Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method; Correction, 47798-47799 [2020-17177]
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Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
In the Federal Register of April 6,
2016 (81 FR 19976), we made available
a draft guidance for industry entitled
‘‘Inorganic Arsenic in Rice Cereals for
Infants: Action Level.’’ We also
announced the availability of two
related scientific documents: a
document entitled ‘‘Supporting
Document for Action Level for Inorganic
Arsenic in Rice Cereals for Infants’’
(supporting document), and a risk
assessment entitled ‘‘Arsenic in Rice
and Rice Products Risk Assessment:
Report’’ (the risk assessment report). We
gave interested parties an opportunity to
submit comments by July 5, 2016, and
later extended the comment period to
July 19, 2016 (see 81 FR 42714 (June 30,
2016)).
This guidance finalizes FDA’s action
level for inorganic arsenic in rice cereals
for infants of 100 micrograms per
kilogram (mg/kg) or 100 parts per billion
(ppb) and identifies FDA’s intended
sampling and enforcement approach.
The basis for the action level is set forth
in the revised supporting document.
The revised supporting document as
well as the risk assessment report
originally made available on April 6,
2016 (81 FR 19976), can be accessed at
www.regulations.gov. The revised
supporting document reviews data on
inorganic arsenic levels in rice cereals
for infants, health effects, and
achievability and explains FDA’s
rationale for identifying an action level
of 100 mg/kg for inorganic arsenic in rice
cereals for infants.
Arsenic is present in the environment
as a naturally occurring substance or as
a result of contamination from human
activity. In foods, arsenic may be
present as inorganic arsenic (the
primary toxic form of arsenic) or organic
arsenic. Exposure to inorganic arsenic is
associated with adverse human health
effects including cancer and
neurodevelopmental effects. Rice and
rice products are common in the
American diet, and FDA sampling data
have demonstrated that rice and rice
products have higher levels of inorganic
arsenic than other foods. Furthermore,
rice and rice products are a greater
potential source of dietary inorganic
arsenic exposure for infants and
children than for adults, because the
dietary patterns of infants and children
are often less varied than those of
adults, and because infants and children
consume more food relative to their
body weight than do adults. We expect
that that the 100 mg/kg action level,
though non-binding, will help protect
the public health, by encouraging
manufacturers to reduce levels of
inorganic arsenic in rice cereals for
infants, and we also expect that this
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level is achievable by industry with the
use of current good manufacturing
practices. We intend to consider the
action level of 100 mg/kg or 100 ppb
inorganic arsenic as an important source
of information for determining whether
infant rice cereal is adulterated within
the meaning of section 402(a)(1) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 342(a)(1)).
Comments on the draft guidance
requested that we consider establishing
action levels for rice-based foods other
than infant cereal, lower the action level
under 100 ppb, and questioned the
achievability of the action level of 100
ppb for inorganic arsenic in infant rice
cereals. However, we did not receive
new data from the comments supporting
establishment of either lower or higher
action levels. We determined that we
should prioritize efforts to reduce infant
exposure to inorganic arsenic from rice
because rice intake, primarily through
infant rice cereal, is about three times
greater for infants than adults in relation
to body weight (Ref. 1), and
epidemiologic data show that early life
exposure to inorganic arsenic, including
dietary exposure, can result in a child’s
decreased performance on certain
developmental tests that measure
learning (Ref. 1). Thus, the guidance
finalizes the approach presented in the
draft guidance.
Other comments suggested
modifications to the risk assessment
report. We note that the risk assessment
report underwent extensive interagency
review and external peer review before
we made it available to the public. None
of these comments supported a
determination that the risk assessment
report needs to be modified. We will
continue to monitor research
developments on non-cancer adverse
health effects, such as
neurodevelopmental effects,
cardiovascular disease, and diabetes, to
determine if new data support changes
to the risk assessment report or
guidance.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act is
not required.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
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IV. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. FDA, ‘‘Arsenic in Rice and Rice Products
Risk Assessment: Report,’’ 2016, https://
www.fda.gov/Food/FoodScienceResearch/
RiskSafetyAssessment/ucm485278.htm.
Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–17169 Filed 8–5–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0955]
Phibro Animal Health Corp.; Carbadox
in Medicated Swine Feed; Revocation
of Approved Method; Correction
Food and Drug Administration,
Health and Human Services (HHS).
AGENCY:
ACTION:
Proposed order; correction.
The Food and Drug
Administration (FDA) is correcting a
proposed order to revoke the approved
method for detecting residues of
carbadox, a carcinogenic new animal
drug used in swine feed. The document
was published with an incorrect docket
number. This document corrects that
error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Diane Heinz, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5692,
diane.heinz@fda.hhs.gov.
In the
Federal Register of July 20, 2020, in FR
Doc. 2020–15246, on page 43853, the
following correction is made:
On page 43853, in the second column,
in the header of the document, and also
in the third column under Instructions,
‘‘Docket No. FDA–2016–N–0832’’ is
corrected to read ‘‘Docket No. FDA–
2020–N–0955’’.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06AUN1.SGM
06AUN1
Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
Dated: August 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17177 Filed 8–5–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3771]
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Requirements and
Commitments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
Agency’s annual report entitled ‘‘Report
on the Performance of Drug and
Biologics Firms in Conducting
Postmarketing Requirements and
Commitments.’’ Under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), FDA is required to report annually
on the status of postmarketing
requirements (PMRs) and postmarketing
commitments (PMCs) required of, or
agreed upon by, application holders of
approved drug and biological products.
