Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives, 36284-36285 [2021-14655]
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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
of the RFPs. The responses to the RFPs
were directed in the HHS Notice and in
the RFP for Personal Prescription Drug
Importation issued on September 24,
2020, and revised on January 13, 2021,
to be submitted to an HHS email
address: import@hhs.gov, while the RFP
for Insulin Reimportation Programs
issued on September 24, 2020, and
revised on January 13, 2021, directed
that responses be sent to import@
hhs.gov and to the Director of the FDA
Import Division in the region of the
intended port of entry. The Department
is not aware that any proposals were
received in response to the HHS Notice
or RFPs. The HHS Notice, RFPs, and
FAQs are withdrawn. All website
statements and other informal issuances
with respect to the HHS Notice and
RFPs are also withdrawn. Accordingly,
no proposals submitted to HHS or FDA
in response to the HHS Notice or RFPs
on or after July 9, 2021 will be
considered by HHS or FDA. HHS
intends to consider alternatives to the
RFPs.
Dated: June 11, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
Dated: June 28, 2021.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–14637 Filed 7–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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: Submit written comments
(including recommendations) on the
collection of information by August 9,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0721. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
SUMMARY:
Animal Food Labeling; Declaration of
Certified and Non-Certified Color
Additives
Food and Drug Administration
[Docket No. FDA–2009–N–0025]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Food
Labeling; Declaration of Certified and
Non-Certified Color Additives
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
ACTION:
OMB Control Number 0910–0721—
Extension
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to issue regulations
concerning animal food. Specifically,
section 403(i) of the FD&C Act (21
U.S.C. 343(i)) requires that certified
color additives used in or on a food
must be declared by their common or
usual names and not be designated by
the collective term ‘‘colorings.’’ Our
regulations in part 501 (21 CFR part
501) set forth the requirements for
animal food labeling. Under
§ 501.22(k)(21 CFR 501.22(k)), animal
food manufacturers must declare on the
animal food label the presence of
certified and noncertified color
additives in their animal food products.
Our animal food labeling regulation at
§ 501.22(k) is consistent with the
regulations requiring the declaration of
color additives on human food labels.
The purpose of the labeling is 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.
In the Federal Register of March 4,
2021 (86 FR 12690), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received 22 comments
expressing the importance of color
additive information on pet food
labeling, along with other ingredient
disclosures. FDA appreciates these
comments; at this time, we are not
revising the regulations found at
§ 501.22(k) related to color additive
information on the labeling of animal
food.
FDA estimates the burden of this
collection of information as follows:
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
respondents
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR section; activity
501.22(k); labeling of color additive or lake of color
additive; labeling of color additives not subject to
certification.
1 There
Number of
disclosures
per respondent
3,120
0.8292
Total annual
disclosures
2,587
Average burden per
disclosure
0.25 (15 minutes) ......
are no capital costs or operating and maintenance costs associated with this collection of information.
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647
Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14655 Filed 7–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–1944]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; AJOVY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for AJOVY and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human biological product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by September 7, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
January 5, 2022. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 September 7,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 7, 2021.
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.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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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–
2019–E–1944 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; AJOVY.’’ 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, 240–402–7500.
• 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
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36285
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 § 10.20 (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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
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]]>Agencies
[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36284-36285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14655]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0025]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Food Labeling;
Declaration of Certified and Non-Certified Color Additives
AGENCY: Food and Drug Administration, Health and Human Services (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: Submit written comments (including recommendations) on the
collection of information by August 9, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0721. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Animal Food Labeling; Declaration of Certified and Non-Certified Color
Additives
OMB Control Number 0910-0721--Extension
FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to issue regulations concerning animal food.
Specifically, section 403(i) of the FD&C Act (21 U.S.C. 343(i))
requires that certified color additives used in or on a food must be
declared by their common or usual names and not be designated by the
collective term ``colorings.'' Our regulations in part 501 (21 CFR part
501) set forth the requirements for animal food labeling. Under Sec.
501.22(k)(21 CFR 501.22(k)), animal food manufacturers must declare on
the animal food label the presence of certified and noncertified color
additives in their animal food products. Our animal food labeling
regulation at Sec. 501.22(k) is consistent with the regulations
requiring the declaration of color additives on human food labels. The
purpose of the labeling is 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.
In the Federal Register of March 4, 2021 (86 FR 12690), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received 22 comments expressing the
importance of color additive information on pet food labeling, along
with other ingredient disclosures. FDA appreciates these comments; at
this time, we are not revising the regulations found at Sec. 501.22(k)
related to color additive information on the labeling of animal food.
FDA estimates the burden of this collection of information as
follows:
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 3,120 0.8292 2,587 0.25 (15 minutes)......................... 647
lake of 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.
[[Page 36285]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14655 Filed 7-8-21; 8:45 am]
BILLING CODE 4164-01-P
