | 2014-04-29 |