83 FR 7198 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 34 (February 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 34 (February 20, 2018)
| Page Range | 7198-7199 | |
| FR Document | 2018-03339 |
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)] [Notices] [Pages 7198-7199] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03339] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0025] Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA regulations requiring the declaration of color additives on animal food labels. DATES: Submit either electronic or written comments on the collection of information by April 23, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 23, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2009-N-0025 for ``Animal Food Labeling; Declaration of Certifiable Color Additives.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's [[Page 7199]] estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Animal Food Labeling; Declaration of Certifiable Color Additives--21 CFR 501.22(k) OMB Control Number 0910-0721--Extension This information collection is associated with requirements under Sec. 501.22(k) (21 CFR 501.22(k)) in which animal food manufacturers must declare the presence of certified and noncertified color additives in their animal food products on the product label. We issued this regulation in response to the Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535) to make animal food regulations consistent with the regulations regarding the declaration of color additives on human food labels and to provide animal owners with information on the color additives used in animal food. Animal owners use the information to become knowledgeable about the foods they purchase for their animals. Color additive information enables a consumer to comparison shop and to avoid substances to which their animals may be sensitive. Description of Respondents: Respondents to this collection of information are manufacturers of pet food products that contain color additives. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section/activity Number of disclosures Total annual Average burden per disclosure Total hours respondents per respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- 501.22(k); labeling of color additive or lake of 3,120 0.8292 2,587 0.25 (15 minutes)................. 647 color additive; labeling of color additives not subject to certification. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Having become effective November 18, 2013, we estimate that the burden associated with the labeling requirements under Sec. 501.22(k) apply only to new product labels. Because the vast majority of animal food products that contain certified color additives are pet foods, we limit our burden estimate to reviewing labels for the use of certified color additives to pet food manufacturers subject to this regulation. Based on A.C. Nielsen Data, we estimate that the number of animal food product units subject to Sec. 501.22(k) for which sales of the products are greater than zero is 25,874. Assuming that the flow of new products is 10 percent per year, then 2,587 new animal food products subject to Sec. 501.22(k) will become available on the market each year. We also estimate that there are approximately 3,120 manufacturers of pet food subject to either Sec. 501.22(k)(1) or (k)(2). Assuming the approximately 2,587 new products are split equally among the firms, then each firm would prepare labels for approximately 0.8292 new products per year (2,587 new products/3,120 firms is approximately 0.8292 labels per firm). We expect that firms prepare the required labeling for their products in a manner that takes into account at one time all information required to be disclosed on their product labels. Based on our experience with reviewing pet food labeling, we estimate that firms would require less than 0.25 hour (15 minutes) per product to comply with the requirement to include the color additive information pursuant to Sec. 501.22(k). The total burden of this activity is 647 hours (2,587 labels x 0.25 hour/label is approximately 647 hours). The burden for this information collection has not changed since the last OMB approval. Dated: February 13, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03339 Filed 2-16-18; 8:45 am] BILLING CODE 4164-01-P
![7198 Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
Dated: February 13, 2018. the docket unchanged. Because your https://www.regulations.gov. Submit
Leslie Kux, comment will be made public, you are both copies to the Dockets Management
Associate Commissioner for Policy. solely responsible for ensuring that your Staff. If you do not wish your name and
[FR Doc. 2018–03343 Filed 2–16–18; 8:45 am] comment does not include any contact information to be made publicly
BILLING CODE 4164–01–P confidential information that you or a available, you can provide this
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or must identify this information as
HUMAN SERVICES confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
Food and Drug Administration that if you include your name, contact except in accordance with 21 CFR 10.20
[Docket No. FDA–2009–N–0025] information, or other information that and other applicable disclosure law. For
identifies you in the body of your more information about FDA’s posting
Agency Information Collection comments, that information will be of comments to public dockets, see 80
Activities; Proposed Collection; posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
Comment Request; Animal Food • If you want to submit a comment the information at: https://www.gpo.gov/
Labeling; Declaration of Certifiable with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
Color Additives do not wish to be made available to the 23389.pdf.
public, submit the comment as a Docket: For access to the docket to
AGENCY: Food and Drug Administration, written/paper submission and in the read background documents or the
HHS. manner detailed (see ‘‘Written/Paper electronic and written/paper comments
ACTION: Notice. Submissions’’ and ‘‘Instructions’’). received, go to https://
SUMMARY: The Food and Drug Written/Paper Submissions www.regulations.gov and insert the
Administration (FDA, Agency, or we) is docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the
announcing an opportunity for public follows: ‘‘Search’’ box and follow the prompts
comment on the proposed collection of • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
certain information by the Agency. written/paper submissions): Dockets
Under the Paperwork Reduction Act of Staff, 5630 Fishers Lane, Rm. 1061,
Management Staff (HFA–305), Food and Rockville, MD 20852.
