82 FR 44420 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 183 (September 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 183 (September 22, 2017)
| Page Range | 44420-44422 | |
| FR Document | 2017-20245 |
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)] [Notices] [Pages 44420-44422] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [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. 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
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on average would be needed per applications and submissions. It is information necessary to complete the
response for certifications which assumed that the sponsor/applicant/ form in an efficient manner.
accompany NDA, BLA, PMA, HDE, submitter has electronic capabilities FDA estimates the burden of this
510(k), and ANDA marketing allowing them to retrieve the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Number of Number of Average
respondents respondents Total annual
FDA center activity responses per burden per Total hours
(investigational (marketing responses
respondent response
applications) applications)
CDER
New Applications (IND) ................ 1,669 ........................ 1 1,669 0.25 (15 minutes) .. 417
Clinical Protocol Amendments 15,285 ........................ 1 15,285 0.25 (15 minutes) .. 3,821
(IND).
New Marketing Applications/Re- ............................ 198 1 198 0.75 (45 minutes) .. 149
submissions (NDA/BLA).
Clinical Amendments to Marketing ............................ 1,067 1 1,067 0.75 (45 minutes) .. 800
Applications.
Efficacy Supplements/Resubmis- ............................ 219 1 219 0.75 (45 minutes) .. 164
sions.
CBER
New Applications (IND) ................ 381 ........................ 1 381 0.25 (15 minutes) .. 95
Clinical Protocol Amendments 456 ........................ 1 456 0.25 (15 minutes) .. 114
(IND).
New Marketing Applications/Re- ............................ 54 1 54 0.75 (45 minutes) .. 41
submissions (NDA/BLA).
Clinical Amendments to Marketing ............................ 0 1 0 0.75 (45 minutes) .. 0
Applications.
Efficacy Supplements/Resubmis- ............................ 34 1 34 0.75 (45 minutes) .. 26
sions (BLA only).
CDRH
New Marketing Applications (in- ............................ 330 1 330 0.75 (45 minutes) .. 247
cludes PMAs, HDEs, Supple-
ments and 510(k)s expected to
contain clinical data).
OGD
Original Applications ..................... ............................ 1,036 1 ........................ 0.75 (45 minutes) .. 777
Bioequivalence Supplements/ ............................ 698 1 ........................ 0.75 (45 minutes) .. 524
Amendments.
Total ...................................... ............................ ........................ ........................ ........................ ............................... 7,175
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 15, 2017. DEPARTMENT OF HEALTH AND Office of Management and Budget
Anna K. Abram, HUMAN SERVICES (OMB) for review and clearance under
Deputy Commissioner for Policy, Planning, the Paperwork Reduction Act of 1995.
Legislation, and Analysis. Food and Drug Administration
DATES: Fax written comments on the
[FR Doc. 2017–20227 Filed 9–21–17; 8:45 am] [Docket No. FDA–2010–N–0622] collection of information by October 23,
BILLING CODE 4164–01–P 2017.
Agency Information Collection
Activities; Submission for Office of ADDRESSES: To ensure that comments on
Management and Budget Review; the information collection are received,
Comment Request; Color Additive OMB recommends that written
Certification Requests and comments be faxed to the Office of
Recordkeeping Information and Regulatory Affairs,
AGENCY: Food and Drug Administration, OMB, Attn: FDA Desk Officer, Fax: 202–
HHS. 395–7285, or emailed to oira_
ACTION: Notice. submission@omb.eop.gov. All
comments should be identified with the
SUMMARY: The Food and Drug OMB control number 0910–0216. Also
Administration (FDA) is announcing include the FDA docket number found
that a proposed collection of in brackets in the heading of this
information has been submitted to the document.
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![44422 Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
We base our estimate on our review DATES: Fax written comments on the responsible party to notify the
of the certification requests received collection of information by October 23, immediate previous source(s) and/or
over the past 3 fiscal years (FY). The 2017. immediate subsequent recipient(s) of a
annual burden estimate for this ADDRESSES: To ensure that comments on reportable food (section 417(d)(6)(B)(i)
information collection is 3,536 hours. the information collection are received, to (ii) of the FD&C Act). Similarly, we
The estimated reporting burden for this OMB recommends that written may also require the responsible party
information collection is 1,655 hours comments be faxed to the Office of that is notified (i.e., the immediate
and the estimated recordkeeping burden Information and Regulatory Affairs, previous source and/or immediate
for this information collection is 1,881 OMB, Attn: FDA Desk Officer, Fax: 202– subsequent recipient) to notify their
hours. From FY 2014 to FY 2016, we 395–7285, or emailed to oira_ own immediate previous source(s) and/
processed an average of 7,524 responses submission@omb.eop.gov. All or immediate subsequent recipient(s) of
(requests for certification of batches of comments should be identified with the a reportable food (section 417(d)(7)(C)(i)
color additives) per year. There were 38 OMB control number 0910–0643. Also to (ii) of the FD&C Act).