The report on the status of the studies
and clinical trials that applicants have
agreed to, or are required to, conduct is
on the FDA’s ‘‘Postmarketing
Requirements and Commitments:
Reports’’ web page.
FOR FURTHER INFORMATION CONTACT:
Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5367, Silver Spring,
MD 20993–0002, 301–796–0700; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
I. Background
Section 506B(c) of the FD&C Act (21
U.S.C. 356b(c)) requires FDA to publish
an annual report on the status of
postmarketing studies that applicants
have committed to, or are required to
conduct, and for which annual status
reports have been submitted.
Under §§ 314.81(b)(2)(vii) and 601.70
(21 CFR 314.81(b)(2)(vii) and 601.70),
applicants of approved drugs and
licensed biologics are required to submit
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annually a report on the status of each
clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical
toxicology study or clinical trial either
required by FDA (PMRs) or that they
have committed to conduct (PMCs),
either at the time of approval or after
approval of their new drug application,
abbreviated new drug application, or
biologics license application. The status
of PMCs concerning chemistry,
manufacturing, and production controls
and the status of other studies or
clinical trials conducted on an
applicant’s own initiative are not
required to be reported under
§§ 314.81(b)(2)(vii) and 601.70 and are
not addressed in this report.
Furthermore, section 505(o)(3)(E) of the
FD&C Act (21 U.S.C. 355(o)(3)(E))
requires that applicants report
periodically on the status of each
required study or clinical trial and each
study or clinical trial ‘‘otherwise
undertaken . . . to investigate a safety
issue . . . . ’’
An applicant must report on the
progress of the PMR/PMC on the
anniversary of the drug product’s
approval 1 until the PMR/PMC is
completed or terminated and FDA
determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either
no longer feasible or would no longer
provide useful information.
II. Fiscal Year 2019 Report
With this notice, FDA is announcing
the availability of the Agency’s annual
report entitled ‘‘Report on the
Performance of Drug and Biologics
Firms in Conducting Postmarketing
Requirements and Commitments.’’
Information in this report covers any
PMR/PMC that was established, in
writing, at the time of approval or after
approval of an application or a
supplement to an application and
summarizes the status of PMRs/PMCs in
fiscal year (FY) 2019 (i.e., as of
September 30, 2019). Information
summarized in the report reflects
combined data from the Center for Drug
Evaluation and Research and the Center
for Biologics Evaluation and Research
and includes the following: (1) The
number of applicants with open PMRs/
PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant
submission of the annual status reports
1 An applicant must submit an annual status
report on the progress of each open PMR/PMC
within 60 days of the anniversary date of U.S.
approval of the original application or on an
alternate reporting date that was granted by FDA in
writing. Some applicants have requested and been
granted by FDA alternate annual reporting dates to
facilitate harmonized reporting across multiple
applications.
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(ASRs); (4) FDA-verified status of open
PMRs/PMCs reported in
§ 314.81(b)(2)(vii) or § 601.70 ASRs; (5)
the status of closed PMRs/PMCs; and (6)
the distribution of the status by fiscal
year of establishment 2 (FY2013 to
FY2019) for PMRs and PMCs open at
the end of FY2019, or those closed
within FY2019. Additional information
about PMRs/PMCs is provided on FDA’s
website at https://www.fda.gov/drugs/
guidance-compliance-regulatoryinformation/postmarket-requirementsand-commitments.
Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17113 Filed 8–5–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2032]
Limited Population Pathway for
Antibacterial and Antifungal Drugs;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Limited
Population Pathway for Antibacterial
and Antifungal Drugs.’’ This guidance
provides information on the
implementation of the limited
population pathway provision of the
21st Century Cures Act (Cures Act),
which established the limited
population pathway for antibacterial
and antifungal drugs (LPAD pathway).
This guidance finalizes the draft
guidance of the same name issued on
June 13, 2018.
DATES: The announcement of the
guidance is published in the Federal
Register on August 6, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
2 The establishment date is the date of the formal
FDA communication to the applicant that included
the final FDA-required (PMR) or requested (PMC)
postmarketing study or clinical trial.
E:\FR\FM\06AUN1.SGM
06AUN1
]]>Agencies
[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47798-47799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17177]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0955]
Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed;
Revocation of Approved Method; Correction
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Proposed order; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a
proposed order to revoke the approved method for detecting residues of
carbadox, a carcinogenic new animal drug used in swine feed. The
document was published with an incorrect docket number. This document
corrects that error.
FOR FURTHER INFORMATION CONTACT: Diane Heinz, Center for Veterinary
Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-5692, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of July 20, 2020, in
FR Doc. 2020-15246, on page 43853, the following correction is made:
On page 43853, in the second column, in the header of the document,
and also in the third column under Instructions, ``Docket No. FDA-2016-
N-0832'' is corrected to read ``Docket No. FDA-2020-N-0955''.
[[Page 47799]]
Dated: August 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17177 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P