1995 (PRA), Federal Agencies are Drug Administration, 5630 Fishers
required to publish notice in the FOR FURTHER INFORMATION CONTACT: Ila
Lane, Rm. 1061, Rockville, MD 20852.
Federal Register concerning each • For written/paper comments S. Mizrachi, Office of Operations, Food
proposed collection of information, submitted to the Dockets Management and Drug Administration, Three White
including each proposed extension of an Staff, FDA will post your comment, as Flint North, 10A–12M, 11601
existing collection of information, and well as any attachments, except for Landsdown St., North Bethesda, MD
to allow 60 days for public comment in information submitted, marked and 20852, 301–796–7726, PRAStaff@
response to the notice. This notice identified, as confidential, if submitted fda.hhs.gov.
solicits comments on the information as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
collection provisions of FDA regulations Instructions: All submissions received PRA (44 U.S.C. 3501–3520), Federal
requiring the declaration of color must include the Docket No. FDA– Agencies must obtain approval from the
additives on animal food labels. 2009–N–0025 for ‘‘Animal Food Office of Management and Budget
DATES: Submit either electronic or Labeling; Declaration of Certifiable (OMB) for each collection of
written comments on the collection of Color Additives.’’ Received comments, information they conduct or sponsor.
information by April 23, 2018. those filed in a timely manner (see ‘‘Collection of information’’ is defined
ADDRESSES: You may submit comments ADDRESSES), will be placed in the docket in 44 U.S.C. 3502(3) and 5 CFR
as follows. Please note that late, and, except for those submitted as 1320.3(c) and includes Agency requests
untimely filed comments will not be ‘‘Confidential Submissions,’’ publicly or requirements that members of the
considered. Electronic comments must viewable at https://www.regulations.gov public submit reports, keep records, or
be submitted on or before April 23, or at the Dockets Management Staff provide information to a third party.
2018. The https://www.regulations.gov between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
electronic filing system will accept through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
comments until midnight Eastern Time • Confidential Submissions—To Agencies to provide a 60-day notice in
at the end of April 23, 2018. Comments submit a comment with confidential the Federal Register concerning each
received by mail/hand delivery/courier information that you do not wish to be proposed collection of information,
(for written/paper submissions) will be made publicly available, submit your including each proposed extension of an
considered timely if they are comments only as a written/paper existing collection of information,
postmarked or the delivery service submission. You should submit two before submitting the collection to OMB
acceptance receipt is on or before that copies total. One copy will include the for approval. To comply with this
date. information you claim to be confidential requirement, FDA is publishing notice
with a heading or cover note that states of the proposed collection of
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
CONFIDENTIAL INFORMATION.’’ The With respect to the following
sradovich on DSK3GMQ082PROD with NOTICES
Submit electronic comments in the
following way: Agency will review this copy, including collection of information, FDA invites
• Federal eRulemaking Portal: the claimed confidential information, in comments on these topics: (1) Whether
https://www.regulations.gov. Follow the its consideration of comments. The the proposed collection of information
instructions for submitting comments. second copy, which will have the is necessary for the proper performance
Comments submitted electronically, claimed confidential information of FDA’s functions, including whether
including attachments, to https:// redacted/blacked out, will be available the information will have practical
www.regulations.gov will be posted to for public viewing and posted on utility; (2) the accuracy of FDA’s
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![Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices 7199
estimate of the burden of the proposed Animal Food Labeling; Declaration of regarding the declaration of color
collection of information, including the Certifiable Color Additives—21 CFR additives on human food labels and to
validity of the methodology and 501.22(k) provide animal owners with
assumptions used; (3) ways to enhance information on the color additives used
OMB Control Number 0910–0721—
the quality, utility, and clarity of the in animal food. Animal owners use the
Extension
information to be collected; and (4) information to become knowledgeable
ways to minimize the burden of the This information collection is about the foods they purchase for their
collection of information on associated with requirements under animals. Color additive information
respondents, including through the use § 501.22(k) (21 CFR 501.22(k)) in which enables a consumer to comparison shop
of automated collection techniques, animal food manufacturers must declare and to avoid substances to which their
when appropriate, and other forms of the presence of certified and animals may be sensitive.
information technology. noncertified color additives in their Description of Respondents:
animal food products on the product Respondents to this collection of
label. We issued this regulation in information are manufacturers of pet
response to the Nutrition Labeling and food products that contain color
Education Act of 1990 (Pub. L. 101–535) additives.
to make animal food regulations FDA estimates the burden of this
consistent with the regulations collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR Section/activity burden per Total hours
respondents per disclosures disclosure
respondent
501.22(k); labeling of color additive or lake of color addi- 3,120 0.8292 2,587 0.25 (15 min- 647
tive; labeling of color additives not subject to certification. utes).