different respondents, corresponding to include the FDA docket number found Notification to the immediate
an average of approximately 198 in brackets in the heading of this previous source(s) and immediate
responses from each respondent per document. subsequent recipient(s) of the article of
year. Using information from industry food may be accomplished by electronic
FOR FURTHER INFORMATION CONTACT: Ila communication methods such as email,
personnel, we estimate that an average
S. Mizrachi, Office of Operations, Food fax, or text messaging or by telegrams,
of 0.22 hour per response is required for
and Drug Administration, Three White mailgrams, or first-class letters.
reporting (preparing certification
Flint North, 10A–12M, 11601 Notification may also be accomplished
requests and accompanying samples)
Landsdown St., North Bethesda, MD by telephone call or other personal
and an average of 0.25 hour per
20852, 301–796–7726, PRAStaff@ contacts but we recommend that such
response is required for recordkeeping.
fda.hhs.gov. notifications also be confirmed by one
FDA’s web-based Color Certification
information system allows submitters to SUPPLEMENTARY INFORMATION: In of the previous methods and/or
request color certification online, follow compliance with 44 U.S.C. 3507, FDA documented in an appropriate manner.
their submissions through the process, has submitted the following proposed We may require that the notification
and obtain information on account collection of information to OMB for include any or all of the following data
status. The system sends back the review and clearance. elements: (1) The date on which the
certification results electronically, article of food was determined to be a
Third Party Disclosure and reportable food; (2) a description of the
allowing submitters to sell their Recordkeeping Requirements for
certified color before receiving hardcopy article of food including the quantity or
Reportable Food—21 U.S.C. 350f amount; (3) the extent and nature of the
certificates. Any delays in the system
result only from shipment of color OMB Control Number 0910–0643— adulteration; (4) the results of any
additive samples to FDA’s Office of Extension investigation of the cause of the
Cosmetics and Colors for analysis. adulteration if it may have originated
The Federal Food, Drug, and Cosmetic with the responsible party, if known; (5)
Dated: September 15, 2017. Act (the FD&C Act), as amended by the the disposition of the article of food,
Anna K. Abram, Food and Drug Administration when known; (6) product information
Deputy Commissioner for Policy, Planning, Amendments Act of 2007 (FDAAA) typically found on packaging including
Legislation, and Analysis. (Pub. L. 110–85), requires the product codes, use-by dates, and the
[FR Doc. 2017–20245 Filed 9–21–17; 8:45 am] establishment of a Reportable Food names of manufacturers, packers, or
BILLING CODE 4164–01–P
Registry (the Registry) by which distributors sufficient to identify the
instances of reportable food must be article of food; (7) contact information
submitted to FDA by responsible parties for the responsible party; (8) contact
DEPARTMENT OF HEALTH AND and may be submitted by public health information for parties directly linked in
HUMAN SERVICES officials. Section 417 of the FD&C Act the supply chain and notified under
(21 U.S.C. 350f) defines ‘‘reportable section 417(d)(6)(B) or 417(d)(7)(C) of
Food and Drug Administration food’’ as an ‘‘article of food (other than the FD&C Act, as applicable; (9) the
infant formula) for which there is a information required by FDA to be
[Docket No. FDA–2009–N–0501] reasonable probability that the use of, or included in the notification provided by
Agency Information Collection exposure to, such article of food will the responsible party involved under
Activities; Submission for Office of cause serious adverse health section 417(d)(6)(B) or 417(d)(7)(C) of
Management and Budget Review; consequences or death to humans or the FD&C Act or required to report
Comment Request; Third Party animals.’’ (Section 417(a)(2) of the FD&C under section 417(d)(7)(A) of the FD&C
Disclosure and Recordkeeping Act.) We believe that the most efficient Act; and (10) the unique number
Requirements for Reportable Food and cost effective means to implement described in section 417(d)(4) of the
the Registry is by utilizing our FD&C Act (section 417(d)(6)(B)(iii)(I),
AGENCY: Food and Drug Administration, electronic Safety Reporting Portal. The (d)(7)(C)(iii)(I), and (e) of the FD&C Act).
HHS. information collection provisions We may also require that the
ACTION: Notice. associated with the submission of notification provides information about
reportable food reports has been the actions that the recipient of the
SUMMARY: The Food and Drug approved under OMB control number notification will perform and/or any
Administration (FDA) is announcing 0910–0643. other information we may require
that a proposed collection of In conjunction with the reportable (section 417(d)(6)(B)(iii)(II) and (III),
information has been submitted to the foods requirements, section 417 of the (d)(7)(C)(iii)(II) and (III) of the FD&C
Office of Management and Budget FD&C Act also establishes third party Act).
(OMB) for review and clearance under disclosure and recordkeeping burdens. Section 417(g) of the FD&C Act
the Paperwork Reduction Act of 1995. Specifically, we may require the requires that responsible persons
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Document Created: 2017-09-22 01:52:58
Document Modified: 2017-09-22 01:52:58
| 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 October 23, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 44420 |
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