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Having become effective November to comply with the requirement to would constitute a clearly unwarranted
18, 2013, we estimate that the burden include the color additive information invasion of personal privacy.
associated with the labeling pursuant to § 501.22(k). The total Name of Committee: Center for Scientific
requirements under § 501.22(k) apply burden of this activity is 647 hours Review Special Emphasis Panel Topics on
only to new product labels. Because the (2,587 labels × 0.25 hour/label is Diseases of Metabolism.
vast majority of animal food products approximately 647 hours). The burden Date: March 6, 2018.
that contain certified color additives are for this information collection has not Time: 11:00 a.m. to 6:00 p.m.
pet foods, we limit our burden estimate changed since the last OMB approval. Agenda: To review and evaluate grant
applications.
to reviewing labels for the use of Dated: February 13, 2018. Place: National Institutes of Health, 6701
certified color additives to pet food Leslie Kux, Rockledge Drive, Bethesda, MD 20892,
manufacturers subject to this regulation. Associate Commissioner for Policy. (Virtual Meeting).
Based on A.C. Nielsen Data, we estimate Contact Person: Liliana N. Berti-Mattera,
[FR Doc. 2018–03339 Filed 2–16–18; 8:45 am]
that the number of animal food product Ph.D., Scientific Review Officer, Center for
units subject to § 501.22(k) for which BILLING CODE 4164–01–P Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 4215,
sales of the products are greater than
Bethesda, MD 20892, 301–827–7609,
zero is 25,874. Assuming that the flow DEPARTMENT OF HEALTH AND liliana.berti-mattera@nih.gov.
of new products is 10 percent per year, HUMAN SERVICES Name of Committee: Center for Scientific
then 2,587 new animal food products Review Special Emphasis Panel Member
subject to § 501.22(k) will become National Institutes of Health Conflict: Neurodevelopmental Issues—
available on the market each year. We Immunology, Epilepsy, Microbiome.
also estimate that there are Center for Scientific Review; Notice of Date: March 9, 2018.
approximately 3,120 manufacturers of Closed Meetings Time: 10:00 a.m. to 12:00 p.m.
pet food subject to either § 501.22(k)(1) Agenda: To review and evaluate grant
Pursuant to section 10(d) of the applications.
or (k)(2). Assuming the approximately
Federal Advisory Committee Act, as Place: National Institutes of Health, 6701
2,587 new products are split equally Rockledge Drive, Bethesda, MD 20892,
among the firms, then each firm would amended, notice is hereby given of the
(Telephone Conference Call).
prepare labels for approximately 0.8292 following meetings. Contact Person: Samuel C. Edwards, Ph.D.,
new products per year (2,587 new The meetings will be closed to the Chief, Brain Disorders and Clinical
products/3,120 firms is approximately public in accordance with the Neuroscience, Center for Scientific Review,
0.8292 labels per firm). We expect that provisions set forth in sections National Institutes of Health, 6701 Rockledge
firms prepare the required labeling for 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Drive, Room 5210, MSC 7846, Bethesda, MD
sradovich on DSK3GMQ082PROD with NOTICES
20892, (301) 435–1246, edwardss@
their products in a manner that takes as amended. The grant applications and
csr.nih.gov.
into account at one time all information the discussions could disclose
Name of Committee: Center for Scientific
required to be disclosed on their confidential trade secrets or commercial Review Special Emphasis Panel SBIB
product labels. Based on our experience property such as patentable material, Clinical Pediatric and Fetal Applications
with reviewing pet food labeling, we and personal information concerning Subcommittee.
estimate that firms would require less individuals associated with the grant Date: March 9, 2018.
than 0.25 hour (15 minutes) per product applications, the disclosure of which Time: 1:00 p.m. to 6:00 p.m.
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Document Created: 2018-02-17 02:29:44
Document Modified: 2018-02-17 02:29:44
| 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 | Submit either electronic or written comments on the collection of information by April 23, 2018. | |
| 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 | 83 FR 7198 |
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